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Johnson & Johnson announces new ICOTYDE® (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapyRevolutionary IL-23R targeted oral peptide delivers sustained skin clearance and a favorable safety profile in patients with psoriasis affecting sensitive, highly visible areas of the body60% of patients with scalp psoriasis and 89% with genital psoriasis achieved site-specific complete skin clearance at Week 112SPRING HOUSE, Pa., Oct. 2, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new two-year data from the Phase 3 ICONIC-TOTALa study demonstrating the positive impact of ICOTYDE® (icotrokinra) on high-impact plaque psoriasis (PsO) sites. ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor1, in adults and pediatric patients 12 years of age and older (adolescents).The late-breaking results, shared as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2026, evaluated adults and adolescents with at least moderate high-impact site involvement. Through Week 112, ICOTYDE demonstrated sustained skin clearance.2"People with plaque psoriasis that affect high-impact sites deal with severe functional disability and intense daily pain. Even when these affected areas cover a small percentage of the body, they often do not respond to topical creams, limit activity, and degrade mental health due to unrelenting symptoms," said Richard B. Warren, M.D., Ph.D., Professor of Dermatology, University of Manchester.b "These robust two-year data validate that ICOTYDE provides enduring skin clearance with a favorable safety profile, making it a pivotal advancement in plaque psoriasis treatment."ICOTYDE clinical data highlights2Among patients treated with ICOTYDE, rates of clear or almost clear skin (Investigator's Global Assessment [IGA] 0/1)c increased from 57% at Week 16 to 67% at Week 24 and 70% at Week 112.At Week 112, high rates of site-specific complete skin clearance were reported among ICOTYDE-treated patients:60% of patients with scalp psoriasis achieved a scalp-specific Investigator's Global Assessment (ss-IGA)d score of 0;89% of patients with genital psoriasis achieved a Physician's Global Assessment of Genitalia (sPGA-G)e score of 0;63% of patients with psoriasis affecting the hands and/or feet achieved a hand and/or foot Physician's Global Assessment (hf-PGA)f score of 0.Nail psoriasis improved over time, with mean percentage improvement in modified Nail Psoriasis Severity Index (mNAPSI)g increasing from 33% at Week 16 to 62% at Week 52 to 71% at Week 112.Safety findings through Week 112 remained consistent with the established safety profile of ICOTYDE, with no new safety signals identified.2 "Availability of long-term data are vital for informing the treatment of plaque psoriasis including particularly challenging areas of the body where conventional treatments may fall short," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "These two-year ICOTYDE results empower physicians to treat high-impact sites, knowing that data support sustained clinical outcomes for patients."Editor's notes:a. ICONIC-TOTAL evaluates the efficacy and safety of ICOTYDE compared with placebo in participants with at least moderate scalp, genital, and/or hand/foot PsO with once daily ICOTYDE or placebo, with placebo-to-ICOTYDE transition at Week 16.b. Dr. Warren is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.c. The Investigator's Global Assessment (IGA) is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease.3 d. The scalp-specific Investigator's Global Assessment (ss-IGA) is a five-point scale where scalp lesions are assessed in terms of clinical signs of redness, thickness, and scaliness on a severity score ranging from 0 to 4, where 0 indicates absence of disease, 1 is very mild, 2 is mild, 3 is moderate and 4 indicates severe disease.e. The Physician's Global Assessment of Genitalia (sPGA-G) is a six-point scale used to evaluate the severity of genital psoriasis at a given time point ranging from 0 to 5, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, 4 is severe and 5 indicates very severe disease.4f. The Physician's Global Assessment of Psoriasis on the Hands and/or Feet (hf-PGA) assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3) and severe (4).5g. The modified Nail Psoriasis Severity Index (mNAPSI) is a composite score used to assess the severity of nail psoriasis based on features of the nail matrix and nail bed, with scores ranging from 0 to 13 per fingernail, where 0 indicates no nail psoriasis and higher scores indicate greater disease severity.About the ICONIC clinical development program The pivotal Phase 3 ICONIC clinical development program includes four studies of ICOTYDE in patients with moderate-to-severe plaque PsO.ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary.6ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.7ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.8,9Additional studies underway include: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis; ICONIC-ASCEND (NCT06934226) in moderate-to-severe plaque psoriasis; ICONIC-UC (NCT071196748) in moderately to severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately to severely active Crohn's disease.10,11,12,13,14About plaque psoriasisPlaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.15 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.16 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.16 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.17 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.18 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.19About ICOTYDE® (icotrokinra) ICOTYDE® (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.1,20,21 ICOTYDE binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.22 Clinical significance of these findings is unknown.ICOTYDE is currently approved in the U.S. for the treatment of moderate-to-severe plaque PsO in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once daily upon waking with water on an empty stomach, at least 30 minutes before eating.23ICOTYDE is also approved in Europe, Japan and China for the treatment of adults and adolescents with psoriasis. ICOTYDE was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop ICOTYDE in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.24, 25, 26ICOTYDE is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.10,11,12,13,14 ICOTYDE INDICATION AND IMPORTANT SAFETY INFORMATIONWHAT IS ICOTYDE (icotrokinra)?
ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about ICOTYDE?Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE.Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including:fever, sweat, or chillscoughshortness of breathblood in your mucus (phlegm)muscle acheswarm, red, or painful skin or sores on your body different from your psoriasisweight lossdiarrhea or stomach painburning when you urinate or urinating more often than normalBefore taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you:have an infection that does not go away or that keeps coming back.have tuberculosis (TB) or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE.have kidney problems. are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.
 
Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com.are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of ICOTYDE? ICOTYDE may cause serious side effects. See "What is the most important information I should know about ICOTYDE?"The most common side effects of ICOTYDE include:headachenauseacoughfungal infectiontirednessThese are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.How should I take ICOTYDE?Take ICOTYDE exactly as your healthcare provider tells you to take it.Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide.If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day.Please read the full Prescribing Information, including Medication Guide, for ICOTYDE and discuss any questions that you have with your doctor.cp-564097v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Janssen Biotech, Inc. is a Johnson & Johnson company.Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ICOTYDE (icotrokinra). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. REFERENCES_____________________________________________
1 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.2 Richard B, et al. Data presentation. Long-term Durability and Safety of the Targeted Oral Peptide Icotrokinra for High-Impact Site Psoriasis: 2-year Findings From the ICONIC-TOTAL Randomized Controlled Trial. Late-breaking research presentation (Abstract #LB-245) at the European Academy of Dermatology and Venereology Congress. September 2026.3 Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009. Epub 2013 Dec 20. PMID: 24354461. Accessed October 2026.4 Merola JF, Bleakman AP, Gottlieb AB, et al. The Static Physician's Global Assessment of Genitalia: a clinical outcome measure for the severity of genital psoriasis. J Drugs Dermatol. 2017;16(8):793-7995 Goldblum O, et al. Validation of the physician's global assessment of psoriasis of the hands and/or feet as a clinical endpoint. J Am Acad Dermatol. 2013:68(4)Supplement1:AB218.6 Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. https://classic.clinicaltrials.gov/ct2/show/NCT06095115. Accessed October 2026.7 Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed October 2026.8 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate-to-severe Plaque Psoriasis. Identifier NCT06143878. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10. Accessed October 2026.9 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604.10 Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404. Accessed October 2026.11 A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424. Accessed October 2026.12 Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT06934226. https://clinicaltrials.gov/study/NCT06934226. Accessed October 2026.13 Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. https://clinicaltrials.gov/study/NCT07196748. Accessed October 2026.14 Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD). Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed October 2026.15 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed October 2026.16 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed October 2026..17 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/. Accessed October 2026.18 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed October 2026..19 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed October 2026..20 Razawy W, et al. The role of IL-23 receptor signaling in inflammation-mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.21 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.22 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.23 ICOTYDE® prescribing information.24 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed October 2026.25 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed October 2026.26 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed October 2026.  Media contact: 
Meg Farina
mfarina@its.jnj.com Investor contact: 
Jessica Margevich
investor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-announces-new-icotyde-icotrokinra-data-in-difficult-to-treat-plaque-psoriasis-with-proven-durability-through-2-years-affirming-its-use-as-a-powerful-first-line-systemic-therapy-302896648.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson announces new ICOTYDE® (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapy

New Global Survey by Johnson & Johnson Finds Most Women Don’t Connect Eye Health Changes with Menopause Johnson & Johnson, Naomi Watts and the American Optometric Association encourage women to make eye health part of midlife care Johnson & Johnson (NYSE: JNJ) today released new findings that show most women know menopause can affect mood and sleep, but fewer than half realize their eye health may change too. A new global survey of 6,000 women found that only 40% connect eye changes with the menopause transition—even though 90% say seeing clearly and comfortably helps them feel confident, capable or like themselves.i This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001236330/en/During Menopause Awareness Month, Johnson & Johnson is continuing its collaboration with Academy Award–nominated actress, entrepreneur and menopause advocate, Naomi Watts. During Menopause Awareness Month, Johnson & Johnson is continuing its collaboration with Academy Award–nominated actress, entrepreneur and menopause advocate, Naomi Watts. The American Optometric Association (AOA) is supporting the effort to encourage women to recognize eye and vision changes and speak with an eye care professional. “We’re talking more openly about menopause, but eye health is still too often left out,” said Naomi Watts, founder of Stripes Beauty. “I want women to know they don’t have to quietly work around changes like dry eyes or blurry vision. An eye exam is a simple step that can help them understand their eye health options and feel more in control.” A common—but often overlooked—midlife change The new survey, conducted across the United States, United Kingdom, Brazil, South Korea, Japan and China, points to a clear awareness gap. While 75% of women have taken action to manage changes associated with midlife, only 18% have booked an annual eye exam as part of that routine. The survey also found: 66% have experienced dry, gritty or irritated eyes, and 60% have experienced blurred vision. Only 18% have discussed these changes with an eye care professional. Among women who have not sought help for vision changes, 31% have used a phone flashlight to read a menu or relied on other workarounds, such as enlarging text or holding reading material farther away. “Too many women are simply adapting to midlife vision changes without realizing there are solutions available,” said Dr. Charissa Lee, Head of Professional Affairs, Vision, MedTech, Johnson & Johnson. “By making eye health part of the menopause conversation, we can help women find the options that support clear, comfortable vision and everyday confidence.” Midlife vision changes can happen at the same time as the menopause transition and its possible eye health changes. Symptoms may include dry or irritated eyes, blurry near vision, headaches, or needing to hold reading material farther away.ii A comprehensive eye exam can help identify what is changing and which options, like multifocal contact lenses, may better support the patient’s lifestyle. Turning awareness into action Watts will continue sharing her eye health journey and encouraging women to include vision in their midlife wellness routine. The AOA will encourage women to make comprehensive eye exams part of their midlife health care and provide doctors of optometry with resources to support conversations about eye and vision changes and available care options during menopause. "Eye and vision health needs to be part of the broader health conversation as women navigate menopause," said Teri K. Geist, O.D., AOA President.iii "A comprehensive eye exam and an open dialogue with your doctor of optometry can help women understand the changes they may be experiencing, identify eye health concerns they may not notice on their own and get the care they need to see and feel their best." Three simple steps for women: Notice changes: Pay attention to dryness, irritation, blurry near vision, headaches or growing reliance on workarounds. Book a comprehensive eye exam: Don’t wait until vision changes interfere with daily life. An annual in-person comprehensive exam is an important part of overall health care and can assess eye and vision health and help identify appropriate solutions. Start the conversation: Tell an eye care professional about menopause-related health changes and how vision is affecting work, reading, driving or other daily activities. Women can learn more, take a lifestyle quiz and find a local eye doctor nearby by visiting the Vision Made Possible website. *Disclosure: This is a paid endorsement. Naomi Watts was compensated for this quote. About Vision at Johnson & Johnson Johnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients’ eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech and on LinkedIn. About the Study Ipsos conducted the survey on behalf of Johnson & Johnson from July 31 to August 6, 2026, among 6,000 women ages 35–60 in the United States, United Kingdom, Brazil, South Korea, Japan and China. Quotas and weighting were used to reflect each market’s population. Results for the full sample are accurate within ±1.5 percentage points, and results for each country sample of 1,000 women are accurate within ±3.8 percentage points, 19 times out of 20. i Johnson & Johnson. Vision Made Possible International Survey. August 2026.
ii Presbyopia. Cleveland Clinic. (2023, July 6). https://my.clevelandclinic.org/health/diseases/8577-presbyopia
iii Teri K. Geist, O.D., serves as President of the American Optometric Association (AOA), which is supporting this Johnson & Johnson effort. Dr. Geist has not been compensated in connection with this press release. 2026PP16998 View source version on businesswire.com: https://www.businesswire.com/news/home/20261001236330/en/ Media Contacts:
Michelle Parker
MParker5@its.jnj.com Erin Farley
Efarley1@its.jnj.com Investor Contact:
Investor-relations@its.jnj.com Original: New Global Survey by Johnson & Johnson Finds Most Women Don’t Connect Eye Health Changes with Menopause

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Johnson & Johnson presents new data reinforcing sustained disease control and improved daily function achieved with IMAAVY® (nipocalimab-aahu) in generalized myasthenia gravis (gMG) New two-year findings from the Phase 2/3 long-term extension demonstrate sustained disease control through two years, improvement in daily function and muscle strength, and reductions in corticosteroid use in anti-AChR+a adolescentsRetrospective survey in adults identified fluctuating symptom control as a top driver for discontinuing prior advanced treatment, with most patient outcomes improving after transitioning to IMAAVY Data among 15 novel abstracts on IMAAVY to be presented at the MGFA Scientific Session during AANEM 2026SPRING HOUSE, Pa., Sept. 29, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new findings on IMAAVY® (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG) across 15 novel abstracts to be presented at the 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. These data include two-year results from the Phase 2/3 study in adolescents which demonstrated sustained disease control while on IMAAVY, with patients maintaining improvements in daily function and muscle strength alongside reductions in corticosteroid use.1 In addition, a retrospective survey of healthcare professionals (HCPs) treating adults with anti-AChRa or anti-MuSKb antibody-positive gMG provides insight into how fluctuating symptoms and the resulting unmet need for more sustained disease control can drive transitions from one advanced therapy to another.2 Long-term data demonstrated sustained disease control in adolescents with gMGTwo-year findings from the Vibrance-MG Phase 2/3 long-term extension study showed sustained disease control in adolescents living with anti-AChR+ gMG alongside continued reductions in corticosteroid use. These findings are consistent with improvements observed in adults in the open-label extension of the Phase 3 Vivacity-MG3 study:1Daily function and muscle strength improvements were sustained through Week 108: Among participants with available data, mean changes from baseline were -2.88 points in MG-ADLc and -8.25 points in QMGd at Week 108 consistent with findings at Week 4, 24 and at all intervening time points through two years.Corticosteroid reductions were observed: Of the six adolescent patients taking corticosteroids at study entry, three reduced their dose while one discontinued after two years on IMAAVY.No new safety signals were identified through up to two years of treatment: The safety profile of IMAAVY in adolescents was similar to that reported in adults."For adolescents living with generalized myasthenia gravis, unpredictable muscle weakness and symptoms such as eyelid droop and double vision can affect more than physical health; they can disrupt school, friendships and their growing independence," said Jonathan Strober, M.D., Director, Pediatric Neuromuscular Program and Neuromuscular Clinic Sponsored by the MDA.e "The two-year Vibrance-MG results are encouraging and add to our growing body of evidence of IMAAVY in adolescents with continued improvements in daily function, muscle strength and reductions in corticosteroid use observed over time."Need for sustained disease control drives treatment transitionsFindings from a retrospective surveyf of HCPs treating adults with anti-AChR+ or anti-MuSK+ gMG highlight how the need for more sustained disease control can shape treatment decisions—from dissatisfaction with fluctuating symptoms on a prior advanced therapy, to seeking improved efficacy and a consistent treatment schedule when initiating IMAAVY:2Fluctuating symptom control was the most common driver for discontinuing prior therapy: HCPs cited fluctuating symptom control (54.6%) suggesting that a lack of sustained disease control remains an important unmet need shaping treatment decisions.Consistent treatment schedule and hope for improved efficacy were the top drivers for initiating IMAAVY: Among 97 patients who transitioned from prior advanced therapies to IMAAVY, HCPs most frequently cited preference for a consistent treatment schedule (62.9%) and hope for improved efficacy (56.7%) as reasons for initiating IMAAVY.Positive outcomes reported following transition to IMAAVY: HCPs reported that 73.2% of patients were "much improved" or "very much improved," while 76.4% of patients receiving prednisone reduced their dose and 5.5% discontinued use—an important treatment objective for people living with gMG."People living with generalized myasthenia gravis can experience fluctuating symptoms that make sustained disease control an important treatment goal. The HCP survey findings provide important insight into the factors shaping treatment decisions, with fluctuating symptom control emerging as the leading reason healthcare professionals reported for discontinuing prior therapy," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The broader clinical evidence for IMAAVY across adolescents and adults, including reductions in corticosteroid use, further informs our understanding of the potential for IMAAVY to deliver sustained disease control across a broad population of people living with gMG."IMAAVY is an immunoselective treatment designed to substantially reduce pathogenic immunoglobulin G (IgG), a root cause of gMG, while preserving B-cell function. It is currently the only FcRn blocker approved for pediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody-positive gMG by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).3,4Editor's notes:a. Anti-AChR+ = anti-acetylcholine receptor positive antibody.
b. Anti-MuSK+ = anti-muscle specific tyrosine kinase positive antibody.
c. MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.5
d. QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicate greater disease severity.6
e. Dr. Jonathan Strober has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.
f. The treatment-switch findings are based on a retrospective, 21-item electronic survey of U.S. neurology HCPs. Eligible HCPs had switched at least one adult with gMG from a prior advanced therapy such as IVIG, an anti-CD19 therapy, complement inhibitor or other FcRn inhibitor; respondents reviewed medical records and reported de-identified data from 97 patients. As findings relied on HCP reporting and retrospective medical record review, they may be subject to information and recall bias. The convenience sample of HCPs may also limit generalizability to broader clinical settings and patient populations, while the cross-sectional design does not allow conclusions about long-term trends or causal relationships.About generalized myasthenia gravis (gMG)Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.7,8 The disease impacts an estimated 700,000 people worldwide.9 The disease affects both men and women and occurs across all ages and racial and ethnic groups, but it most frequently starts in young women and older men.10 Roughly 50% of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.10,11,12 Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.12,13,14,15 Among juvenile MG patients, girls are affected more often than boys, with over 65% of pediatric MG cases in the U.S. diagnosed in girls.16,17,18Initial disease manifestations are usually eye-related, but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG).19,20,21,22,23,24 This is characterized by severe muscle weakness and difficulties in speech and swallowing.20,21,22,23,24 Approximately 100,000 individuals in the U.S. are living with gMG.25 Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.26About the Phase 2/3 Vibrance-MG study The Phase 2/3 Vibrance-MG study (NCT05265273) is an ongoing open-label study to determine the effect of nipocalimab in pediatric participants with gMG.27 Seven participants aged 12-17 years with a diagnosis of gMG as reflected by a Myasthenia Gravis Foundation of America (MGFA) Class of II through IV at screening, and an insufficient clinical response to ongoing, stable SOC therapy, have been enrolled in the trial.28 Participants must have a positive blood test for either anti-AChR or anti-MuSK autoantibodies.28 The study consists of a screening period of up to four weeks, a 24-week open-label active-treatment phase during which participants receive nipocalimab intravenously every two weeks, and a long-term extension phase; a safety follow-up assessment will be conducted at eight weeks after last dose.28 The primary endpoint of the study is the effect of nipocalimab on total serum IgG, safety and tolerability, and pharmacokinetics in pediatric participants with gMG at 24 weeks. Secondary endpoints include change in MG-ADL and QMG scores at 24 weeks.28,29About IMAAVY® (nipocalimab-aahu)IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving B-cell function based on in vitro and/or in vivo studies.29,30,31 IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.4 IMAAVY is also approved for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.4Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.32,33,34,35,36,37,38,39,40,41 The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN, and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026The legal manufacturer for IMAAVY is Janssen Biotech, Inc.IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMAAVY?IMAAVY is a prescription medicine that may cause serious side effects, including:Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you have any of the following infection symptoms: feverchillsshiveringcough sore throatfever blistersburning when you urinatetrouble breathingAllergic (hypersensitivity) reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or throattrouble swallowing or breathing hivesitchy rashchest pain or tightnessInfusion-related reactions. Tell your healthcare provider right away if you get any of these symptoms during or within a few days after your IMAAVY infusion: headacherashnauseafatigue dizzinesschillsflu-like symptomsredness of skinDo not receive IMAAVY if you have a history of a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis. Refer to the Patient Information section of the Prescribing Information for a complete list of ingredients in IMAAVY.Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:have had an allergic reaction to IMAAVY.have or had any recent infections or symptoms of infection.have or had shingles (herpes zoster) or mono (mononucleosis caused by Epstein-Barr virus).have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.are pregnant or plan to become pregnant. It is not known if IMAAVY will harm your unborn baby.Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY. If IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY, your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736.are breastfeeding or plan to breastfeed. IMAAVY can pass into your breast milk. It is not known if IMAAVY will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with IMAAVY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of IMAAVY?IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"The most common side effects in people with gMG treated with IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.The most common side effects in people with wAIHA treated with IMAAVY include: peripheral edema (swelling in your hands, ankles, or feet), diarrhea, and pyrexia (fever).These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see the full Prescribing Information and Patient Information for IMAAVY and discuss any questions you have with your doctor.Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.Follow us at @JNJInnovMed.  Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.REFERENCES1 Vu T, et al. Two year follow-up results of nipocalimab in adolescents with Generalized myasthenia gravis during active-treatment and Long-term extension phases: vibrance-mg phase 2/3 study. Presented at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session. Poster #25.
2 Kutz C, et al. Retrospective Review of Treatment Switches to Nipocalimab in Generalized Myasthenia Gravis: Real-World Healthcare Provider Perspectives. Presented at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session. Poster #55.
3 IMAAVY® U.S. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761430s000lbl.pdf. Last accessed: September 2026.
4 European Medicines Agency. IMAAVY® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/imaavy-epar-product-information_en.pdf. Last accessed: September 2026
5 Wolfe GI. Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. 
6 Yin, J et al. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024;31(8):e16322.
7 Bacci, ED et al. Understanding side effects of therapy for myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335.
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11 Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021.
12 J&J. Data on file.
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18 Mansukhani SA, et al. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr; 200:242-249.
19 Law, N et al. The Lived Experience of Myasthenia Gravis: A Patient-Led Analysis. Neurol Ther. 2021;10(2):1103-1125.
20 National Institute of Neurological Disorders and Stroke. Myasthenia Gravis. Available at: https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis Last accessed: September 2026.
21 Bever, CT et al. (1983), Prognosis of ocular myasthenia. Ann Neurol. 1983;14(5):516-9. 
22 Kupersmith, MJ et al. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003;60(2):243-8. 
23 National Institute of Neurological Disorders and Stroke. Myasthenia gravis fact sheet. Available at: https://www.ninds.nih.gov/sites/default/files/migrate-documents/myasthenia_gravis_e_march_2020_508c.pdf. Last accessed: September 2026.
24 Cleveland Clinic. Myasthenia Gravis: Treatment & Symptoms. Available at: https://my.clevelandclinic.org/health/diseases/17252-myasthenia-gravis-mg. Last accessed: September 2026.
25 DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020.
26 O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. 
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28 Strober J et al. Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
29 Seth, N et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025;17(1):2461191
30 Zhu, LN et al. FcRn inhibitors: a novel option for the treatment of myasthenia gravis. Neural Regen Res. 2023;18(8):1637-1644.
31 Ling, LE et al. M281, an anti-fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first-in-human study. Clinical Pharmacology & Therapeutics. 2018;105(4):1031–1039.
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Bridget Kimmel bkimmel@its.jnj.com  
Investor contact: 
Jessica Margevichinvestor-relations@its.jnj.com  
  View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-presents-new-data-reinforcing-sustained-disease-control-and-improved-daily-function-achieved-with-imaavy-nipocalimab-aahu-in-generalized-myasthenia-gravis-gmg-302892849.htmlSOURCE Johnson & Johnson Innovative Medicine Original: Johnson & Johnson presents new data reinforcing sustained disease control and improved daily function achieved with IMAAVY® (nipocalimab-aahu) in generalized myasthenia gravis (gMG)

Johnson & Johnson announces TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study Topline results show TREMFYA met the primary and major secondary endpoints of axial involvement in PsA - including spinal pain and stiffness - and demonstrated significant improvement in MRI-confirmed inflammationFirst-ever study to use objective MRI assessments to confirm presence of axial involvement and demonstrate axial inflammation reduction in PsASPRING HOUSE, Pa., Sept. 25, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that TREMFYA® (guselkumab) met the primary and major secondary endpoints demonstrating both improvement in axial symptoms and reduction in inflammation by MRI assessment in the Phase 4 STAR study evaluating biologic-naïve adults with active psoriatic arthritis and axial involvement (axial PsA). STAR is the first and only dedicated randomized, double-blind, placebo-controlled study of its kind designed to prospectively evaluate an IL-23 inhibitor specifically in patients with axial involvement confirmed by magnetic resonance imaging (MRI).1 These topline findings represent an important milestone in advancing disease-specific evidence for patients living with axial PsA. Detailed efficacy and safety results, including MRI findings, will be presented at an upcoming scientific congress. In the STAR study, TREMFYA met the primary endpoint evaluating improvement in a composite patient-reported disease activity score that includes spinal pain, stiffness, fatigue, joint symptoms and areas of tenderness (the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])a at Week 24 versus placebo. TREMFYA also met major secondary endpoints demonstrating a significant reduction in both axial symptoms, as measured by ASDAS-CRPb, and objective (MRI) inflammation of the sacroiliac joints. The overall safety profile observed in the STAR study was consistent with the established safety profile of TREMFYA in PsA, and no new safety signals were identified.1"Axial PsA involves inflammation of the spine and sacroiliac joints, often leading to debilitating pain, stiffness, and fatigue. Patients face reduced mobility and a diminished quality of life, underscoring the urgent need for a treatment that helps stop further joint damage and targets the underlying disease," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "As the first Phase 4 study of an IL-23 inhibitor in this patient population, STAR further strengthens the growing body of evidence supporting TREMFYA as a first-line treatment option proven to help stop further joint damage."Advancing the evidence in psoriatic arthritis with axial involvementAxial involvement is a clinical domain of PsA in which inflammation affects the spine and sacroiliac joints.2 It can cause back pain, morning stiffness, fatigue, impaired mobility and reduced physical function, and is associated with poorer quality of life than PsA without axial involvement.3 Axial involvement may affect approximately 5 to 28 percent of patients with early PsA and 25 to 70 percent of those with longer-standing disease.4Despite advances in treating PsA, axial involvement remains an area of significant unmet need. There are currently no universally accepted classification criteria specific to axial PsA,5 and very few prospective clinical trials have been dedicated specifically to this patient population. Building on the growing body of evidence supporting TREMFYA in psoriatic arthritis"Clinical data continue to expand the evidence base for TREMFYA effectiveness across multiple domains of psoriatic arthritis," said Philip J. Mease, M.D., MACR, FRCP, Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine in Seattle, WA.c "What makes the STAR study particularly noteworthy is that, for the first time in a prospective, randomized, double-blinded, placebo-controlled PsA study, it evaluates MRI assessments for inclusion and provides a rigorous and objective measure of improvements in inflammation alongside clinical outcomes in axial PsA. Together, these findings contribute to a more comprehensive understanding of disease activity and treatment effects."Johnson & Johnson recently received U.S. Food and Drug Administration (FDA) approval of a label expansion for the inhibition of progression of structural joint damage in adults with active PsA, cementing TREMFYA as the only IL-23 inhibitor proven to help stop further joint damage.TREMFYA is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis. Findings are based on in vitro studies.6,7,8,9,10Editor's notes:a. BASDAI is a validated patient-reported outcome (PRO) originally developed to measure disease activity on a 0 to 10 scale in ankylosing spondylitis (AS), now referred to as radiographic axial spondyloarthritis (r-axSpA).11
b. ASDAS-CRP, or Ankylosing Spondylitis Disease Activity Score with C-Reactive Protein, is a validated, composite index that combines patient-reported symptoms with a laboratory biomarker to objectively measure inflammation and disease severity.12,13
c. Dr. Philip Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.About the STAR study (NCT04929210)STAR is a Phase 4, multicenter, randomized, double-blind, placebo-controlled study evaluating TREMFYA in biologic-naïve adults with active psoriatic arthritis (PsA) and axial involvement. Eligible participants had active PsA with objective evidence of axial inflammation confirmed by centrally read MRI and elevated C-reactive protein despite previous treatment with non-biologic disease-modifying antirheumatic drugs (DMARDs), apremilast and/or nonsteroidal anti-inflammatory drugs (NSAIDs).14The study enrolled 411 participants worldwide and includes a 24-week placebo-controlled treatment period followed by a 24-week active treatment period. The primary endpoint evaluated change from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24. Secondary endpoints include additional assessments of axial symptoms, MRI inflammation, physical function, peripheral musculoskeletal manifestations, skin disease and safety.14About psoriatic arthritis with axial involvement Psoriatic arthritis with axial involvement (axial PsA) is a chronic inflammatory condition where psoriatic arthritis affects the spine and sacroiliac joints (connecting the lower spine to the pelvis). It can cause inflammatory back pain, neck stiffness, and reduced mobility, in addition to the joint, skin or nail manifestations commonly associated with PsA.15,16Despite significant advances in the treatment of psoriatic arthritis, axial involvement remains an area of substantial ongoing need and research.7 While it shares some clinical features with axial spondyloarthritis (axSpA), axial involvement is increasingly recognized as a distinct domain of psoriatic arthritis.4 However, there is currently no universally accepted definition or validated classification criteria specific to PsA with axial involvement, and prospective studies conducted exclusively in patients with axial involvement remain very limited.5 About TREMFYA (guselkumab)Developed by Johnson & Johnson, TREMFYA is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.TREMFYA is a prescription medicine approved in the U.S. to treat:adults and children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).adults and children six years and older who also weigh at least 40 kg with active psoriatic arthritis.adults with moderately to severely active ulcerative colitis.adults with moderately to severely active Crohn's disease.TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis.The manufacturer for TREMFYA is Janssen Biotech, Inc. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit: www.tremfya.com.IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about TREMFYA?TREMFYA is a prescription medicine that may cause serious side effects, including:Serious Allergic Reactions. Stop using TREMFYA and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:o fainting, dizziness, feeling lightheaded
(low blood pressure)o swelling of your face, eyelids, lips,
mouth, tongue or throato trouble breathing or throat tightnesso chest tightnesso skin rash, hiveso itchingInfections. TREMFYA may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA and may treat you for TB before you begin treatment with TREMFYA if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA.Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:o fever, sweats, or chillso muscle acheso weight losso cougho warm, red, or painful skin or sores on
your body different from your psoriasiso diarrhea or stomach paino shortness of breatho blood in your phlegm (mucus)o burning when you urinate or urinating
more often than normalLiver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:o unexplained rasho vomitingo tiredness (fatigue)o yellowing of the skin or
the whites of your eyeso nauseao stomach pain (abdominal)o loss of appetiteo dark urineDo not use TREMFYA if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA.Before using TREMFYA, tell your healthcare provider about all of your medical conditions, including if you:have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA?"have an infection that does not go away or that keeps coming back.have TB or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA. Children should be brought up to date with all vaccines before starting TREMFYAare pregnant or plan to become pregnant. It is not known if TREMFYA can harm your unborn baby.
Pregnancy Registry: If you become pregnant during treatment with TREMFYA, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA during pregnancy.are breastfeeding or plan to breastfeed. It is not known if TREMFYA passes into your breast milk.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of TREMFYA?TREMFYA may cause serious side effects. See "What is the most important information I should know about TREMFYA?"The most common side effects of TREMFYA include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, bronchitis feeling very tired (fatigue), fever (pyrexia), and skin rash.These are not all the possible side effects of TREMFYA. Call your doctor for medical advice about side effects.Use TREMFYA exactly as your healthcare provider tells you to use it.Please read the full Prescribing Information, including Medication Guide, for TREMFYA and discuss any questions that you have with your doctor.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Dosage Forms and Strengths: TREMFYA is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com Follow us at @JNJInnovMed. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related TREMFYA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.REFERENCES1 Data on file.
2 Poddubnyy D, Jadon DR, Van den Bosch F, Mease PJ, Gladman DD. Axial involvement in psoriatic arthritis: an update for rheumatologists. Semin Arthritis Rheum. 2021;51(4):880-887. Accessed July 2026.
3 Mease PJ, Palmer JB, Liu M, et al. Influence of Axial Involvement on Clinical Characteristics of Psoriatic Arthritis: Analysis from the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. The Journal of Rheumatology. 2018;45(10):1389-1396.
https://www.jrheum.org/content/45/10/1389. Accessed July 2026.
4 Feld J, Chandran V, Haroon N, Inman R, Gladman DD. Axial disease in psoriatic arthritis and ankylosing spondylitis: a critical comparison. Nature Reviews Rheumatology. 2018;14(6):363–371. doi:10.1038/s41584-018-0006-8.
5 Helliwell PS. Axial involvement in psoriatic arthritis: is it unique? Rheumatology. 2024;63(Supplement_2):ii15-ii19. doi:10.1093/rheumatology/keae558. Accessed July 2026.
6 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.
7 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
8 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
9 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.
10 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
11 Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994;21(12):2286-2291.
12 van der Heijde D, Lie E, Kvien TK, et al. ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Annals of the Rheumatic Diseases. 2009;68(12):1811-1818. doi:10.1136/ard.2008.094870.
13 Eder L et al. Is ASDAS better than BASDAI as a measure of disease activity in axial psoriatic arthritis?. Ann Rheum Dis. 2010;69(12):2160-2164. doi:10.1136/ard.2010.129726
14 ClinicalTrials.gov. A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease (STAR). Identifier: NCT04929210. Available at: https://clinicaltrials.gov/study/NCT04929210. Accessed September 2026.
15 Lopez-Medina C, Ziade N. Axial Disease in Psoriatic Arthritis: how can we Define it, and does it have an Impact on Treatment? Mediterranean Journal of Rheumatology. 2022;33(Suppl 1):142-149. doi:10.31138/mjr.33.1.142. PMID: 36127925; PMCID: PMC9450188. Accessed August 2026.
16 Gottlieb AB, Merola JF. Axial psoriatic arthritis: An update for dermatologists. Journal of the American Academy of Dermatology. 2021;84(1):92-101. doi:10.1016/j.jaad.2020.05.089. PMID: 32747079. Access August 2026. Media contact: 
Camilia Aberra
caberra@its.jnj.com 
Investor contact:
Jessica Margevich
investor-relations@its.jnj.com   View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-announces-tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-show-significant-improvement-in-spinal-pain-and-stiffness-in-landmark-axial-psoriatic-arthritis-psa-study-302889998.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson announces TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study

Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma New results suggest earlier treatment may increase the likelihood of long-term remissionStudy adds to Johnson & Johnson's overwhelming body of evidence supporting its innovative multiple myeloma therapies in second line, where earlier intervention may increase long-term remission and disease controlRARITAN, N.J., Sept. 25, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced today new long-term follow-up data from the initial subgroup of cohort A in the Phase 2 CARTITUDE-2 study (N=20) showing that 50% of patients (10/20) in early line relapsed or refractory multiple myeloma (RRMM) who were treated with a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) remained alive and progression-free for at least five years without maintenance therapy.1 These results build on the durable, treatment-free remissions observed in the CARTITUDE-1 study, which evaluated patients in later lines of therapy, and reinforce that earlier treatment with CARVYKTI® may increase long-term remission and disease control. Together, these findings add to the emerging evidence suggesting that CARVYKTI® may have curative potential in some patients.  Findings were presented at the International Myeloma Society (IMS) Annual Meeting (Abstract #PA-288).Expert and company perspectives on earlier treatment-free remissions with CARVYKTI®
"Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory multiple myeloma," said Niels van de Donk, M.D., Ph.D., Professor of Hematology, University Medical Center, Amsterdam, the Netherlands.* "These new CARVYKTI findings provide additional evidence that when highly effective, established therapies are used earlier in the disease course, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance.""These results add to the growing body of evidence suggesting that CARVYKTI may have curative potential for some patients, and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "As we continue to advance a portfolio of complementary and combinable therapies, these findings reinforce our commitment to pursuing curative approaches and redefining what patients can expect from multiple myeloma treatment."Phase 2 CARTITUDE-2 study build on previous findings
CARTITUDE-2 cohort A (N=20) enrolled patients with RRMM who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.1 The primary endpoint was minimal residual disease (MRD) negativity.1 Patients from initial cohort A were followed to assess long-term outcomes following a single CARVYKTI® infusion without maintenance therapy.1At a median follow-up of 60.7 months:Half of the patients (n=10, 50%) remained alive and progression-free at five yearsThe five-year overall survival rate was 69.2%Median progression-free survival was 60.5 monthsPatients received a single CARVYKTI® infusion without maintenance therapyAt five years, MRD was assessed by bone marrow in three patients and was not required per protocol.1 All three patients were MRD-negative at the deepest level tested (10-6), indicating no detectable disease using highly sensitive testing methods.1Long-term remissions were observed even among patients with high-risk disease features.1 Of the 10 patients who remained alive and progression-free at five years, five had at least one high-risk cytogenetic abnormality, including four patients with two or more high-risk features.1The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI®, with no new CAR T-cell-related neurotoxicity reported.1 Since the previous analysis, one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer.1About CARTITUDE-2
CARTITUDE-2 (NCT04133636) is an ongoing, multicohort Phase 2 study evaluating the efficacy and safety of ciltacabtagene autoleucel (CARVYKTI®) in patients in different clinical settings, including patients with one to three prior lines of therapy, and continues to generate long-term follow-up data on depth and durability of response. CARTITUDE-2 findings have been presented at major medical congresses, including the International Myeloma Society (IMS) Annual Meeting, and contribute to the growing body of evidence supporting earlier use of CARVYKTI® in multiple myeloma.About multiple myeloma 
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.3 Multiple myeloma is the third most common blood cancer worldwide.4 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.5 People living with multiple myeloma have a 5-year survival rate of 59.8%.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.7,8 In recent years, potential overall survival has improved from years to decades for some patients, with effective treatment options now available across every stage and line of therapy.9About Johnson & Johnson's multiple myeloma portfolio 
Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies. Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses. Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured. About CARVYKTI®
CARVYKTI® (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.10In April 2024, CARVYKTI® was approved in the U.S. for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide, following a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication. In April 2024, the European Medicines Agency (EMA) approved a Type II variation for CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma in patients that have no history of CAR-positive T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In July 2026, CARVYKTI® obtained a label expansion in Japan, allowing its use in patients with relapsed or refractory multiple myeloma who have received at least on prior therapy.CARVYKTI® is a BCMA-directed, autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI® CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells. CARVYKTI® is available in 17 markets worldwide and has been used to treat more than 13,000 patients globally.In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®. For more information, visit www.CARVYKTI.com. CARVYKTI® Important Safety InformationWARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed. Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®. Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life threatening reactions, occurred following treatment with CARVYKTI®. Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®.WARNINGS AND PRECAUTIONS Increased early mortality. In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®.Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.Neurologic toxicities, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%). Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms.Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.Guillain-Barré syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.Immune mediated myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.Peripheral neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.Cranial nerve palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®.HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion.Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.Infections: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI® infusion.Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.Hypogammaglobulinemia can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG

New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma Analysis shows ~87% of patients treated with TECVAYLI® plus DARZALEX FASPRO® as early as second line were estimated to have comparable mortality risk to the general populationA separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality Johnson & Johnson is advancing a differentiated multiple myeloma portfolio designed to deliver deeper, more durable disease control and improve long-term outcomes for patients RARITAN, N.J., Sept. 23, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy.1,2 Using a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from the trial, statistical modeling estimated that ~87% of patients treated with TECVAYLI® plus DARZALEX FASPRO® (Tec-Dara) may experience a mortality risk and projected life expectancy similar to an age-matched general population.1 Modeling further predicted that median overall survival with Tec-Dara would be nearly four-fold longer than with the standard of care (SOC) comparator in the study, dexamethasone with pomalidomide or bortezomib (DPd/DVd). These data help to illustrate to what extent treatment with TECVAYLI® plus DARZALEX FASPRO® as early as second line may reshape survival expectations in multiple myeloma.1In the MajesTEC-3 study, TECVAYLI® plus DARZALEX FASPRO® significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years.3 A post hoc analysis showed that Tec-Dara reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms.2 These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting.Expert and company perspectives emphasize the potential for durable, long-term disease control"These findings underscore how consequential treatment choice at first relapse can be in shaping a patient's long-term trajectory," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* "The sustained disease control observed with TECVAYLI plus DARZALEX FASPRO is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control." "The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable." Model-based analysis projects potential long-term survival outcomes The MajesTEC-3 study evaluated TECVAYLI® plus DARZALEX FASPRO® versus investigator's choice of daratumumab SC plus DPd/DVd in patients with RRMM who had received one to three prior lines of therapy.3 In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI® plus DARZALEX FASPRO® (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population.1 Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% CI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates.1 Model projected remaining life expectancy was 18.5 years with the combination, nearly four times the 4.9 years projected with DPd/DVd and approaching 21.1 years for the matched general population.1Reduced disease progression drives survival benefitA separate post hoc analysis provided further insight into the survival benefit observed in MajesTEC-3.2 At 36 months, the cumulative incidence of disease progression was 8.7% with TECVAYLI® plus DARZALEX FASPRO®, versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (subdistribution hazard ratio [sHR]=0.10; 95% CI, 0.07–0.16; P400 mg/dL.Neutropenia - TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients.Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines.Monitor patients with neutropenia for signs of infection.Withhold TECVAYLI based on severity.Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions.Systemic Reactions - In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic administration reactions, which included recurrent pyrexia and rash.Local Reactions - In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%.Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose.ADVERSE REACTIONS The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased.The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI.DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONSDARZALEX® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapyIn combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with bortezomib and dexamethasone in patients who have received at least one prior therapyIn combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyIn combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI)As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agentDARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapyIn combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyIn combination with bortezomib and dexamethasone in patients who have received at least one prior therapyAs monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agentIMPORTANT SAFETY INFORMATIONDARZALEX® ANDDARZALEX FASPRO®: CONTRAINDICATIONS
DARZALEX® and DARZALEX FASPRO® are contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase (for DARZALEX FASPRO®), or any of the components of the formulations.WARNINGS AND PRECAUTIONS
DARZALEX®: Infusion-Related Reactions
DARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma.Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision.When DARZALEX® dosing was interrupted in the setting of autologous stem cell transplant (ASCT) (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: 1%) injection-site reactions were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.DARZALEX® and DARZALEX FASPRO®: Infections
DARZALEX® and DARZALEX FASPRO® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX® in a pooled safety population (N=2066), serious infections, including opportunistic infections, occurred in 22.6% of patients, Grade 3 or 4 infections occurred in 24.3%, and fatal infections occurred in 1.2%. The most common (≥2%) types of serious infection reported were pneumonia (11%), upper respiratory tract infection (4%), sepsis (3%), and bronchitis (2%). In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%).Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX® or DARZALEX FASPRO® and treat appropriately. Administer prophylactic antimicrobials according to guidelines.DARZALEX® and DARZALEX FASPRO®: Neutropenia and Thrombocytopenia
DARZALEX® and DARZALEX FASPRO® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX® or DARZALEX FASPRO® until recovery of neutrophils or for recovery of platelets.In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.DARZALEX® and DARZALEX FASPRO®: Interference With Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX® and DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX® and DARZALEX FASPRO®.DARZALEX® and DARZALEX FASPRO®: Interference With Determination of Complete Response
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.DARZALEX® and DARZALEX FASPRO®: Embryo-Fetal Toxicity
Based on the mechanism of action, DARZALEX® and DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX® and DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX® or DARZALEX FASPRO® and for 3 months after the last dose.The combination of DARZALEX® or DARZALEX FASPRO® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.DARZALEX®: ADVERSE REACTIONS
The most frequently reported adverse reactions (incidence ≥20%) with DARZALEX® were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX® are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.DARZALEX FASPRO®: ADVERSE REACTIONS
In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, sleep disorder, headache, rash, renal impairment, motor dysfunction, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, decreased appetite, urinary tract infection, abdominal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, dizziness, bruising, and COVID-19.The most common hematologic laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.Please click here to read full Prescribing Information for DARZALEX®.
Please click here to read full Prescribing Information for DARZALEX FASPRO®.About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our?expertise?in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of?tomorrow, and?profoundly?impact?health for humanity. Learn more at?https://www.jnj.com/?or at?www.innovativemedicine.jnj.com. Follow us at?@JNJInnovMed. Caution Concerning Forward-Looking Statements
This press release?contains?"forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to?TECVAYLI®?(teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties?materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at?www.sec.gov,?www.jnj.com,?www.investor.jnj.com?or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement?as a result of?new information?or future events or developments. Footnote






*Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.





























1 Effelterre T, et al. Projecting Functional Cure in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) in the MajesTEC-3 Study of Teclistamab-Daratumumab (Tec-Dara) Using a Mixture Cure Model. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 23, 2026; Glasgow, Sweden.






2 Costa L, et al. Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 24, 2026; Glasgow, Sweden.






3 MajesTEC-3, NCT05083169. A Phase 3 Randomized Study Comparing Teclistamab + Subcutaneous Daratumumab (Tec-Dara) Versus Daratumumab SC + Pomalidomide + Dexamethasone (DPd) or Daratumumab SC + Bortezomib + Dexamethasone (DVd). https://clinicaltrials.gov/study/NCT05083169. Accessed September 2026






4 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-567.






5 National Cancer Institute. Plasma cell neoplasms. Accessed September 2026.?https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq






6 City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026.?https://www.cancercenter.com/cancer-types/multiple-myeloma






7 International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026.?https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf






8 SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026.?https://seer.cancer.gov/explorer/ 






9 American Cancer Society. What is multiple myeloma? Accessed September 2026.?https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html 






10 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026.?https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html






11 Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy.?J Clin Oncol.?2018;36(15):1479-1487.?https://pmc.ncbi.nlm.nih.gov/articles/PMC6119139/






12 Johnson & Johnson. U.S. FDA approves TECVAYLI®?(teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. Accessed September 2026.?https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma






13 DARZALEX FASPRO®?U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc.






14 DARZALEX®?U.S. Prescribing Information. 2022. Horsham, PA: Janssen Biotech, Inc.






  View original content to download multimedia:https://www.prnewswire.com/news-releases/new-model-based-analysis-further-supports-the-potential-of-tecvayli-teclistamab-cqyv-plus-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-to-redefine-long-term-survival-expectations-in-early-line-relapsedrefractory-multi-302887782.htmlSOURCE Johnson & Johnson Original: New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma

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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026September 14, 2026 11:00 PM
PR Newswire (US) Low rates of rash, blood clots and administration-related reactions were observed with subcutaneous treatment and prophylaxisFewer than 1% of patients discontinued treatment due to treatment-related events at one yearNew findings from Johnson & Johnson build on the MARIPOSA survival benefit and strengthen evidence for RYBREVANT FASPRO plus LAZCLUZE as first-line treatmentSEOUL, South Korea, Sept. 14, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new results from the Phase 2b COPERNICUS study evaluating how subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib), with less frequent dosing and prophylactic strategies, can improve the treatment experience for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations. Early results show consistently low rates across key treatment-related events and treatment discontinuation.1 COPERNICUS was designed to reflect everyday clinical practice, enrolling a racially and ethnically diverse patient population across both academic and community sites. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) (Abstract #M012.09).1RYBREVANT FASPRO dual-targets EGFR and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system.2,3,4,5 It is approved across multiple EGFR-mutated advanced NSCLC treatment settings and, for eligible patients, offers once-monthly dosing following initial weekly dosing.6Advancing the treatment experience with RYBREVANT-based regimens"RYBREVANT plus LAZCLUZE has already shown that patients with EGFR-mutated lung cancer can live longer, and these latest results mark an important evolution in the treatment approach," said Balazs Halmos, M.D., M.S., Director of Thoracic Oncology and Associate Director of Clinical Science, Montefiore Einstein Comprehensive Cancer Center. "With subcutaneous administration, less frequent dosing and prophylactic strategies, the regimen has been developed with the treatment experience in mind, helping patients start treatment and stay on it.""Our work with RYBREVANT in EGFR-mutated lung cancer has continued to evolve with each new piece of evidence, from extending survival to advancing how treatment is delivered and managed," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "COPERNICUS brings those learnings together in a study designed around the realities of clinical care. It reflects our commitment to continually innovate across the treatment journey so that scientific advances can make a meaningful difference for more patients."Detailed study resultsIn this analysis, 214 U.S. patients received the recently approved RYBREVANT FASPRO plus LAZCLUZE regimen with prophylactic strategies to reduce the risk of blood clots with oral anticoagulation and skin-related side effects with an enhanced, easy-to-use skin care regimen evaluated in the COCOON study.1,7At a median follow-up of 8.3 months, the majority of adverse events were Grade 1 or 2, with no new safety signals observed. Only eight percent of patients discontinued treatment due to adverse events. Rash was reported in 25 percent of patients, while administration-related reactions (ARRs) and venous thromboembolism (VTE) were each reported in three percent. No patients discontinued due to ARRs, and one percent discontinued due to rash and VTE.1These findings represent lower numerical rates than observed with intravenous RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE in the Phase 3 MARIPOSA study, where rash, ARRs and VTE during the first four months of treatment were reported in 55 percent, 55 percent and 23 percent of patients, respectively. MARIPOSA also demonstrated that patients with advanced EGFR-mutated advanced NSCLC treated with the first-line regimen lived longer than those treated with osimertinib, with a statistically significant overall survival benefit (hazard ratio [HR], 0.75; P=0.005).8COPERNICUS is one of the largest global studies conducted in patients with EGFR-mutated NSCLC, with a target enrollment of 300 previously untreated patients. Of the population reported here, median age was 67 years, 22 percent were age 75 or older, 27 percent were Asian, 10 percent were African American and 10 percent were Hispanic/Latino.1This study reflects Johnson & Johnson's continued focus on improving the treatment experience for people with cancer, including how treatments are delivered and managed in everyday care.About the COPERNICUS studyCOPERNICUS (NCT06667076) is a Phase 2b, single-arm study evaluating RYBREVANT FASPRO plus LAZCLUZE with prophylactic strategies in patients with EGFR-mutated advanced non-small cell lung cancer. Cohort 1 evaluates the regimen in the first-line setting, incorporating once-every-four-weeks dosing, venous thromboembolism (VTE) and enhanced dermatologic prophylaxis.The study uses a pragmatic design to more closely reflect real-world clinical practice, with participation from academic and community sites and reduced visit frequency. The primary endpoint is investigator-assessed progression-free survival per RECIST v1.1. Secondary endpoints include safety and tolerability measures, including VTE and dermatologic adverse events and administration-related reactions, as well as overall survival and overall response rate.9About non-small cell lung cancerWorldwide, lung cancer is one of the most common cancers, with non-small cell lung cancer (NSCLC) making up 80 to 85 percent of all lung cancer cases.10,11 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.12 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.13 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.10,11,14,15,16,17 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.18 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.19,20 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.21 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.22About RYBREVANT FASPRO and RYBREVANTRYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 23 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ ||The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.INDICATIONSRYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT 6,24CONTRAINDICATIONSRYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.Infusion-Related Reactions with RYBREVANTRYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.RYBREVANT with LAZCLUZEIn MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.RYBREVANT as a Single AgentIn CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.RYBREVANT with LAZCLUZEIn MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.RYBREVANT as a Single AgentIn CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZERYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).RYBREVANT with LAZCLUZEIn MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.Dermatologic Adverse ReactionsRYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.RYBREVANT with LAZCLUZEIn MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.RYBREVANT as a Single AgentIn CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severityHepatotoxicityLAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).RYBREVANT with LAZCLUZEIn MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.Ocular ToxicityRYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.RYBREVANT with LAZCLUZEIn MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.RYBREVANT as a Single AgentIn CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.Embryo-Fetal ToxicityBased on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.ADVERSE REACTIONSRYBREVANT FASPRO with LAZCLUZEIn PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).RYBREVANT with LAZCLUZEIn MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).RYBREVANT with Carboplatin and PemetrexedIn MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO, RYBREVANT and LAZCLUZE.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.* Balazs Halmos, M.D., M.S., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.† RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well
solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.‡ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.§ See the NCCN Guidelines for detailed recommendations, including other treatment options.|| The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.Source: Johnson & Johnson


1 Halmos B, et al. Subcutaneous amivantamab + lazertinib with supportive care in EGFR-mutant NSCLC: Longer follow-up from the pragmatic COPERNICUS study. Presented at: IASLC 2026 World Conference on Lung Cancer; 2026; Seoul.2 Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-28333 Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-00714 Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-01165 Soo R, et al. Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.6 RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 7 Cho BC, Li W, Spira AI, et al. Enhanced versus standard dermatologic management with amivantamab-lazertinib in EGFR-mutated advanced NSCLC: the COCOON global randomized controlled trial. J Thorac Oncol. 2025;20(10):1517-1530. doi:10.1016/j.jtho.2025.07.117.8 Yang JCH, Lu S, Hayashi H, et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. N Engl J Med. 2025;393(17):1681-1693. doi:10.1056/NEJMoa2503001.9 ClinicalTrials.gov. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS). Accessed September 2026. https://clinicaltrials.gov/study/NCT0666707610 The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed September 2026.11 American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed September 2026.12 Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.13 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.14 Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 2019;37(2):97-104.15 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.16 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.17 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.18 American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed September 2026.19 Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.20 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.21 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.22 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.23 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed September 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.24 RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.com  Investor contact:
Jess Margevich 
investor-relations@its.jnj.com  U.S. Medical Inquiries: +1 800 526-7736    View original content to download multimedia:https://www.prnewswire.com/news-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-plus-lazcluze-lazertinib-with-prophylactic-strategies-shows-low-rates-of-treatment-related-events-at-wclc-2026-302878165.htmlSOURCE Johnson & Johnson Original: RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE® (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026

Johnson & Johnson Shares Rise on Reported Apollo Talks for Orthopedics UnitSeptember 14, 2026 9:31 AM
IH Market News Johnson & Johnson (NYSE:JNJ) shares rose 1.3% to $268.96 in pre-market trading on Monday following a report that Apollo Global Management (NYSE:APO) is in discussions to acquire the healthcare group’s orthopedics business. Bloomberg News reported on Friday that a potential transaction could value the division at close to $20 billion, citing people familiar with the matter. According to the report, an agreement could be reached within several weeks. No transaction was confirmed in the supplied information. Orthopedics Unit Generated $9.3 Billion in 2025 Johnson & Johnson’s orthopedics division generated $9.3 billion in revenue in 2025. The business has also faced thousands of lawsuits relating to its hip replacement devices. Johnson & Johnson shares moved higher in pre-market trading as investors assessed the reported discussions and the potential value of a transaction involving the orthopedics unit. Johnson & Johnson stock price Apollo Global Management stock priceThe post Johnson & Johnson Shares Rise on Reported Apollo Talks for Orthopedics Unit appeared first on US Editors. Original: Johnson & Johnson Shares Rise on Reported Apollo Talks for Orthopedics Unit

Johnson & Johnson's RYBREVANT® (amivantamab-vmjw) plus chemotherapy delivers longest reported median overall survival in EGFR exon 20 insertion mutation-positive lung cancerSeptember 13, 2026 9:45 PM
PR Newswire (US) RYBREVANT plus chemotherapy demonstrates durable benefit with a differentiated approach that dual-targets EGFR and METResults mark significant progress for a patient population with poor outcomes and a historical five-year survival rate of just 8%SEOUL, South Korea, Sept. 13, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from the final overall survival (OS) analysis of the Phase 3 PAPILLON study evaluating first-line intravenous (IV) RYBREVANT (amivantamab-vmjw) plus carboplatin-pemetrexed chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Ex20ins) mutations. Patients treated with the combination achieved a median OS of nearly three years (34.3 months), compared with 27.9 months for chemotherapy alone. The combination extended median OS by more than six months, despite 76 percent of eligible patients in the chemotherapy arm crossing over to second-line RYBREVANT after disease progression. This represents the longest reported median OS in this patient population, which is nearly twice the historical median.1 These results were presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) (Late-breaking Abstract #PL.03.03).Resetting survival expectations for patients with historically poor outcomesEGFR exon 20 insertion mutations account for approximately 12 percent of all EGFR mutations.2 Unlike more common EGFR mutations (exon 19 deletions and L858R), exon 20 insertion mutations have been difficult to treat with targeted medicines, leaving patients with few treatment options, challenging side effects and poorer outcomes.3 Historically, median overall survival has ranged from approximately 16 to 24 months, with five-year survival reported at just eight percent.4,5,6RYBREVANT is a first-in-class bispecific antibody designed to dual-target EGFR and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system.7,8,9,10 It is currently approved for use in patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, in the first- and second-line settings.11Expert and company perspectives on longer survival in historically difficult-to-treat lung cancer"We've come a long way in treating EGFR exon 20 insertion-positive lung cancer, and these results demonstrate the lasting impact RYBREVANT plus chemotherapy can have in helping patients live longer," said Dr. Chul Kim, M.D., M.P.H.,* Director of Thoracic Oncology, MedStar Georgetown University Hospital. "Patients are continuing treatment years after they started, which speaks to the durability of this approach and its value as a first-line treatment for this disease.""We have long believed RYBREVANT could transform the outlook for patients with EGFR-mutated lung cancer by addressing key drivers of disease progression and treatment resistance," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "With the longest survival seen in this patient population, these results add to the growing body of evidence across common, atypical and exon 20 insertion EGFR mutations and further establish the regimen as a backbone therapy."Detailed overall survival results      In the protocol-specified final analysis, RYBREVANT plus chemotherapy demonstrated a median OS of nearly three years (34.3 months) compared to approximately two years (27.9 months) for chemotherapy alone (hazard ratio [HR], 0.87; 95 percent confidence interval [CI], 0.66-1.14; P=0.307). A prespecified analysis accounting for crossover to RYBREVANT in the chemotherapy arm showed a significant overall survival benefit with RYBREVANT plus chemotherapy, reducing the risk of death by 43 percent (HR, 0.57; 95 percent CI, 0.39-0.82; nominal P=0.003).1Long-term follow-up provides further evidence of durable benefit, with RYBREVANT plus chemotherapy extending progression-free survival through second disease progression (PFS2) by more than 10 months compared with chemotherapy alone (28.3 vs. 17.5 months; HR, 0.59; 95 percent CI, 0.45-0.77; nominal P2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO, RYBREVANT and LAZCLUZE.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT® (amivantamab-vmjw). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.* Dr. Chul Kim, M.D., M.P.H., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.† RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well
solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.‡ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.§ See the NCCN Guidelines for detailed recommendations, including other treatment options.|| The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.Source: Johnson & Johnson


1Kim C, et al. First-line amivantamab-chemotherapy vs chemotherapy in NSCLC with EGFR exon 20 insertions: Overall survival from PAPILLON. Presented at: IASLC 2026 World Conference on Lung Cancer; 2026; Seoul.2Arcila ME, Nafa K, Chaft JE, et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity and clinicopathologic characteristics. Molecular Cancer Therapeutics. 2013;12(2):220-229.3Brazel D, et al. Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options. BioDrugs. 2022 Nov;36(6):717-729. doi: 10.1007/s40259-022-00556-4.4Ou SI, et al. Real-world response and outcomes in patients with NSCLC with EGFR exon 20 insertion mutations. JTO Clin Res Rep. 2023;4(10):100558.5Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer. 2021;162:154–1616Chouaid C, et al. A real-world study of patients with advanced non-squamous non-small cell lung cancer with EGFR exon 20 insertion: clinical characteristics and outcomes. Target Oncol. 2021;16(6):801-811.7Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-28338Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc enhanced EGFR/cMet bispecific antibody, induces receptor downmodulation and antitumor activity by monocyte/macrophage trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-00719Yun J, Lee SH, Kim SY, et al. Antitumor activity of amivantamab (JNJ-61186372), an EGFR-MET bispecific antibody, in diverse models of EGFR exon 20 insertion-driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-011610Soo R, et al. Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.11RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.12Zhou C, Tang KJ, Cho BC, et al; PAPILLON Investigators. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med. 2023;389(22):2039-2051. doi:10.1056/NEJMoa2306441.13ClinicalTrials.gov. A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON). https://clinicaltrials.gov/ct2/show/NCT04538664. Accessed September 2026.14The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed September 2026.15American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed September 2026.16Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.17Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. 2021 World Conference on Lung Cancer Annual Meeting; January 29, 2021.18Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 37:97-104.19Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.20Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.21Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.22American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed September 2026.23Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.24Lin JJ, et al. Five-year survival in EGFR-mutant metastatic lung adenocarcinoma treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.25Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.26Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed September 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.27RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.com  Investor contact:
Jess Margevich 
investor-relations@its.jnj.com  U.S. Medical Inquiries: +1 800 526-7736    View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnsons-rybrevant-amivantamab-vmjw-plus-chemotherapy-delivers-longest-reported-median-overall-survival-in-egfr-exon-20-insertion-mutation-positive-lung-cancer-302877002.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson's RYBREVANT® (amivantamab-vmjw) plus chemotherapy delivers longest reported median overall survival in EGFR exon 20 insertion mutation-positive lung cancer

Johnson & Johnson Receives CE Marking for ACUVUE OASYS MAX Reusable Contact LensesSeptember 10, 2026 7:45 AM
Business Wire New 2-week reusable contact lens brings advanced ACUVUE OASYS MAX technologies to deliver superior comfort and visual clarity to patients, even at day 14*†1 Expands the ACUVUE OASYS MAX portfolio with an advanced option for reusable contact lens wearers Designed to meet the growing demand for lasting comfort and clear vision in today’s screen-intensive world *†1 Johnson & Johnson (NYSE: JNJ) today announced that it has received CE Marking for ACUVUE OASYS MAX 2-Week,*** a new reusable contact lens featuring proprietary MAX technologies designed to deliver superior comfort and visual clarity, even at day 14.*†i¥1 The lens will be rolled out in select European countries later this year with wider market rollout in 2027. Globally, 140 million people wear contact lenses, with one in two choosing a reusable lens,2 and comfort remains their leading priority.3 With the continued rise in everyday use of digital devices and exposure to blue-violet light, more demands are being placed on patients’ eyes, often leading to reduced visual clarity and symptoms of dryness.4,5,6,7 ACUVUE OASYS MAX 2-Week brings Johnson & Johnson’s advanced MAX contact lens technologies to reusable contact lens wearers, helping address their evolving vision, comfort, and digital lifestyle needs. “People who choose reusable contact lenses should not have to compromise on comfort or clarity as their days get busier and their eyes work harder,” said Jacqueline Henderson, Company Group Chair, Vision, MedTech, Johnson & Johnson. “With ACUVUE OASYS MAX 2-Week, we are bringing our most advanced ACUVUE technologies to a reusable lens, helping more people see clearly and feel comfortable throughout the full two-week wear cycle.” ACUVUE OASYS MAX 2-Week combines Johnson & Johnson’s Eye-Inspired Designs††8 with advanced MAX technologies to deliver comfort and visual clarity throughout the 2-week wear cycle.±9 Key features include: OptiBlue Light Filter: Filters at least 60% of blue-violet light, the highest among reusable contact lenses.?**10 TearStable Technology: Helps eyes feel comfortable throughout the day by locking in moisture.11 Class 1 UV blocking^: In each lens helps shield the eyes from harmful radiation including the sun. These combined technologies provide clearer vision whether you’re working on screens,§ outdoors§§ or driving at night.§12 For eye care professionals, ACUVUE OASYS MAX 2-Week is designed to offer a familiar fitting experience for existing ACUVUE OASYS 2-Week wearers, with the same fitting process and no additional chair time.13 In clinical testing, 99% of subjects wearing ACUVUE OASYS 2-Week were successfully refit into ACUVUE OASYS MAX 2-Week with the same power, base curve and diameter.14,15 ACUVUE OASYS MAX 2-Week is the newest addition to the ACUVUE OASYS MAX portfolio of contact lenses and aims to give the reusable market an advanced option. The lens is expected to launch through a phased rollout beginning in select European markets in late 2026, with broader market expansion planned throughout 2027 and 2028, subject to local regulatory approvals and market readiness. ACUVUE OASYS MAX 2-Week Contact Lens has received CE Marking for European markets. It is not approved by the U.S. Food and Drug Administration and is not available for sale in the United States at this time. Important Safety Information: ACUVUE Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Contact lenses should not be used in case of eye infections or any other eye conditions, or in case of a systemic disease that may affect the eye. For detailed product information, including contraindications, precautions and adverse reactions, please consult the Instructions for Use available on Johnson & Johnson website www.e-ifu.com For any additional information, please visit our Johnson & Johnson website https://www.jnjvisionpro.co.uk. ^WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE: Long-term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-blocking contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information. ? Filtering of HEV light by contact lenses has not been demonstrated to confer any systemic and/or ocular health benefit to the user. The Eye Care Professional should be consulted for more information. About Vision at Johnson & Johnson Johnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients’ eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at JJVision.com, follow Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech on LinkedIn. ACUVUE is a Johnson & Johnson company. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to ACUVUE OASYS MAX 2-Week. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Vs. ACUVUE OASYS 2-Week
† Meta-analysis of 4 clinical studies (n=788).
¥ Measured on day 14
** Amongst publicly available information for standard daily wear, reusable soft contact lenses as of June 2026
‡Moisture retention calculated from pervaporation measurements
? Moisture Retention Index calculated from pervaporation measurements
††Does not apply to ACUVUE Abiliti Overnight
±Based on Top-2-Box descriptive summaries at 1-week and 2-week, n=101
§Vs ACUVUE® OASYS 2-WEEK
§§Top 2 box descriptive summaries, n=429
*** ACUVUE OASYS MAX now available in the reusable (2-week frequent replacement) modality 1 JJV Data on file, 2026
2 Morgan, P. B., et al. (2024). International trends in daily disposable contact lens prescribing (2000–2023): An update. Contact Lens and Anterior Eye, 47(6), Article 102259. https://doi.org/10.1016/j.clae.2024.102259
3 JJV Data on File 2026 AOMAX Claims: Market Leadership in Reusable Contact Lens Segment_2026
4 Tsubota K, Nakamori K. Dry eyes and video display terminals. N Engl J Med. 1993;328(8):584. doi: 10.1056/NEJM199302253280817.
5 Patel S, Henderson R, Bradley L, et al. Effect of visual display unit use on blink rate and tear stability. Optom Vis Sci 1991;68(11):888-892. doi: 10.1097/00006324-199111000-00010.
6 JJV Data on File 2022. Blue-Violet Filter Utilized in ACUVUE OASYS MAX 1-Day Contact Lenses
7 Nichols JJ, Willcox MDP, Bron AJ, et al. The TFOS International Workshop on Contact Lens Discomfort: Executive Summary. Invest Ophthalmol Vis Sci. 2013, 54:TFOS7-TFOS13.
8 JJV Data on File 2020. ACUVUE Brand - Eye-Inspired Innovations JJV Data on file, 2026
9 JJV Data on File. Clinical Performance Claims for ACUVUE® OASYS 2-Week
10 JJV Date on File: Technical Description of ACUVUE® OASYS MAX (2 Weeks) Family
11 JJV Data on File: ACUVUE OASYS MAX Families (Daily Disposable and Reusable) of Contact Lenses Claims Relating to TearStable™ and OptiBlue™ Technologies
12 JJV Data on file, 2026
13 JJV Data on File 2026_ACUVUE® OASYS MAX 2-Week Smooth Upgrade
14 JJV Data on File 2026_ACUVUE OASYS MAX 2-Week Smooth Upgrade
15 JJV Data on file, 2026 Third party trademarks are the property of their respective owners. ©Johnson & Johnson and its affiliates 2026. All rights reserved. 2026PP15556 v2 View source version on businesswire.com: https://www.businesswire.com/news/home/20260910357172/en/ Media contact:
Bryony Cox
J&J | Communications
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investor-relations@its.jnj.com Original: Johnson & Johnson Receives CE Marking for ACUVUE OASYS MAX Reusable Contact Lenses

Johnson & Johnson spotlights new neuropsychiatry data across bipolar mania, depression and schizophrenia at Psych Congress 2026September 8, 2026 8:00 AM
PR Newswire (US) First presentation of pivotal Phase 3 CAPLYTA ® data in adults with bipolar mania underscores the asset's potential across mood disordersNew SPRAVATO ® analyses and schizophrenia research emphasize a focus on complex, high-burden neuropsychiatric conditionsTITUSVILLE, N.J., Sept. 8, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that 24 abstracts featuring clinical data and real-world evidence across the neuropsychiatry portfolio will be presented at the 2026 Psych Congress Annual Meeting (September 15-19, New Orleans, LA).Among the featured presentations are new pivotal Phase 3 data evaluating the efficacy and safety of CAPLYTA® (lumateperone) in bipolar mania, alongside additional CAPLYTA® data across bipolar depression and major depressive disorder that further reinforce the breadth of studies for the asset across mood disorders. Data evaluating the effect of SPRAVATO® (esketamine) CIII nasal spray on depressive symptoms such as anhedonia, and Phase 3 clinical trial data for seltorexant in major depressive disorder (MDD) with insomnia symptoms will also be presented. Together, the presentations reflect the Company's continued commitment to advancing research across mood disorders, with a focus on areas where patients and clinicians still face significant treatment challenges."People living with neuropsychiatric disorders often face complex, overlapping symptoms that can make identification, treatment selection and long-term management especially challenging," said Jane Tiller, MD, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson. "By advancing clinical and real-world evidence across our portfolio and pipeline, we aim to help move psychiatry forward so that clinicians can continue to make more informed decisions for the patients they serve."Psych Congress Annual Meeting highlights include:CAPLYTA® New data from a pivotal Phase 3 study investigating CAPLYTA® in the acute treatment of patients with manic episodes or manic episodes with mixed features associated with bipolar I disorder will be presented,1 alongside additional data evaluating adjunctive CAPLYTA® in MDD across depressive symptoms, remission, patient subgroups, and metabolic outcomes.2-8New real-world evidence study evaluating treatment patterns among patients with bipolar depression receiving CAPLYTA®, including dosing and duration in line with routine clinical practice.9SPRAVATO® New analyses examining real-world evidence on the impact of SPRAVATO® in treating anhedonia, a core symptom of depression associated with poorer treatment outcomes.10,11Long-acting Injectables (LAIs)Real-world studies evaluating schizophrenia-related hospitalizations in young dual-eligible patients prior to LAI initiation and subsequent risk of relapse, as well as treatment satisfaction with LAIs.12,13SeltorexantReal-world data providing insights into MDD with insomnia symptoms, including disease burden, patient management and treatment outcomes.14-16The full list of Johnson & Johnson data presentations at Psych Congress is available on JNJ.com. The Company will also support a variety of educational programs, in-booth presentations and training opportunities for attendees, including interactive visualizations of PRIDE LAI data, and the latest CAPLYTA® schizophrenia and network meta-analysis (NMA) findings.ABOUT BIPOLAR MANIA
Bipolar disorder affects an estimated 37 million people worldwide—approximately 1 in 200 individuals—with 4.4% of U.S. adults experiencing the condition in their lifetime.17,18 Mania, a key feature of Bipolar I disorder, is characterized by at least a week-long period of elevated or irritable mood and/or increased energy, as well as symptoms including grandiosity, decreased need for sleep, racing thoughts, distractibility, and risk-taking behavior.19 These noticeable behavioral changes often differ markedly from an individual's baseline and are frequently first recognized by those close to them. In severe cases, manic episodes may require hospitalization for safety and treatment.20ABOUT MAJOR DEPRESSIVE DISORDER (MDD)
MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people—or about 4 percent of the population.21,22,23 In 2023, approximately 22 million adults in the U.S. had at least one major depressive episode.24 While depression is typically treated with a "one-size-fits-all" approach, no two cases are the same. MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations. As a result, responses to treatment vary widely.25,26 Only 1 in 3 patients reach remission with their first antidepressant—and rates continue to decline further with each subsequent treatment, leaving many to spend years cycling through multiple treatments trying to find complete, sustained symptom relief.27 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.28Anhedonia, a loss of interest or pleasure in previously enjoyed activities, is one of two defining symptoms of a major depressive episode.29 Anhedonia is associated with poorer treatment outcomes, including lower remission rates, greater functional impairment, and higher suicide risk.30 Notably, 40-70% of people with MDD experience anhedonia.30MDD often includes sleep disturbances such as insomnia or hypersomnia, with approximately 60 percent of MDD patients experiencing clinically relevant insomnia symptoms despite being on an SSRI/SNRI.31 Disturbed sleep and insomnia symptoms have a significant impact on a patient's quality of life and exacerbate the risk of depressive relapse and suicide.32,33Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (TRD), which is often defined as inadequate response to two or more oral antidepressants that were administered at an adequate dose for an adequate duration.34,35 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.35 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.36 Based on the STAR*D study, after their third line of treatment, approximately 86 percent of patients do not achieve remission.36ABOUT SCHIZOPHRENIA
Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently treated.37 Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common.38 Evidence shows that the first three to five years after diagnosis — "the critical period" — from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.39,40 A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, is critical in delaying the time to relapse for adults with schizophrenia.41ABOUT CAPLYTA® (lumateperone)
CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults as an adjunctive therapy with antidepressants for major depressive disorder (MDD), schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, or as adjunctive therapy with lithium or valproate.While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors.A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for delayed time to relapse in schizophrenia was recently approved by the U.S. Food and Drug Administration. The medication is also being studied for other neuropsychiatric disorders. CAPLYTA® is not FDA-approved for these disorders.ABOUT SPRAVATO® (esketamine) CIII NASAL SPRAY
SPRAVATO® is approved by the U.S. Food and Drug Administration as monotherapy or in conjunction with an oral antidepressant for adults with MDD when they have inadequate response to at least two oral antidepressants (TRD) and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. It is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than traditional antidepressants by acting on a pathway in the brain that affects glutamate. The mechanism by which esketamine exerts its antidepressant effect is unknown. To date, SPRAVATO® has been approved in over 70 markets and administered to more than 250,000 patients worldwide.ABOUT J&J'S SCHIZOPHRENIA LONG-ACTING INJECTABLE (LAI) PORTFOLIO
Johnson & Johnson's portfolio of long-acting injectable (LAI) offerings for schizophrenia offers a varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available, including INVEGA SUSTENNA® (1-month paliperidone palmitate), INVEGA TRINZA® (3-month paliperidone palmitate), and INVEGA HAFYERA® (6-month paliperidone palmitate), all of which are administered in a clinical setting by a medical professional.42,43,44ABOUT SELTOREXANT
Seltorexant, an investigational first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant selectively antagonizes the orexin-2 receptors, potentially improving mood symptoms associated with depression and restoring sleep without next-day sedation.45 When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia and excessive cortisol release, which may contribute to depression.46,47 Seltorexant is the only investigational therapy under study for the treatment of MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby targeting the underlying biology that contributes to depression and insomnia symptoms.CAPLYTA® IMPORTANT SAFETY INFORMATIONWhat is CAPLYTA (lumateperone)?CAPLYTA® (lumateperone) is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children.IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about CAPLYTA? Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis.CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed.Report any changes in these symptoms to your healthcare provider immediately.• thoughts about suicide or dying     • acting aggressive, being angry or violent • panic attacks• new or worse depression • new or worse anxiety• new or worse irritability  • feeling very agitated or restless   • suicide attempts • acting on dangerous impulses• trouble sleeping• an extreme increase in activity and talking (mania)• other unusual changes in behavior or moodDo not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat).What are the possible side effects of CAPLYTA?CAPLYTA may cause serious side effects, including:Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.Neuroleptic malignant syndrome (NMS): high fever, confusion, changes in your breathing, heart rate, and blood pressure, stiff muscles, and increased sweating; these may be symptoms of a rare but potentially fatal condition. Contact your healthcare provider or go to the emergency room if you experience signs and symptoms of NMS.Uncontrolled body movements (tardive dyskinesia, TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking CAPLYTA. It may also occur after you stop taking CAPLYTA.Problems with your metabolism including high blood sugar, diabetes, increased fat (cholesterol and triglyceride) levels in your blood and weight gain. Your healthcare provider should check your blood sugar, fat levels, and weight before you start and during your treatment with CAPLYTA.Extremely high blood sugar levels can lead to coma or death. Call your healthcare provider if you have any of the following symptoms of high blood sugar: feeling very thirsty, hungry, sick to your stomach, needing to urinate more than usual, weak/tired, or confused, or your breath smells fruity.Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with CAPLYTA.Decreased blood pressure (orthostatic hypotension). You may feel lightheaded, dizzy, or faint when you rise too quickly from a sitting or lying position.Falls. CAPLYTA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause broken bones or other injuries.Seizures (convulsions).Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how CAPLYTA affects you, do not drive, operate heavy machinery, or do other dangerous activities.Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated while taking CAPLYTA.Difficulty swallowing that can cause food or liquid to get into the lungs.The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea.These are not all the possible side effects of CAPLYTA.Before taking CAPLYTA, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems.CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk.Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules.Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for CAPLYTA.cp-548761v3INVEGA SUSTENNA®, INVEGA TRINZA®, INVEGA HAFYERA® IMPORTANT SAFETY INFORMATION INDICATIONS INVEGA HAFYERA® (6-month paliperidone palmitate) is a prescription medicine given by injection every 6 months by a healthcare professional and used to treat schizophrenia. INVEGA HAFYERA® is used in adults who have been treated with either: INVEGA SUSTENNA® (paliperidone palmitate) a 1-time-each-month paliperidone palmitate extended-release injectable suspension for at least 4 months INVEGA TRINZA® (paliperidone palmitate) a 1-time-every-3-months paliperidone palmitate extended-release injectable suspension for at least 3 months INVEGA TRINZA® is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been adequately treated with INVEGA SUSTENNA® for at least 4 months. INVEGA SUSTENNA® is a prescription medicine given by injection by a healthcare professional.  INVEGA SUSTENNA® is used to treat schizophrenia in adults. IMPORTANT SAFETY INFORMATION What is the most important information I should know about INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®? INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. 
INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® are not for the treatment of people with dementia-related psychosis. Do not receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® ingredients. Before you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:   have had Neuroleptic Malignant Syndrome (NMS) have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have or have had low levels of potassium or magnesium in your blood have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) have or have had kidney or liver problems have diabetes or have a family history of diabetes have Parkinson's disease or a type of dementia called Lewy Body Dementia have had a low white blood cell count have had problems with dizziness or fainting or are being treated for high blood pressure have or have had seizures or epilepsy have any other medical conditions are pregnant or plan to become pregnant. It is not known if INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® will harm your unborn baby If you become pregnant while taking INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry. Infants born to women who are treated with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. are breastfeeding or plan to breastfeed. INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® 
can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® works. Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine. Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls. How will I receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? Follow your treatment schedule exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much you will receive and when you will receive it. What should I avoid while receiving INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® affects you. Avoid getting overheated or dehydrated.  INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: See "What is the most important information I should know about INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®?" stroke in elderly people (cerebrovascular problems) that can lead to death Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure. problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats. uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain. low blood pressure and fainting changes in your blood cell counts high level of prolactin in your blood (hyperprolactinemia). INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.  problems thinking clearly and moving your body seizures difficulty swallowing that can cause food or liquid to get into your lungs prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.  problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration. The most common side effects of INVEGA HAFYERA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088. General information about the safe and effective use of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.Do not use INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. You can ask your pharmacist or healthcare professional for information about INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals. For more information, go to www.invegahafyera.com, www.invegatrinza.com or www.invegasustenna.com or call 1-800-526-7736. Please click to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional. cp-256259v4SPRAVATO® IMPORTANT SAFETY INFORMATION What is SPRAVATO® (esketamine) CIII nasal spray? SPRAVATO® is a prescription medicine used:with or without an antidepressant taken by mouth, to treat adults with treatment-resistant depression (TRD)with an antidepressant taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actionsSPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.It is not known if SPRAVATO® is safe and effective in children. IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about SPRAVATO®? SPRAVATO® can cause serious side effects, including: Sedation, dissociation, and respiratory depression. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), breathing problems (respiratory depression and respiratory arrest)Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out. Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting. Abuse and misuse. There is a risk for abuse and misuse with SPRAVATO®, which may lead to physical and psychological dependence. Your healthcare provider should check you for signs of abuse, misuse, and dependence before and during treatment.Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction. SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, respiratory depression and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (such as medical offices and clinics) must be enrolled in the program.Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not for use in children.Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Tell your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:  thoughts about suicide or dying new or worse depression feeling very agitated or restless trouble sleeping (insomnia) acting aggressive, being angry or violent an extreme increase in activity and talking (mania)   suicide attempts new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood  Do not take SPRAVATO® if you: have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs) have an abnormal connection between your veins and arteries (arteriovenous malformation) have a history of bleeding in the brain are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®. If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®. Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you: have heart or brain problems, including: high blood pressure (hypertension) slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting history of heart attack history of stroke heart valve disease or heart failure history of brain injury or any condition where there is increased pressure in the brain have liver problems have ever had a condition called "psychosis" (see, feel, or hear things that are not there, or believe in things that are not true). are pregnant or plan to become pregnant. SPRAVATO® may harm your unborn baby. You should not take SPRAVATO® if you are pregnant. Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®. If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®. There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/. are breastfeeding or plan to breastfeed. SPRAVATO® passes into your breast milk. You should not breastfeed during treatment with SPRAVATO®. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking SPRAVATO® with certain medicines may cause side effects. Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How will I take SPRAVATO®? You will take SPRAVATO®  nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device. Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it. Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to. During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®. If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule. Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®. If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®. What should I avoid while taking SPRAVATO®? Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO®?" What are the possible side effects of SPRAVATO®? SPRAVATO® may cause serious side effects including: See "What is the most important information I should know about SPRAVATO®?" Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®. Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night. The most common side effects of SPRAVATO® include:  feeling disconnected from yourself, your thoughts, feelings and things around you dizziness nausea feeling sleepy spinning sensation decreased feeling of sensitivity (numbness)   feeling anxious lack of energy increased blood pressure vomiting feeling drunk headache feeling very happy or excited  If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day. These are not all the possible side effects of SPRAVATO®. Call your doctor for medical advice about side effects. You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider. cp-170363v4 About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.© Johnson & Johnson and its affiliates 2026. All rights reserved.Cautions Concerning Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to product development and the potential benefits and treatment impact of CAPLYTA® (lumateperone), SPRAVATO® (esketamine) CIII nasal spray, and seltorexant. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.References: Brown D, Chen C, Chen M, et al. Lumateperone Treatment for Manic Episodes or Manic Episodes With Mixed Features in Bipolar I Disorder: Results From a Double-Blind, Placebo-Controlled, Randomized, Phase 3 Trial. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Black D, Namjoshi M, Obando C, et al. Changes in Mean Total Score on the PHQ-9 Among Bipolar Depression Patients Treated with Lumateperone in the United States: An Electronic Health Records Study. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Chen C, Durgam S, Earley WR, et al. Adjunctive Lumateperone 42 mg Treatment in Major Depressive Disorder: A Pooled Analysis of Efficacy Across Patient-Reported Depression Symptoms. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Armas-Datorre J, Durgam S, Earley WR, et al. Lumateperone 42 mg in Major Depressive Disorder: Demographic and Clinical Subgroups Efficacy Analysis in a Phase 3 Randomized Placebo-Controlled Trial. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Bhagwagar Z, Chen C, Durgam S, et al. Lumateperone 42 mg in Patients With Major Depressive Disorder: Analysis of Remission in Short- and Long-Term Trials. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Dutheil S, Snyder G. Assessment of Lumateperone Partial Agonist Activity at Presynaptic Dopamine D2 Autoreceptors: Reversal of Haloperidol-Induced Tyrosine Hydroxylase Phosphorylation in Mouse Striatum. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Chepke C, Durgam S, Earley W, et al. Metabolic Profile of Adjunctive Lumateperone 42 mg in Major Depressive Disorder: A Pooled Analysis of 2 Randomized, Placebo-Controlled Trials. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Chen H, Namjoshi M, Wu E, et al. Total Cost per Remitter of Lumateperone Versus Cariprazine for the Treatment of Major Depressive Disorder in the United States. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Liu Z, Namjoshi M, Obando C, et al. Real-World Lumateperone Dosing Patterns and Treatment Duration in Bipolar Depression. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Chepke C, Fu DJ, Himedan M, et al. Montgomery-Åsberg Depression Rating Scale Anhedonia Factor Score Following Esketamine Nasal Spray Monotherapy in Adult Patients With Treatment-Resistant Depression: A Post Hoc Analysis. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Cutler AJ, Drzayich J, Fu DJ, et al. Esketamine Nasal Spray on Anhedonia and Functional Outcomes: Findings from the Ventura Real-World Evidence Study. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Benson C, Doshi J, Geng Z, et al. Association of Schizophrenia-Related Hospitalization Before Long-Acting Injectable Antipsychotic Initiation and Outcomes Among Young Dual Eligibles. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Citrome L, Cline F, Han J, et al. Treatment Satisfaction, Quality of Life, Satisfaction with Participation in Social Roles, and Caregiver Burden In Adults with Schizophrenia Treated with Paliperidone Palmitate Long-Acting Injectables. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Cambron-Mellott J, Dwibedi N, Hamilton J, et al. Incidence of cardiometabolic events among adults with major depressive disorder with and without insomnia symptoms: a real-world evidence study. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Benson C, Campbell A, Johnston K, et al. Association of Insomnia Symptoms in Major Depressive Disorder with Healthcare Resource Use and Cardiovascular and Metabolic Conditions - Analysis of National Health & Nutrition Examination Survey. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.Creel S, Hebert Z, Johnston K, et al. Understanding Insomnia Management in Major Depressive Disorder Through Patient-Provider Discourse. Psych Congress 2026 Annual Meeting; Sept. 15-19, 2026.World Health Organization. Bipolar disorder. September 2025. Accessed August 2026. https://www.who.int/news-room/fact-sheets/detail/bipolar-disorder  National Health Institute. Bipolar Disorder. Accessed August 2026. https://www.nimh.nih.gov/health/statistics/bipolar-disorder#part_2606Oliva V, Fico G, De Prisco M et al. Bipolar disorders: an update on critical aspects. Lancet Reg Health Eur. 2024;48. doi:10.1016/j.lanepe.2024.101135.Cleveland Clinic. Mania. April 2026. Accessed August 2026. https://my.clevelandclinic.org/health/diseases/21603-maniaWorld Health Organization. Mental disorders. Accessed May 2026. https://www.who.int/news-room/fact-sheets/detail/mental-disordersNational Alliance on Mental Health. Mental health by the numbers. Accessed May 2026. https://www.nami.org/mental-health-by-the-numbers/  World Health Organization. Depressive disorder (depression). Accessed October 2025. who.int/news-room/fact-sheets/detail/depressionKey substance use and mental health indicators in the United States: results from the 2023 national survey on drug use and health. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Published July 2024. Accessed May 2026. https://www.samhsa.gov/data/report/2023-nsduh-annual-national-reportSu YA and Si T. Progress and challenges in research of the mechanisms of anhedonia in major depressive disorder. Gen Psychiatr. 2022;35:e100724. doi:10.1136/gpsych-2021-10072  Pandya M, et al. Where in the Brain Is Depression? Curr Psychiatry Rep. 2012;14:634–642. doi:10.1007/s11920-012-0322-7Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi:10.1176/ajp.2006.163.Arnaud AM, Brister TS, Duckworth K, et al. Impact of major depressive disorder on comorbidities: a systematic literature review. J Clin Psychiatry. 2022;83(6):21r14328.Cao B, Zhu J, Zuckerman H, et al. Pharmacological interventions targeting anhedonia in patients with major depressive disorder: A systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2019;92:109–117. doi: 10.1016/j.pnpbp.2019.01.002Kale H, Ganz ML, Ghosh, R. Burden of prominent anhedonia in major depressive disorder reflected in polypharmacy, healthcare use and humanistic outcomes. Poster presentation at Psych Congress 2024, Boston, MA, United States.Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res. 2003;37(1):9-15. doi:10.1016/S0022-3956(02)00052-3Taddei-Allen P. Economic Burden and Managed Care Considerations for the Treatment of Insomnia. AJMC. Updated April 12, 2020. Accessed May 2026. https://www.ajmc.com/view/economic-burden-and-managed-care-considerations-for-the-treatment-of-insomnia Agargün MY, Kara H, Solmaz M. Sleep disturbances and suicidal behavior in patients with major depression. J Clin Psychiatry. 1997;58(6):249-51National Institute of Mental Health. Major Depression. Accessed May 2026. https://www.nimh.nih.gov/health/statistics/major-depressionZhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. 2021;82(2):20m13699. doi:10.4088/JCP.20m13699  Sanacora G, Zarate C, Krystal J, et al. Targeting the glutamatergic system to develop novel, improved therapeutics for mood disorders. Nat Rev Drug Discov. 2008;7(5):426-437. doi:10.1038/nrd2462Treatment Advocacy Center. Schizophrenia Fact Sheet. Accessed May 2026. www.tac.org/reports_publications/schizophrenia-fact-sheet/.Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/j.schres.2023.11.015Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand Journal of Psychiatry vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241National Alliance on Mental Illness. Understanding Schizophrenia. Accessed May 2026. https://www.nami.org/types-of-conditions/schizophrenia/Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125INVEGA SUSTENNA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.INVEGA TRINZA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.INVEGA HAFYERA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.Recourt K, de Boer P, Zuiker R, et al. The selective orexin-2 antagonist seltorexant (JNJ-42847922/MIN-202) shows antidepressant and sleep-promoting effects in patients with major depressive disorder [published correction appears in Transl Psychiatry. 2019 Oct 2;9(1):240. doi:10.1038/s41398-019-0585-4Nollet M, Leman S. Role of orexin in the pathophysiology of depression: potential for pharmacological intervention.?CNS Drugs. 2013;27(6):411-422. doi:10.1007/s40263-013-0064-z??Brooks S, Jacobs GE, de Boer P, et al. The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia. J Psychopharmacol. 2019;33(2):202-209. doi:10.1177/0269881118822258 View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-spotlights-new-neuropsychiatry-data-across-bipolar-mania-depression-and-schizophrenia-at-psych-congress-2026-302871765.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson spotlights new neuropsychiatry data across bipolar mania, depression and schizophrenia at Psych Congress 2026

Johnson & Johnson to Participate in the Deutsche Bank 2026 Healthcare SummitSeptember 2, 2026 4:21 PM
Business Wire Johnson & Johnson (NYSE: JNJ) will present at the Deutsche Bank 2026 Healthcare Summit on Thursday, September 17th, 2026. Management will participate in a Fireside Chat at 12:00 p.m. Eastern Time. A live audio webcast of the presentation will be accessible through Johnson & Johnson’s Investor Relations website at www.investor.jnj.com. An archived edition of the session will be available later that day. The audio webcast replay will be available approximately 48 hours after the webcast. View source version on businesswire.com: https://www.businesswire.com/news/home/20260902938660/en/ Media contact:
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investor-relations@its.jnj.com Original: Johnson & Johnson to Participate in the Deutsche Bank 2026 Healthcare Summit

Johnson & Johnson to Host Investor Conference Call on Third-Quarter ResultsAugust 31, 2026 5:08 PM
Business Wire Johnson & Johnson (NYSE: JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, October 13th to review third-quarter results. Joaquin Duato, Chairman and Chief Executive Officer, Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Ryan Koors, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include additional members of Johnson & Johnson’s executive team. Investors and other interested parties can access the webcast/conference call in the following ways: The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes. By telephone: for both “listen-only” participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261. A replay of the conference call will be available until approximately 12:00 a.m. on October 27th. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13762207. The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call. Please refer to www.investor.jnj.com for a complete list of currently planned earnings webcast/conference calls. Please note the fourth-quarter date of Tuesday, January 26th, 2027. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. View source version on businesswire.com: https://www.businesswire.com/news/home/20260831627428/en/ Media contact:
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investor-relations@its.jnj.com Original: Johnson & Johnson to Host Investor Conference Call on Third-Quarter Results

FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patientsAugust 24, 2026 7:12 PM
PR Newswire (US) IMAAVY is an immunoselective FcRn blocker designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell functionWarm autoimmune hemolytic anemia is a rare, life-threatening disease in which autoantibodies cause the destruction of red blood cells, leading to severe anemia and debilitating fatigueThe approval is based on the pivotal Phase 2/3 study which demonstrated durable hemoglobin responseaA mean increase in hemoglobin of 1 g/dL at Week 1b and improvement in FACIT-Fatiguec score at Week 24 were observed in IMAAVY-treated patientsdSPRING HOUSE, Pa., Aug. 24, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) approval of IMAAVY® (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. The approval, which follows FDA Priority Review, marks the first time a therapy was proven safe and effective specifically for the treatment of wAIHA.1 "Living with wAIHA often means relentless fatigue and the constant uncertainty of not knowing what tomorrow will bring," said Karen Jones, President and Executive Director, wAIHA Warriors.e "Patients may cycle through periods where they start to feel like themselves again — and then their hemoglobin drops, the exhaustion returns, and they're back to square one. For the first time, our community has a treatment specifically for our disease."Addressing serious unmet need in wAIHA In wAIHA, pathogenic immunoglobulin G (IgG) autoantibodies attach to and destroy red blood cells, causing severe anemia, profound fatigue, and a significantly increased risk of morbidity and mortality.2 Previously, available treatment options only included corticosteroids and immunosuppressants — therapies that suppress the entire immune system without specifically targeting the IgG autoantibodies driving the disease.3"The Phase 2/3 ENERGY study demonstrates that targeting pathogenic IgG can meaningfully change the treatment paradigm for wAIHA," said David Kuter, M.D., D.Phil., Distinguished Physician, Massachusetts General Hospital and Professor of Medicine at Harvard Medical School.f "More patients treated with IMAAVY achieved a durable hemoglobin response compared with placebo — meaning their red blood cell levels went up and stayed up. For patients, this approval means that they now have a therapy with a proven safety profile that targets the disease-driving autoantibodies in wAIHA."Clinical evidence summary of IMAAVY in wAIHAThe primary endpoint of the Phase 2/3 ENERGY study was durable hemoglobin (Hgb) response,a a stringent endpoint definition that reflects meaningful increases in Hgb levels over time.4,5 The randomized, placebo-controlled trial demonstrated approximately three times as many patients receiving the approved dose of IMAAVYg achieved durable Hgb levels versus placebo by 24 weeks.5,h Overall patients in this treatment group showed a mean increase in Hgb of 1g/dL at Week 1.5,b In addition, IMAAVY was associated with a 3.5-point higher mean FACIT-Fatiguec score versus placebo at Week 24, with higher scores defined as less fatigue.5,d In the ENERGY study IMAAVY demonstrated a safety profile consistent with the established safety profile of IMAAVY in generalized myasthenia gravis (gMG).4 The most common adverse reactions (≥10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea, and fever.5The full results of the ENERGY study were presented at the European Hematology Association 2026 meeting in June 2026.Building on a proven approach to autoantibody-driven disease"Today's announcement marks the second approval for IMAAVY and is an extraordinary milestone for people living with warm autoimmune hemolytic anemia, an underserved community that has waited far too long for an FDA-approved treatment," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "As the first therapy approved for wAIHA, IMAAVY has the potential to redefine the management of wAIHA, particularly for those with uncontrolled disease. This milestone reinforces our motivation to continue pursuing advanced therapies for people living with allo- and autoantibody diseases like wAIHA."IMAAVY was approved in the United States in April 2025 for the treatment of gMG in adult and pediatric patients 12 years of age and older who are acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive.5Johnson & Johnson is committed to helping patients access our treatments. Once a decision has been made to prescribe IMAAVY, the IMAAVY withMe patient support program provides personalized support including educational resources, a dedicated Nurse Navigator,i and cost support options – regardless of insurance type.Editor's Notes:a.   Durable hemoglobin (Hgb) response, the primary endpoint of the Phase 2/3 ENERGY trial, is defined as Hgb concentration ≥10 g/dL and an increase from baseline in Hgb ≥2 g/dL for at least 28 days  (where criteria was met starting by Week 16 of the double-blind period), without the need of rescue therapy5
b.   A mean increase of 1 g/dL in Hgb was observed at Week 1. Among the responders, the median time to first Hgb response was 4.1 (range: 1 to 12) weeks in patients treated with IMAAVY 30 mg/kg every 4 weeks, compared to 12.1 (range: 4 to 16) weeks in the placebo group. Results are considered descriptive based on the study's pre-specified statistical analysis plan6
c.   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
d.   Mean change from baseline of FACIT-Fatigue score at Week 24, a key secondary endpoint, with mean difference of 3.51 (95% CI: 0.64; 6.39) points in the IMAAVY 30 mg/kg IV treatment group compared to placebo.5 Results are considered descriptive based on the study's pre-specified statistical analysis plan6
e.   Karen Jones has not been compensated for any media work
f.   Dr. Kuter has served as a consultant to J&J; he has not been paid for any media work
g.   30 mg/kg q4w is the approved dose
h.   Durable Hgb response, as defined in Editor's note "a," was achieved with statistical significance in the approved 30 mg/kg IV q4w treatment group5
i .   Nurse Navigators do not provide medical adviceABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo, followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA).7 115 adults were randomized approximately 1:1:1 to receive nipocalimab at two different dose schedules or placebo.7 Following completion of 24 weeks of double-blind treatment, patients could enter an open-label extension period to receive nipocalimab for 144 weeks with a follow-up period of 6 weeks after last assessment.7ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia.8 Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.8,9 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.9,10 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.11ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving B-cell function based on in vitro and/or in vivo studies.12,13 IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.5 IMAAVY is also approved for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.5 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.14,15,16,17,18,19,20,21 The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:  EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN, and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024  U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026The legal manufacturer for IMAAVY is Janssen Biotech, Inc.IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMAAVY?
IMAAVY is a prescription medicine that may cause serious side effects, including:Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you have any of the following infection symptoms: feverchillsshiveringcough  sore throatfever blistersburning when you urinatetrouble breathing Allergic (hypersensitivity) reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or
throattrouble swallowing or breathing  hivesitchy rashchest pain or tightness Infusion-related reactions. Tell your healthcare provider right away if you get any of these symptoms during or within a few days after your IMAAVY infusion: headacherashnauseafatigue  dizzinesschillsflu-like symptomsredness of skin Do not receive IMAAVY if you have a history of a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis. Refer to the Patient Information section of the Prescribing Information for a complete list of ingredients in IMAAVY.Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:have had an allergic reaction to IMAAVY.have or had any recent infections or symptoms of infection.have or had shingles (herpes zoster) or mono (mononucleosis caused by Epstein-Barr virus).have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.are pregnant or plan to become pregnant. It is not known if IMAAVY will harm your unborn baby.
Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY. If IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY, your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736. are breastfeeding or plan to breastfeed. IMAAVY can pass into your breast milk. It is not known if IMAAVY will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with IMAAVY.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"The most common side effects in people with gMG treated with IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.The most common side effects in people with wAIHA treated with IMAAVY include: peripheral edema (swelling in your hands, ankles, or feet), diarrhea, and pyrexia (fever).These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see the full Prescribing Information and Patient Information for IMAAVY and discuss any questions you have with your doctor.Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.  Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.REFERENCES1 Johnson & Johnson. Press Release: FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA).  Available at: https://www.jnj.com/media-center/press-releases/fda-grants-priority-review-for-imaavy-nipocalimab-aahu-as-the-potential-first-approved-treatment-for-people-living-with-warm-autoimmune-hemolytic-anemia-waiha.  Last accessed: April 2026.
2 Rarediseases.org. Warm Autoimmune Hemolytic Anemia. Available at https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: February 2025.
3 Sudulagunta SR, et al. Warm Autoimmune Hemolytic Anemia: Clinical Profile and Management. J Hematol. 2017 Mar; 6(1): 12–20. Published online 2017 Mar 21. doi: 10.14740/jh303w.
4 Fattizzo B, Murakhovskaya I, Ueda.Y, Schlichting D, Sweet K, Zelasky M, Craig J, Liva S, Leu J, Ling L, Pease S, Anakor A, Shu C, Nipocalimab for warm autoimmune hemolytic anemia: results from the Phase 2/3 randomized, double-blind ENERGY study, Presented at EHA 2026 Congress, Available at:  https://library.ehaweb.org/eha/2026/eha-2026/4206854/bruno.fattizzo.nipocalimab.for.warm.autoimmune.hemolytic.anemia.results.from.html
5 IMAAVY® U.S. Prescribing Information.
6 J&J. Data on File.
7 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://www.clinicaltrials.gov/study/NCT04119050
8 National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: February 2025.
9 Tranekær S, Hansen DL, Frederiksen H. Epidemiology of Secondary Warm Autoimmune Haemolytic Anaemia-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi: 10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
10 Cherif, H., Cai, Q., Crivera, C., Leon, A., Rahman, I., Leval, A., Noel, W. and Kjellander, C. (2024), Overall Survival and Treatment Patterns Among Patients With Warm Autoimmune Hemolytic Anemia in Sweden: A Nationwide Population-based Study. Eur J Haematol.?https://doi.org/10.1111/ejh.14311.
11 Fattizzo B, Barcellini W. New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfusion Medical Reviews, Vol. 36, Issue 4. October 2022 https://doi.org/10.1016/j.tmrv.2022.08.001.
12 Ling LE., et al. M281, an anti-fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first-in-human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
13 Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
14 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: August 2026.
15 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: August 2026.
16 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: August 2026.
17 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: August 2026.
18 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: August 2026.
19 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: August 2026.
20 ClinicalTrials.gov Identifier: NCT06741969 Available at: https://clinicaltrials.gov/study/NCT06741969 Last accessed: August 2026.
21 ClinicalTrials.gov Identifier: NCT07438496 Available at: https://clinicaltrials.gov/study/NCT07438496 Last accessed: August 2026. View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-approves-imaavy-nipocalimab-aahu-as-first-ever-treatment-for-warm-autoimmune-hemolytic-anemia-waiha-representing-a-landmark-advancement-for-patients-302858778.htmlSOURCE Johnson & Johnson Original: FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients

imo... pharma is on fire~~~~~~~~~~~~~~~~~JNJ .....dumpster fire.






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imo.... the vax mobile storm crawler~~~~~~~~ OoooooooooO>





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imo... hey Vexari.... in your travels with politicians...have you EVER witnessed 5 childhood bloodd-infused "vaccinations" administered in a conastoga wagon....???????

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NO?


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Johnson & Johnson to Participate in the Morgan Stanley 24th Annual Global Healthcare ConferenceAugust 10, 2026 4:27 PM
Business Wire Johnson & Johnson (NYSE: JNJ) will present at the Morgan Stanley 24th Annual Global Healthcare Conference on Monday, September 14th, 2026. Management will participate in a Fireside Chat at 11:30 a.m. Eastern Time. A live audio webcast of the presentation will be accessible through Johnson & Johnson's Investor Relations website at www.investor.jnj.com. An archived edition of the session will be available later that day. The audio webcast replay will be available approximately 48 hours after the webcast. View source version on businesswire.com: https://www.businesswire.com/news/home/20260810189263/en/ Media contact:
media-relations@its.jnj.com Investor contact:
investor-relations@its.jnj.com Original: Johnson & Johnson to Participate in the Morgan Stanley 24th Annual Global Healthcare Conference

Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancerJuly 30, 2026 8:30 AM
PR Newswire (US) Priority Review reinforces the significant potential of subcutaneous amivantamab in recurrent or metastatic head and neck cancer, where the current five-year survival rate is only 15 percent Patients achieved rapid, deep and durable responses, including a 42 percent overall response rate with one-third achieving a complete response Subcutaneous amivantamab is the only therapy in head and neck cancer engineered to target both EGFR and MET, proven drivers of tumor growth and treatment resistance RARITAN, N.J., July 30, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately six months.1 "One of the hardest things about advanced head and neck cancer is that it can impact our most basic functions, like the ability to speak, eat, and even breathe easily, profoundly affecting patients' daily lives. For those whose disease progresses despite prior treatment, that burden is compounded by limited treatment options and poor outcomes," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "Building on the established role of subcutaneous amivantamab in lung cancer, this milestone underscores its continued potential across multiple tumor types and reflects our commitment to bringing innovative treatment options to patients with cancers driven by EGFR and MET pathways."Subcutaneous amivantamab was designed to target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) while engaging the immune system, offering a differentiated scientific approach in recurrent or metastatic head and neck squamous cell carcinoma.2 Overexpression of EGFR and MET receptors is seen in 80 to 90 percent of head and neck squamous cell carcinoma tumors and has been implicated in tumor progression and treatment resistance.3Priority Review supported by pivotal resultsThe FDA's decision to grant Priority Review is supported by results from the pivotal Phase 1b/2 OrigAMI-4 study, which showed that 42 percent of patients responded to treatment with monotherapy subcutaneous amivantamab, with more than one-third of responders achieving a complete response. The study excluded patients with oropharyngeal squamous cell carcinoma caused by human papillomavirus (HPV), as well as those who had received prior anti-EGFR therapy. The findings were presented at the 2026 American Society for Clinical Oncology (ASCO) and published simultaneously in the Journal of Clinical Oncology.4,5RYBREVANT FASPRO™ is approved in more than 40 countries, including the United States, Europe, and Japan, as a subcutaneous treatment for non-small cell lung cancer and continues to be evaluated in additional tumor types as part of Johnson & Johnson's broader commitment to advancing transformational oncology therapies.About the OrigAMI-4 StudyOrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes six cohorts exploring RYBREVANT FASPRO™ across different treatment settings and regimens.Cohort 1 evaluated RYBREVANT FASPRO™ as monotherapy in patients with R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Patients with HPV-positive oropharyngeal squamous cell carcinoma were excluded, as well as those with prior anti-EGFR therapy.RYBREVANT FASPRO™ was administered on a weekly schedule during the initial treatment period followed by dosing every three weeks (Q3W), with weight-based dosing adjustments. The primary endpoint across cohorts is overall response rate (ORR), as assessed by investigators, using RECIST v1.1.† 6About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinoma (HNSCC) is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity, and salivary glands.7 It represents approximately 4.5 percent of all cancers worldwide and is the seventh most common cancer globally.7 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).7 Approximately 80 percent of recurrent or metastatic HNSCC are not driven by HPV, and are typically associated with poorer prognosis and reduced response to treatment.7,8,9 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced recurrent or metastatic disease.10,11About RYBREVANT FASPRO™ and RYBREVANT®RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO™ offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.RYBREVANT FASPRO™ is approved in the U.S. for the same indications as intravenous RYBREVANT® (amivantamab-vmjw) across multiple markets. RYBREVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 12 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ ||The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.The legal manufacturer for RYBREVANT FASPRO™ and RYBREVANT® is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.INDICATIONSRYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT 13,14CONTRAINDICATIONSRYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.Infusion-Related Reactions with RYBREVANTRYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.RYBREVANT with LAZCLUZEIn MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.RYBREVANT as a Single AgentIn CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.RYBREVANT with LAZCLUZEIn MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.RYBREVANT as a Single AgentIn CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZERYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).RYBREVANT with LAZCLUZEIn MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.Dermatologic Adverse ReactionsRYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.RYBREVANT with LAZCLUZEIn MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.RYBREVANT as a Single AgentIn CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity.HepatotoxicityLAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).RYBREVANT with LAZCLUZEIn MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.Ocular ToxicityRYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.RYBREVANT FASPRO with LAZCLUZEIn PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.RYBREVANT with LAZCLUZEIn MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.RYBREVANT with Carboplatin and PemetrexedBased on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.RYBREVANT as a Single AgentIn CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.Embryo-Fetal ToxicityBased on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.ADVERSE REACTIONSRYBREVANT FASPRO with LAZCLUZEIn PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).RYBREVANT with LAZCLUZEIn MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).RYBREVANT with Carboplatin and PemetrexedIn MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO, RYBREVANT and LAZCLUZE.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.† RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well
solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.‡ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.§ See the NCCN Guidelines for detailed recommendations, including other treatment options.|| The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.______________________________________
1 U.S. Food & Drug Administration. Priority Review. Accessed July 2026. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
2 Harrington KJ, Rosenberg AJ, Yang MH, et al. Subcutaneous amivantamab in recurrent/metastatic head and neck squamous cell cancer after disease progression on checkpoint inhibitor and chemotherapy: Preliminary results from the phase 1b/2 OrigAMI-4 study. Oral Oncol. 2025;171:107791.
3 Kalyankrishna S, Grandis JR. Epidermal growth factor receptor biology in head and neck cancer. J Clin Oncol. 2006;24(17):2666–2672.
4 Burtness B, Rosenberg AJ, Calderon B, et al. Amivantamab in recurrent/metastatic head and neck squamous cell cancer after disease progression on immune checkpoint inhibitor and chemotherapy. Pivotal results from the phase 1b/2 OrigAMI-4 study. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31, 2026; Chicago, Illinois.
5 Burtness B, Rosenberg AJ, Calderon B, et al. Amivantamab in recurrent/metastatic head and neck squamous cell carcinoma after checkpoint inhibitor and chemotherapy: pivotal results from the phase 1b/2 OrigAMI-4 study. J Clin Onc. May 31, 2026. doi:10.1200/JCO-26-01042.
6 ClinicalTrials.gov. A study of amivantamab alone or in addition to other treatment agents in participants with recurrent/metastatic head and neck cancer (OrigAMI-4). Accessed July 2026. https://clinicaltrials.gov/study/NCT06385080?term=OrigAMI-4&limit=10&rank=1.
7 Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. Epidemiology, risk factors, and prevention of head and neck squamous cell carcinoma. Med Sci (Basel). 2023;11(2):42. Published 2023 Jun 13. doi:10.3390/medsci11020042
8 Haddad RI, Ferrarotto R, Guo Y, et al. OrigAMI-5: A randomized, phase 3 study of amivantamab plus pembrolizumab and carboplatin vs standard of care pembrolizumab plus platinum and 5-fluorouracil as first-line treatment in recurrent/metastatic head and neck cancer. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30, 2026; Chicago, Illinois.
9 Ghiani L, Chiocca S. High risk-human apillomavirus in HNSCC: Present and future challenges for pigenetic therapies. Int J Mol Sci. 2022;23(7):3483. doi.org/10.3390/ijms23073483
10 Ferris RL, Blumenschein Jr G, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and eck. New Eng J Med. 2016;375(19):1856-1867. doi:10.1056/NEJMoa1602252
11 Wise-Draper TM, Bahig H, Tonneau M, Karivedu V, Burtness B. Current therapy for metastatic head and neck ancer: Evidence, opportunities, and challenges. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_350442
12 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed July 2026.To view the most recent and complete version of the guideline, go online to NCCN.org.
13 RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
14 RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.com  Investor contact:
Jess Margevich 
investor-relations@its.jnj.com U.S. Medical Inquiries: +1 800 526-7736   View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnsons-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-receives-us-fda-priority-review-as-potential-first-in-class-egfr--and-met-targeted-subcutaneous-treatment-for-advanced-head-and-neck-cancer-302838985.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer

Johnson & Johnson Completes Acquisition of Firefly Bio, Inc. to Advance Next-Generation Oncology InnovationJuly 29, 2026 5:42 PM
Business Wire Broadens capabilities in targeting pan-KRAS and other drivers of hard-to-treat cancers Adds novel degrader antibody conjugate platform designed to address key limitations of existing therapies Advances leadership in next-generation antibody engineering to accelerate oncology innovation Johnson & Johnson (NYSE: JNJ) today announced the successful completion of its acquisition of Firefly Bio, Inc., a biotechnology company advancing its proprietary Firelink™ degrader antibody conjugate (DAC) platform, for $1 billion in cash. The Firelink™ DAC platform expands Johnson & Johnson’s oncology portfolio and advances its ambition to develop targeted therapies for some of the most prevalent and difficult-to-treat solid tumors, including KRAS-driven cancers, where patients continue to face significant unmet need1. With the close of the transaction, Johnson & Johnson further deepens its capabilities in next-generation antibody engineering and broadens its strategy for tackling complex tumor biology. The Firelink™ DAC platform is designed to deliver highly selective protein degraders directly to cancer cells, enabling targeted activity while preserving healthy tissue—a key limitation of many current treatment approaches. “The completion of this acquisition marks an important step in advancing new approaches to better address difficult-to-treat solid tumors,” said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. “By bringing together Firefly Bio’s differentiated technology with our deep expertise in oncology and antibody engineering, we are well positioned to accelerate the development of more precise and effective therapies. We are excited to welcome the talented Firefly Bio team to Johnson & Johnson as we continue this work together.” Johnson & Johnson is at the forefront of oncology therapies Anchored in decades of oncology leadership, Johnson & Johnson is redefining standards of care and expanding what is possible for people living with cancer. Integrating Firefly Bio’s capabilities further strengthens this commitment, enabling new approaches to address some of the most challenging solid tumors, including those driven by KRAS. About the agreement The transaction will be accounted for as an asset acquisition, resulting in an in-process research and development charge of approximately $1 billion in the third quarter of 2026. Johnson & Johnson expects the transaction to dilute adjusted operational earnings per share and adjusted earnings per share by approximately $0.46 in 2026 and approximately $0.08 in 2027. Please refer to the Current Report on Form 8-K furnished to the SEC on the date of this press release for updated full year 2026 guidance. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us @JNJInnovMed. Caution Concerning Forward-Looking Statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of Firefly Bio, Inc. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the acquisition may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; economic conditions, including currency exchange and interest rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and trends toward health care cost containment. In addition, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate Firefly Bio, Inc. as well as the ability to ensure successful development and regulatory approval of Firefly Bio, Inc. programs. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Non-GAAP Financial Measures This press release includes adjusted operational earnings per share and adjusted earnings per share, which represent non-GAAP financial measures. Johnson & Johnson believes that providing these non-GAAP financial measures enhance the company’s and investors’ understanding of our financial performance. Non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures determined or calculated in accordance with GAAP. The company’s definitions of its non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. The most directly comparable GAAP measure to adjusted operational earnings per share and adjusted earnings per share is earnings per share, or EPS. The Company is not providing reconciliations to EPS, however, because Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis as the company is unable to predict with reasonable certainty the ultimate outcome of adjusted items, such as legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP. 1 https://www.sciencedirect.com/science/article/pii/S1535610826000103#bib19 View source version on businesswire.com: https://www.businesswire.com/news/home/20260729714290/en/ Media contact:
J&J Global Media Relations
Media-relations@its.jnj.com Investor contact:
Jess Margevich
investor-relations@its.jnj.com Original: Johnson & Johnson Completes Acquisition of Firefly Bio, Inc. to Advance Next-Generation Oncology Innovation

Johnson & Johnson Announces Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs and Transform Autoimmune Disease Through Immune ResetJuly 29, 2026 5:28 PM
Business Wire Advances differentiated immunology program with the potential to address significant unmet need in immune-mediated disease Novel in vivo CAR-T platform is designed to generate CAR-T therapies directly within the body, enabling scalable treatments with durable, disease-modifying, and curative potential Strengthens Johnson & Johnson's leadership in immunology and CAR-T innovation Grants Johnson & Johnson an exclusive option to acquire Sail Johnson & Johnson1 (NYSE: JNJ) today announced strategic agreements and collaboration with Sail Biomedicines (Sail), a biotechnology company developing in vivo CAR-T therapies for immune-mediated diseases. Johnson & Johnson will collaborate with Sail to advance its lead immune-mediated disease program and broader platform technology, with incentives to expand the application of Sail's in vivo CAR-T platform across additional therapeutic targets over time. Johnson & Johnson2 will also make an equity investment in Sail. Additionally, Johnson & Johnson has been granted an exclusive option to acquire Sail for $2.58 billion. In vivo CAR-T therapies represent one of the most promising frontiers in medicine, with the potential to deliver transformative therapies across a range of cancer and immune-mediated diseases. Unlike traditional cell therapies, Sail’s lead program and platform are designed to reprogram a patient’s immune cells directly within the body, with the goal of resetting the immune system and delivering durable disease control. Through this collaboration, Johnson & Johnson and Sail will combine their expertise to advance innovative in vivo CAR-T therapies that have the potential to improve patient outcomes and ultimately deliver curative treatment approaches for people living with complex diseases. “People living with serious immune-mediated diseases continue to need treatments that can deliver deeper, more durable disease control,” said John Reed, Executive Vice President, Innovative Medicine Research & Development, Johnson & Johnson. “Sail’s innovative platform represents an exciting new approach that seeks to harness the power of CAR-T therapy in a simpler, more scalable way. By working together with Sail, we aim to accelerate the development of innovative therapies that have the potential to fundamentally transform how immune-mediated diseases are treated.” Building on its leadership in immunology and established expertise in CAR-T therapy within oncology, Johnson & Johnson continues to invest in emerging technologies with the potential to reshape disease treatment and transform patient outcomes. The agreement with Sail expands the Company’s capabilities in in vivo CAR-T, strengthens its position at the forefront of immune system reprogramming and immune reset, and creates opportunities to advance future programs across a range of complex diseases. Under the terms of the agreements, Johnson & Johnson would make total initial payments of $785 million3, including a $465 million equity investment, and additional contingent payments of $140 million if certain development milestones are achieved. Subject to Johnson & Johnson’s decision to exercise the option, Johnson & Johnson would make an additional payment of $2.58 billion. Assuming exercise of the option, Johnson & Johnson expects the agreements to dilute adjusted operational earnings per share and adjusted earnings per share by approximately $0.18 in 2026 and approximately $1.28 in 2027. Please refer to the Current Report on Form 8-K furnished to the SEC on the date of this press release for updated full year 2026 guidance. The transactions are subject to applicable regulatory approvals and/or other conditions. About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us @JNJInnovMed. Caution Concerning Forward-Looking Statements:
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to the investment in and collaboration with Sail Biomedicines. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: the satisfaction of closing conditions for the equity investment; the possibility that the investment will not be completed in the expected timeframe or at all; the potential that the expected benefits of the investment, if fully completed, may not be realized or may take longer to realize than expected; the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Non-GAAP Financial Measures
This press release includes adjusted operational earnings per share and adjusted earnings per share, which represent non-GAAP financial measures. Johnson & Johnson believes that providing these non-GAAP financial measure enhances the company’s and investors’ understanding of our financial performance. Non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures determined or calculated in accordance with GAAP. The company’s definitions of its non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. The most directly comparable GAAP measure to adjusted operational earnings per share and adjusted earnings per share is earnings per share, or EPS. The Company is not providing reconciliations to EPS, however, because Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis as the company is unable to predict with reasonable certainty the ultimate outcome of adjusted items, such as legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP. _______________________________  1 Collaboration agreement between Sail and Janssen Biotech, Inc., a Johnson & Johnson company. 2 Equity investment made by Johnson & Johnson Innovation – JJDC Inc., Johnson & Johnson’s corporate venture capital arm. 3 Payments to be allocated amongst Sail and Sail shareholders based on the terms of the agreements.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260729687815/en/ Media contact:
J&J Global Media Relations
Media-relations@its.jnj.com Investor contact:
Jessica Margevich
investor-relations@its.jnj.com Original: Johnson & Johnson Announces Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs and Transform Autoimmune Disease Through Immune Reset

Johnson & Johnson Announces a Proposed Resolution of Ovarian Talc LitigationJuly 27, 2026 6:31 PM
Business Wire Follows Favorable Multi-District Litigation Court Causation Ruling and the Company’s Successful Strategy to Defend Each Case Efficient Conclusion to the Talc Litigation that Eliminates Expense Associated with Litigating Remaining Roughly 76,000 Ovarian Talc Claims Johnson & Johnson (NYSE: JNJ) (the "Company") today announced that it has reached an agreement for a comprehensive resolution of the remaining talc litigation with the plaintiff firms leading the federal Multi-District Litigation (MDL) and related state court proceedings, conditioned on, among other things, the express participation of at least 95% of the remaining claims. The proposed resolution follows a favorable ruling by the MDL court, and acknowledgment by plaintiffs’ counsel, regarding plaintiffs’ inability to prove that the Company’s talc products caused any particular claimant’s ovarian cancer (“specific causation”). “After decades of litigation and full vetting of the science in an extensive hearing, plaintiffs effectively conceded their inability to prove specific causation by withdrawing their experts on the topic in two bellwether cases. In a watershed moment, the Court thereafter ordered plaintiffs to show why the remaining claims should not be dismissed, confirming what we have maintained for years: that these claims lack scientific merit and were sustained only by unreliable expert opinions that could not survive rigorous judicial review," said Erik Haas, Worldwide Vice President of Litigation, Johnson & Johnson. "The Court’s order placed plaintiffs in an untenable position of having to present specific causation evidence to maintain their claims that does not exist. While we are confident the Company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives." The MDL Court’s recent specific causation ruling confirmed the Company's longstanding position that these claims lack scientific merit. The Company has prevailed in the overwhelming majority of ovarian cases tried to date. On July 22, 2026, the MDL court ordered plaintiffs to show why the remaining pending talc claims should not be dismissed for inability to prove specific causation. The order followed plaintiffs’ withdrawal of their specific causation experts in two bellwether cases, after a hearing that demonstrated their opinions were not based upon reliable scientific methodologies. The developments affirmed the Company’s longstanding position that the talc claims are premised on junk science that has been rejected for decades by United States scientific organizations and regulatory agencies, as well as independent experts. The proposed resolution constitutes an efficient conclusion to the talc litigation. The resolution: Requires and is conditioned on—among other criteria—the participation of lead plaintiff firms in all ovarian talc litigation pending in state and federal court, representing at least 95% of the remaining claims. Calls for per claim payments, with a $5.5 billion commitment by the Company and the first payment of no more than $3 billion to be made in 2027 and no additional payments due before 2028. Complements the progress the Company already has made to resolve the talc litigation, including previously settling about 95% of filed mesothelioma lawsuits, all State consumer protection claims, and all talc-supplier disputes. Brings finality to this meritless 15-year litigation. Studies show talc is safe, does not contain asbestos and does not cause cancer. Research, clinical evidence, and decades of studies by independent medical experts around the world continue to support the safety of cosmetic talc. Prior to its separation, Johnson & Johnson agreed to retain all the talc-related liabilities and indemnify Kenvue for any and all costs—arising from litigation in the United States and Canada. As part of a worldwide portfolio assessment, Johnson & Johnson made the commercial decision to discontinue talc-based JOHNSON’S® Baby Powder globally in 2023. Additionally, Johnson & Johnson separated its consumer health business, Kenvue, in August 2023. Additional information on the Company's position and the science supporting the safety of talc is available at www.FactsAboutTalc.com. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at www.jnj.com. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the proposed resolution of ovarian talc litigation. The reader is cautioned not to rely on these forward-looking statements. The information contained in this press release is for informational purposes only and should not be construed as a commitment by the Company to engage in any specific strategy or course of action. Due to the inherent uncertainty of litigation, the Company cannot predict the timing, ultimate outcome or financial impact of this matter, or any other ongoing or future litigation. The forward-looking statements in this press release are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: significant adverse litigation or government action, including related to product liability claims; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory actions; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. The Company expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260727623671/en/ Media contact: 
media-relations@its.jnj.com Investor contact: 
investor-relations@its.jnj.com  Original: Johnson & Johnson Announces a Proposed Resolution of Ovarian Talc Litigation

TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myelomaJuly 23, 2026 8:30 AM
PR Newswire (US) Investigational MonumenTAL-6 trial is the first and only Phase 3 study of a dual antigen, BCMA and GPRC5D targeting regimen in relapsed/refractory multiple myelomaFifth positive Phase 3 study evaluating Johnson & Johnson's multiple myeloma T-cell therapy portfolio in second line, further strengthening the company's leadership and commitment to advancing immunotherapy-based regimens earlier in the treatment journeyRARITAN, N.J., July 23, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ), a worldwide leader in multiple myeloma therapies, today announced positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating TECVAYLI® (teclistamab-cqyv) + TALVEY® (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and TALVEY® + pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received 1 to 4 prior lines of therapy, including an anti-CD38 antibody and lenalidomide.1 The study demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for both investigational arms compared with investigator's choice standard of care. TECVAYLI® + TALVEY® delivered the greatest benefit, reducing the risk of disease progression or death by 89% (HR, 0.11) and the risk of death by 62% (HR, 0.38).1 This represents the lowest hazard ratio seen across any Phase 3 study evaluating bispecific therapies in relapsed/refractory multiple myeloma.1 Expert and company perspectives reinforce the potential of TECVAYLI® + TALVEY®"These findings add to a growing body of Phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey," said Ajay K. Nooka, M.D., M.P.H., F.A.C.P., Director, Myeloma Program, Department of Hematology and Medical Oncology, Emory University School of Medicine.* "TECVAYLI and TALVEY together generated deep and durable responses, demonstrating what's possible by targeting BCMA and GPRC5D at the same time, and further reinforcing the potential of this off-the-shelf regimen to improve outcomes for patients across practice settings." "At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care and strengthen the growing body of evidence supporting our leadership in this space. By continuing to expand treatment options across the disease continuum, we are moving closer to our ambition of one day curing this disease." Topline results from the Phase 3 MonumenTAL-6 study The MonumenTAL-6 study evaluated TECVAYLI® in combination with TALVEY® (Tec-Tal) or TALVEY® with pomalidomide (Tal-P) compared to the investigator's choice of either elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in participants with RRMM who have received at least one line of therapy, including an anti-CD38 antibody and lenalidomide.1 Both the Tec-Tal and Tal-P regimens met the study's primary endpoint of PFS, demonstrating statistically significant and clinically meaningful improvements versus standard of care.1 Risk of progression or death was reduced in the Tec-Tal arm by 89% (hazard ratio [HR], 0.11; 95% confidence interval [CI], 0.08-0.16; p

Johnson & Johnson Announces Collaboration with TIME to Introduce New Healthcare Champion of the Year AwardJuly 16, 2026 8:11 AM
Business Wire New branded recognition will spotlight the care, innovation and grit of U.S. healthcare professionals making a meaningful difference for patients, colleagues and communities. The collaboration will recognize healthcare leaders helping strengthen care amid growing pressure on health systems. Nominations will open on July 16, 2026 and close at 5:00 p.m. ET on August 28, 2026. Johnson & Johnson (NYSE: JNJ) today announced with TIME the launch of the Healthcare Champion of the Year. The new branded recognition will honor healthcare professionals in the U.S., selected by Johnson & Johnson and a panel of industry experts, whose care, innovation and grit are driving health system change to advance better care for all. Nominations for the inaugural TIME Healthcare Champion of the Year, in partnership with Johnson & Johnson, a branded award, will open July 16, 2026 at www.jnj.com/healthcare-champion-of-the-year and close by 5:00 p.m. ET on August 28, 2026. The honoree will be announced leading up to TIME’s “A Year in TIME” celebration, which will take place on December 9, 2026 in New York City. Recognizing the People Shaping Health Itself The new Healthcare Champion of the Year award will honor individuals who are shaping the future of health. Across the country, healthcare professionals are navigating a series of the most consequential moments in healthcare. When healthcare systems are under strain, leadership at the point of care matters. It can change how a patient experiences a diagnosis, how a team pushes through pressure and how a community gets connected to care. Through this partnership, Johnson & Johnson and TIME will shine a light on healthcare leaders whose care, innovation and grit are helping make better care possible. “At Johnson & Johnson, Our Credo begins with our responsibility to patients, doctors, nurses and all others who use our medicines and medical technology. That responsibility guides how we show up for the people at the heart of care,” said Vanessa Broadhurst, Executive Vice President, Global Corporate Affairs, Johnson & Johnson. “Healthcare professionals bring skill, compassion and resolve to some of the most important moments in people’s lives. With the Healthcare Champion of the Year Award, we proudly recognize those whose compassion, innovation, and grit are transforming patient care today and building a healthier tomorrow.” Why this Recognition Matters Healthcare is advancing rapidly, yet gaps in access to quality care persist. The Healthcare Champion of the Year award is designed to spotlight impact, recognizing what becomes possible when healthcare professionals are supported and empowered to lead change where it matters most. The recognition builds on Johnson & Johnson’s long-standing commitment to improving health outcomes by championing nursing and a thriving health workforce. Through J&J CareCommunity, the company’s global social impact platform, J&J helps equip nurses and community health workers with the skills, resources, and connections they need to strengthen health systems, expand access to care, and improve health outcomes in communities around the world. Together, these efforts reflect a simple belief: the future of healthcare depends on recognizing, elevating and supporting the people who strengthen patient care every day. How to Submit a Nomination Eligible nominees may include physicians, nurses, advanced practice clinicians, surgeons, community health workers, care navigators and other healthcare professionals actively involved in clinical care or care delivery in the United States. Nominees may be at any stage of their career and should demonstrate real-world impact by how they show up for patients, colleagues and communities. Nominations should reflect at least one of the program’s core themes: grit, innovation or patient care. Nominations will open July 16, 2026 and close by 5:00 p.m. ET on August 28, 2026. The winner will be selected by Johnson & Johnson and a panel of Johnson & Johnson-selected industry experts. To learn more or submit a nomination, visit https://www.jnj.com/healthcare-champion-of-the-year. Terms and conditions apply: https://www.jnj.com/healthcare-champion-of-the-year/terms-and-conditions. Johnson & Johnson’s Commitment to the Global Health Workforce As healthcare advances, we believe in supporting those who shape it – healthcare professionals. J&J CareCommunity is a global social impact platform from Johnson & Johnson to advance access to quality care through championing nurses and community health workers. We do this by collaborating with those closest to the challenge to connect more people to care. Learn more at www.jnj.com/jnjcarecommunity. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. View source version on businesswire.com: https://www.businesswire.com/news/home/20260716841756/en/ Media contact:
Trish Garrity

I see JNJ looking at grabbing ATAI... this is going to be a wild ride. Spravato paved the road for BPL-003... big gains coming.

The Race to Commercialize the World’s Most Powerful Psychedelic

https://www.wsj.com/video/the-race-to-commercialize-the-worlds-most-powerful-psychedelic/F24E9B22-38D3-4BFC-B80A-3B5F73423E0C

Johnson & Johnson reports Q2 2026 results, raises 2026 outlookJuly 15, 2026 6:20 AM
Business Wire 2026 Second-Quarter reported sales growth of 6.6% to $25.3 Billion with operational growth of 5.6%* and adjusted operational growth of 5.7%* 2026 Second-Quarter earnings per share (EPS) of $2.27 and adjusted EPS* of $2.90 Strong operational performance results in the Company increasing 2026 guidance with estimated reported sales of $101.1 Billion or 7.3% at the midpoint, and increasing adjusted EPS* guidance by $0.13 to $11.68 or 8.2% at the midpoint. The adjusted operational EPS* is increasing by $0.18 to $11.58 or 7.3% at the midpoint Advancing significant innovation for patients with approvals of TREMFYA to inhibit the progression of structural joint damage in adults with active psoriatic arthritis, CAPLYTA for the prevention of relapse in schizophrenia, and Dual Energy THERMOCOOL SMARTTOUCH SF platform; fortifying future with data from RYBREVANT FASPRO in advanced head and neck cancer, TALVEY plus DARZALEX FASPRO in earlier-line relapsed or refractory multiple myeloma, and OTTAVA in upper abdominal procedures Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2026. “Johnson & Johnson delivered strong second-quarter results, demonstrating the power of our innovation, the depth of our portfolio and the momentum in our pipeline as we advance transformative treatments that address the world’s toughest health challenges,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “With raised guidance and quarterly sales surpassing $25 billion, we are on track to meet our 2026 target of more than $100 billion in annual revenue for the first time in our Company’s 140-year history.” Overall financial results   Q2 ($ in Millions, except EPS)   2026   2025   % Change Reported Sales   $25,310   $23,743   6.6% Net Earnings   $5,534   $5,537   -0.1% EPS (diluted)   $2.27   $2.29   -0.9%                 Q2 Non-GAAP* ($ in Millions, except EPS)   2026   2025   % Change Operational Sales1,2           5.6% Adjusted Operational Sales1,3           5.7% Adjusted Net Earnings1,4   $7,081   $6,699   5.7% Adjusted EPS (diluted)1,4   $2.90   $2.77   4.7% Free Cash Flow5,6   ~$8,700   $6,214     1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Non-GAAP financial measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 6 Second-quarter YTD 2026 is estimated as of July 15, 2026 Note: values may have been rounded Regional sales results Q2       % Change   ($ in Millions)   2026   2025   Reported   Operational1,2   Currency   Adjusted Operational1,3 U.S.   $14,533   $13,544   7.3%   7.3   -   7.4 International   10,777   10,199   5.7   3.4   2.3   3.5 Worldwide   $25,310   $23,743   6.6%   5.6   1.0   5.7   1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Segment sales results Q2       % Change   ($ in Millions)   2026   2025   Reported   Operational1,2   Currency   Adjusted Operational1,3 Innovative Medicine   $16,384   $15,202   7.8%   6.8   1.0   6.9 MedTech   8,926   8,541   4.5   3.6   0.9   3.7 Worldwide   $25,310   $23,743   6.6%   5.6   1.0   5.7   1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Note: values may have been rounded Second-Quarter 2026 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 6.8%*, with divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by DARZALEX, CARVYKTI, TECVAYLI and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and Other Immunology in Immunology, and SPRAVATO and CAPLYTA in Neuroscience. Growth was partially offset by STELARA (an approximate 760 basis points impact) and REMICADE in Immunology, as well as IMBRUVICA and ZYTIGA in Oncology. MedTech MedTech worldwide operational sales grew 3.6%*, with net acquisitions and divestitures negatively impacting growth by 10 basis points. Growth was primarily driven by wound closure products and biosurgery products in Surgery, electrophysiology products and Shockwave in Cardiovascular, contact lenses in Vision, and trauma in Orthopaedics. Full-year 2026 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) July 2026 April 2026 Adjusted Operational Sales1,2 Change vs. Prior Year / Mid-point 6.2% – 6.8% / 6.5% 5.6% – 6.6% / 6.1% Operational Sales2 / Mid-point Change vs. Prior Year / Mid-point $100.3B – $100.9B / $100.6B 6.5% – 7.1% / 6.8% $99.7B – $100.7B / $100.2B 5.9% – 6.9% / 6.4% Estimated Reported Sales3/ Mid-point Change vs. Prior Year / Mid-point $100.8B – $101.4B / $101.1B 7.0% – 7.6% / 7.3% $100.3B – $101.3B / $100.8B 6.5% – 7.5% / 7.0% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $11.50 – $11.65 / $11.58 6.6% – 8.0% / 7.3% $11.30 – $11.50 / $11.40 4.7% – 6.7% / 5.7% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $11.60 – $11.75 / $11.68 7.5% – 8.9% / 8.2% $11.45 – $11.65 / $11.55 6.1% – 8.1% / 7.1%   1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: July 2026 = $1.15 and April 2026 = $1.17 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items Note: percentages may have been rounded Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com. Regulatory Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform1 Press Release   CHMP recommendation advances Johnson & Johnson’s TECVAYLI (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma Press Release   FDA approves label expansion, cementing TREMFYA as the only IL-23 inhibitor proven to help stop further joint damage Press Release   FDA approves CAPLYTA (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia Press Release   Johnson & Johnson Announces CE Mark Approval for the New ETHICON 4000 Stapler Press Release   FDA grants Priority Review for IMAAVY (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA) Press Release Data Releases Johnson & Johnson presents new IMAAVY (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravis Press Release   New TALVEY (talquetamab-tgvs) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma Press Release   IMAAVY (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies Press Release   Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study Press Release   Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's disease Press Release   RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited Press Release   Johnson & Johnson's Phase 3 prostate cancer study shows ERLEADA (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm Press Release   RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancer Press Release   New TECVAYLI (teclistamab-cqyv) data demonstrate superior progression-free and overall survival as early as first relapse in multiple myeloma Press Release   Johnson & Johnson study shows TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn's disease Press Release   Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease Press Release   Johnson & Johnson Announces Pivotal Clinical Study Results for a New Soft-Tissue Surgical Robotic System Press Release   CAPLYTA (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis Press Release   IMAAVY (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG) Press Release Product Launch Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave C2 Aero Coronary IVL Catheter Press Release Other DePuy Synthes Appoints Christina Zamarro as Chief Financial Officer1 Press Release   Johnson & Johnson Invests more than $1 Billion to Strengthen U.S. Vision Manufacturing in Jacksonville, Florida Press Release   Johnson & Johnson Expands U.S. Availability of TECNIS PureSee IOL, an Advanced Lens Option for Cataract Surgeons and Patients Press Release   Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform Press Release   DePuy Synthes Announces Agreement to Acquire Miniature Radiofrequency Tracking Technology Across its Joint Reconstruction Portfolio Press Release   DePuy Synthes Enters Exclusive U.S., Canada and Australia Distribution Agreement for CGBIO’s NOVOSIS Press Release   Groundbreaking global survey captures the significant patient burden experienced with current standard-of-care bladder cancer treatments, underscoring urgency for continued innovation Press Release   Johnson & Johnson Appoints Ryan Koors as Vice President, Investor Relations Press Release   Johnson & Johnson Launches Landmark Head-to-Head Pulsed Field Ablation Trial in Persistent Atrial Fibrillation Press Release   Johnson & Johnson Showcases CARTO-Powered Innovation, Including Debut of CARTOSOUND SONATA, to Advance Arrhythmia Care at HRS 2026 Press Release   1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; and the Company's ability to successfully separate the Company's Orthopaedics business and realize the anticipated benefits from the planned separation. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Johnson & Johnson and Subsidiaries Supplementary Sales Data   (Unaudited; Dollars in Millions) SECOND QUARTER SIX MONTHS Percent Change Percent Change   2026   2025   Total   Operations   Currency   2026   2025   Total   Operations   Currency Sales to customers by segment of business   Innovative Medicine U.S. $ 9,979 9,161 8.9 % 8.9 - $ 18,850 17,253 9.3 % 9.3 - International   6,405 6,041 6.0 3.6 2.4   12,960 11,822 9.6 3.9 5.7   16,384 15,202 7.8 6.8 1.0   31,810 29,075 9.4 7.1 2.3   MedTech U.S.   4,554 4,383 3.9 3.9 -   9,013 8,596 4.8 4.8 - International   4,372 4,158 5.2 3.2 2.0   8,549 7,965 7.3 3.2 4.1   8,926 8,541 4.5 3.6 0.9   17,562 16,561 6.0 4.1 1.9   U.S.   14,533 13,544 7.3 7.3 -   27,863 25,849 7.8 7.8 - International   10,777 10,199 5.7 3.4 2.3   21,509 19,787 8.7 3.6 5.1 Worldwide $ 25,310 23,743 6.6 % 5.6 1.0 $ 49,372 45,636 8.2 % 6.0 2.2   Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Supplementary Sales Data   (Unaudited; Dollars in Millions) SECOND QUARTER SIX MONTHS Percent Change Percent Change   2026   2025   Total   Operational   Currency   2026   2025   Total   Operational   Currency Sales to customers by geographic area   U.S. $ 14,533 13,544 7.3 % 7.3 - $ 27,863 25,849 7.8 % 7.8 -   Europe   5,726 5,387 6.3 3.3 3.0   11,574 10,497 10.3 3.0 7.3 Western Hemisphere excluding U.S.   1,309 1,206 8.5 2.7 5.8   2,602 2,373 9.6 2.6 7.0 Asia-Pacific, Africa   3,742 3,606 3.8 3.9 (0.1)   7,333 6,917 6.0 4.9 1.1 International   10,777 10,199 5.7 3.4 2.3   21,509 19,787 8.7 3.6 5.1   Worldwide $ 25,310 23,743 6.6 % 5.6 1.0 $ 49,372 45,636 8.2 % 6.0 2.2   Note: Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings   (Unaudited; in Millions Except Per Share Figures) SECOND QUARTER   2026 2025 Percent
Increase
(Decrease) Amount Percent
to Sales Amount Percent
to Sales Sales to customers $ 25,310 100.0 $ 23,743 100.0 6.6   Cost of products sold   8,051 31.8   7,628 32.1 5.5   Gross Profit   17,259 68.2   16,115 67.9 7.1   Selling, marketing and administrative expenses   6,432 25.4   5,889 24.8 9.2   Research and development expense   3,653 14.4   3,516 14.8 3.9   Interest (income) expense, net   62 0.2   48 0.2 Other (income) expense, net   331 1.3   107 0.5 Restructuring   34 0.2   64 0.3 Earnings before provision for taxes on income   6,747 26.7   6,491 27.3 3.9   Provision for taxes on income   1,213 4.8   954 4.0 27.1   Net earnings $ 5,534 21.9 $ 5,537 23.3 (0.1 )   Net earnings per share (Diluted) $ 2.27 $ 2.29 (0.9 )   Average shares outstanding (Diluted)   2,440.1   2,419.1   Effective tax rate   18.0 %   14.7 %   Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 8,660 34.2 $ 8,188 34.5 5.8   Net earnings $ 7,081 28.0 $ 6,699 28.2 5.7   Net earnings per share (Diluted) $ 2.90 $ 2.77 4.7   Effective tax rate   18.2 %   18.2 %   (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Condensed Consolidated Statement of Earnings   (Unaudited; in Millions Except Per Share Figures) SIX MONTHS   2026 2025     Percent
Increase
(Decrease) Amount Percent
to Sales Amount Percent
to Sales Sales to customers $ 49,372 100.0 $ 45,636   100.0   8.2   Cost of products sold   16,157 32.7   14,985   32.8   7.8   Gross Profit   33,215 67.3   30,651   67.2   8.4   Selling, marketing and administrative expenses   12,466 25.3   11,001   24.1   13.3   Research and development expense   7,180 14.5   6,741   14.8   6.5   In-process research and development impairments   36 0.1   -   -   Interest (income) expense, net   105 0.2   (80 ) (0.2 ) Other (income) expense, net   625 1.3   (7,214 ) (15.8 ) Restructuring   66 0.1   81   0.2   Earnings before provision for taxes on income   12,737 25.8   20,122   44.1   (36.7 ) Provision for taxes on income   1,968 4.0   3,586   7.9   (45.1 ) Net earnings $ 10,769 21.8 $ 16,536   36.2   (34.9 )   Net earnings per share (Diluted) $ 4.41 $ 6.82   (35.3 )   Average shares outstanding (Diluted)   2,443.9   2,423.3     Effective tax rate   15.5 %   17.8   %   Adjusted earnings before provision for taxes and net earnings (1) Earnings before provision for taxes on income $ 16,481 33.4 $ 16,199   35.5   1.7   Net earnings $ 13,695 27.7 $ 13,405   29.4   2.2   Net earnings per share (Diluted) $ 5.60 $ 5.53   1.3   Effective tax rate   16.9 %   17.2   %   (1) See Reconciliation of Non-GAAP Financial Measures. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measures   Second Quarter Six Months Ended   (Dollars in Millions Except Per Share Data)   2026   2025   2026   2025 Net Earnings, after tax- as reported $5,534   $5,537   $10,769   $16,536     Pre-tax Adjustments Litigation related 267   57   597   (6,909 ) Intangible Asset Amortization expense 1,245   1,267   2,492   2,387   Restructuring related 1 276   79   338   134   Orthopaedics separation related 258   -   377   -   Acquisition, integration and divestiture related 80   246   176   378   (Gains)/losses on securities (213 ) 21   (272 ) 60   IPR&D impairments -   -   36   -   Other -   27   -   27     Tax Adjustments Tax impact on special item adjustments 2 (368 ) (321 ) (792 ) 994   Tax legislation and other tax related 2   (214 ) (26 ) (202 ) Adjusted Net Earnings, after tax $7,081   $6,699   $13,695   $13,405   Average shares outstanding (Diluted) 2,440.1   2,419.1   2,443.9   2,423.3   Adjusted net earnings per share (Diluted) $2.90   $2.77   $5.60   $5.53   Operational adjusted net earnings per share (Diluted) $2.86   $5.43     Notes: 1 In the fiscal second quarter of 2026, the Company commenced a supply chain restructuring program primarily in the Innovative Medicine segment to exit certain manufacturing locations as part of its optimization efforts to streamline operations. The program is expected to be substantially completed by the end of fiscal year 2029 with estimated costs between $650 - $750 million, and include site and supplier exit costs, decommissioning and asset impairment costs. Restructuring expenses of $200 million, primarily related to asset impairments, were recorded in the fiscal second quarter of 2026.   In fiscal 2025, the Company initiated a restructuring program of its Surgery franchise within the MedTech segment to simplify and focus operations by exiting certain non-strategic product lines and optimize select sites across the network. Restructuring expenses of $59 million were recorded in the fiscal second quarter of 2026 ($114 million Q2 2026 YTD) and $29 million in the fiscal second quarter of 2025 ($29 million Q2 2025 YTD) and primarily include costs related to product exits. This program is expected to be substantially completed by the end of fiscal year 2026.   In fiscal 2023, the Company initiated a restructuring program of its Orthopaedics franchise within the MedTech segment to streamline operations by exiting certain markets, product lines and distribution network arrangements. The restructuring expenses of $17 million in the fiscal second quarter of 2026 ($24 million Q2 2026 YTD) and $50 million in the fiscal second quarter of 2025 ($105 million Q2 2025 YTD) includes costs related to market and product exits. This program will be completed as of Q4 2026 at a total cost of approximately $1 billion.   2 The tax impact related to special item adjustments reflects the current and deferred income taxes associated with the above pre-tax special items in arriving at adjusted earnings. Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measure       Adjusted Operational Sales Growth SECOND QUARTER 2026 ACTUAL vs. 2025 ACTUAL   Segments       Innovative Medicine MedTech Total       WW As Reported 7.8% 4.5% 6.6% U.S. 8.9% 3.9% 7.3% International 6.0% 5.2% 5.7%       WW Currency 1.0 0.9 1.0 U.S. - - - International 2.4 2.0 2.3       WW Operational 6.8% 3.6% 5.6% U.S. 8.9% 3.9% 7.3% International 3.6% 3.2% 3.4%       All Other Acquisitions and Divestitures (A&D) 0.1 0.1 0.1 U.S. 0.0 0.2 0.1 International 0.2 0.0 0.1       WW Adjusted Operational Ex A&D 6.9% 3.7% 5.7% U.S. 8.9% 4.1% 7.4% International 3.8% 3.2% 3.5%             Note: Percentages are based on actual, non-rounded figures and may not sum Johnson & Johnson and Subsidiaries Reconciliation of Non-GAAP Financial Measure       Adjusted Operational Sales Growth SIX MONTHS 2026 ACTUAL vs. 2025 ACTUAL   Segments       Innovative Medicine MedTech Total       WW As Reported 9.4% 6.0% 8.2% U.S. 9.3% 4.8% 7.8% International 9.6% 7.3% 8.7%       WW Currency 2.3 1.9 2.2 U.S. - - - International 5.7 4.1 5.1       WW Operational 7.1% 4.1% 6.0% U.S. 9.3% 4.8% 7.8% International 3.9% 3.2% 3.6%       Caplyta (0.9)   (0.6) U.S. (1.6)   (1.0) International 0.0   0.0       All Other Acquisitions and Divestitures (A&D) 0.0 0.1 0.1 U.S. 0.0 0.2 0.1 International 0.2 0.0 0.1       WW Adjusted Operational Ex A&D 6.2% 4.2% 5.5% U.S. 7.7% 5.0% 6.9% International 4.1% 3.2% 3.7%       Note: Percentages are based on actual, non-rounded figures and may not sum   REPORTED SALES vs. PRIOR PERIOD ($MM)   REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change INNOVATIVE MEDICINE SEGMENT (2)   2026   2025   Reported   Operational (1)   Currency       2026   2025   Reported   Operational (1)   Currency                   ONCOLOGY                 US $ 4,069 3,385 20.3% 20.3% -   $ 7,684 6,398 20.1% 20.1% -   Intl   3,337 2,928 14.0% 11.2% 2.8%     6,695 5,592 19.7% 13.2% 6.5%   WW   7,406 6,312 17.3% 16.1% 1.2%     14,379 11,990 19.9% 16.9% 3.0%   DARZALEX                 US   2,435 2,017 20.7% 20.7% -     4,643 3,846 20.7% 20.7% -   Intl   1,772 1,521 16.4% 13.5% 2.9%     3,528 2,930 20.4% 13.7% 6.7%   WW   4,207 3,539 18.9% 17.6% 1.3%     8,171 6,776 20.6% 17.7% 2.9%   CARVYKTI                 US   472 358 31.7% 31.7% -     905 676 33.8% 33.8% -   Intl   185 81 * * *     349 132 * * *   WW   657 439 49.4% 47.7% 1.7%     1,254 808 55.1% 52.1% 3.0%   TECVAYLI                 US   186 114 63.9% 63.9% -     313 219 43.1% 43.1% -   Intl   74 52 40.7% 39.2% 1.5%     148 98 51.1% 45.2% 5.9%   WW   260 166 56.5% 56.1% 0.4%     462 317 45.5% 43.7% 1.8%   TALVEY                 US   112 82 36.2% 36.2% -     213 150 41.7% 41.7% -   Intl   62 24 * * *     113 42 * * *   WW   174 106 63.3% 62.6% 0.7%     326 192 69.3% 67.2% 2.1%   RYBREVANT / LAZCLUZE                 US   190 139 36.8% 36.8% -     365 252 45.0% 45.0% -   Intl   99 41 * * *     181 69 * * *   WW   289 179 60.8% 61.6% (0.8)%     546 320 70.4% 69.9% 0.5%   ERLEADA                 US   396 378 4.7% 4.7% -     738 670 10.2% 10.2% -   Intl   599 530 12.9% 9.7% 3.2%     1,206 1,009 19.4% 12.5% 6.9%   WW   995 908 9.5% 7.6% 1.9%     1,944 1,679 15.8% 11.6% 4.2%   IMBRUVICA                 US   149 239 (37.6)% (37.6)% -     292 474 (38.4)% (38.4)% -   Intl   449 496 (9.5)% (11.8)% 2.3%     966 970 (0.4)% (6.7)% 6.3%   WW   599 735 (18.6)% (20.2)% 1.6%     1,259 1,444 (12.9)% (17.1)% 4.2%   OTHER ONCOLOGY (3)                 US   131 56 * * -     216 110 94.5% 94.5% -   Intl   97 181 (46.5)% (45.7)% (0.8)%     203 341 (40.5)% (41.3)% 0.8%   WW   226 238 (4.6)% (3.9)% (0.7)%     418 452 (7.4)% (8.0)% 0.6%                                   See footnotes at end of schedule                                     REPORTED SALES vs. PRIOR PERIOD ($MM)   REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change     2026   2025   Reported   Operational (1)   Currency       2026   2025   Reported   Operational (1)   Currency   IMMUNOLOGY                 US $ 2,372 2,505 (5.3)% (5.3)% -   $ 4,227 4,701 (10.1)% (10.1)% -   Intl   1,473 1,489 (1.0)% (3.5)% 2.5%     2,997 2,999 (0.1)% (5.0)% 4.9%   WW   3,844 3,993 (3.7)% (4.6)% 0.9%     7,224 7,700 (6.2)% (8.1)% 1.9%   TREMFYA                 US   1,465 796 84.2% 84.2% -     2,507 1,395 79.7% 79.7% -   Intl   581 391 48.7% 44.2% 4.5%     1,147 747 53.6% 45.5% 8.1%   WW   2,046 1,186 72.5% 71.0% 1.5%     3,654 2,142 70.6% 67.8% 2.8%   SIMPONI / SIMPONI ARIA                 US   260 305 (14.6)% (14.6)% -     529 597 (11.2)% (11.2)% -   Intl   358 387 (7.3)% (9.5)% 2.2%     736 753 (2.3)% (6.9)% 4.6%   WW   618 690 (10.5)% (11.7)% 1.2%     1,265 1,349 (6.2)% (8.8)% 2.6%   REMICADE                 US   215 283 (24.1)% (24.1)% -     484 597 (19.0)% (19.0)% -   US Exports (4)   10 34 (71.0)% (71.0)% -     28 44 (37.1)% (37.1)% -   Intl   112 138 (18.4)% (20.5)% 2.1%     248 281 (11.5)% (15.4)% 3.9%   WW   338 455 (25.8)% (26.4)% 0.6%     760 922 (17.6)% (18.7)% 1.1%   STELARA                 US   336 1,078 (68.8)% (68.8)% -     556 2,059 (73.0)% (73.0)% -   Intl   404 575 (29.7)% (31.1)% 1.4%     839 1,219 (31.1)% (34.6)% 3.5%   WW   740 1,653 (55.2)% (55.7)% 0.5%     1,396 3,278 (57.4)% (58.7)% 1.3%   OTHER IMMUNOLOGY                 US   85 8 * * -     123 9 * * -   Intl   18 0 * * *     27 0 * * *   WW   104 8 * * *     150 9 * * *   NEUROSCIENCE                 US   1,659 1,377 20.5% 20.5% -     3,153 2,345 34.5% 34.5% -   Intl   678 674 0.6% (1.1)% 1.7%     1,359 1,353 0.4% (3.7)% 4.1%   WW   2,337 2,051 14.0% 13.4% 0.6%     4,512 3,698 22.0% 20.5% 1.5%   SPRAVATO                 US   514 366 40.7% 40.7% -     920 642 43.4% 43.4% -   Intl   70 50 41.2% 34.7% 6.5%     131 93 41.8% 31.9% 9.9%   WW   584 414 40.8% 40.0% 0.8%     1,052 734 43.2% 42.0% 1.2%   CAPLYTA (5)                 US   361 211 70.9% 70.9% -     631 211 * * -   Intl   - - - - -     - - - - -   WW   361 211 70.9% 70.9% -     631 211 * * -   INVEGA SUSTENNA / XEPLION /
INVEGA TRINZA / TREVICTA                 US   738 732 0.8% 0.8% -     1,496 1,357 10.2% 10.2% -   Intl   278 260 6.6% 5.1% 1.5%     558 537 3.7% (0.1)% 3.8%   WW   1,015 992 2.3% 1.9% 0.4%     2,053 1,895 8.4% 7.3% 1.1%   CONCERTA / Methylphenidate                 US   12 24 (48.6)% (48.6)% -     34 62 (45.5)% (45.5)% -   Intl   133 139 (4.2)% (4.8)% 0.6%     248 249 (0.4)% (3.0)% 2.6%   WW   146 164 (10.8)% (11.3)% 0.5%     282 312 (9.5)% (11.5)% 2.0%   OTHER NEUROSCIENCE                 US   34 45 (22.9)% (22.9)% -     72 73 (1.1)% (1.1)% -   Intl   198 226 (12.3)% (13.7)% 1.4%     422 474 (10.9)% (15.1)% 4.2%   WW   232 270 (14.0)% (15.2)% 1.2%     494 547 (9.6)% (13.2)% 3.6%                                   See footnotes at end of schedule                     REPORTED SALES vs. PRIOR PERIOD ($MM)   REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change     2026   2025   Reported   Operational (1)   Currency       2026   2025   Reported   Operational (1)   Currency   PULMONARY HYPERTENSION (PH)                 US $ 814 799 1.8% 1.8% -   $ 1,645 1,543 6.5% 6.5% -   Intl   329 314 4.9% 3.4% 1.5%     633 595 6.4% 2.3% 4.1%   WW   1,143 1,113 2.6% 2.2% 0.4%     2,278 2,138 6.5% 5.4% 1.1%   UPTRAVI                 US   386 382 1.0% 1.0% -     771 747 3.2% 3.2% -   Intl   108 94 15.0% 10.1% 4.9%     206 180 14.7% 7.7% 7.0%   WW   494 476 3.8% 2.8% 1.0%     977 927 5.4% 4.0% 1.4%   OPSUMIT / OPSYNVI                 US   416 403 3.2% 3.2% -     849 766 10.9% 10.9% -   Intl   187 180 3.9% 3.6% 0.3%     359 339 6.1% 2.7% 3.4%   WW   602 582 3.4% 3.3% 0.1%     1,208 1,104 9.4% 8.4% 1.0%   OTHER PULMONARY HYPERTENSION                 US   13 16 (16.9)% (16.9)% -     25 31 (19.0)% (19.0)% -   Intl   34 40 (14.3)% (12.7)% (1.6)%     68 77 (11.5)% (12.3)% 0.8%   WW   47 55 (15.0)% (13.9)% (1.1)%     93 107 (13.6)% (14.2)% 0.6%   INFECTIOUS DISEASES (ID)                 US   300 320 (6.3)% (6.3)% -     642 635 1.1% 1.1% -   Intl   463 484 (4.1)% (6.2)% 2.1%     1,010 971 4.1% (2.5)% 6.6%   WW   763 803 (5.0)% (6.3)% 1.3%     1,652 1,605 2.9% (1.1)% 4.0%   EDURANT / rilpivirine                 US   3 6 (49.6)% (49.6)% -     10 14 (29.3)% (29.3)% -   Intl   347 354 (1.9)% (3.8)% 1.9%     749 704 6.4% (0.3)% 6.7%   WW   350 360 (2.7)% (4.6)% 1.9%     759 718 5.7% (0.9)% 6.6%   PREZISTA / PREZCOBIX / REZOLSTA / SYMTUZA                 US   296 312 (5.1)% (5.1)% -     630 617 2.1% 2.1% -   Intl   76 85 (10.4)% (12.8)% 2.4%     185 183 1.2% (5.6)% 6.8%   WW   372 396 (6.3)% (6.8)% 0.5%     815 799 1.9% 0.4% 1.5%   OTHER INFECTIOUS DISEASES                 US   1 2 (47.9)% (47.9)% -     2 4 (51.6)% (51.6)% -   Intl   40 45 (9.6)% (12.8)% 3.2%     76 84 (9.0)% (13.7)% 4.7%   WW   41 47 (11.6)% (14.6)% 3.0%     78 88 (11.1)% (15.5)% 4.4%   CARDIOVASCULAR / METABOLISM / OTHER (CVM)                 US   765 776 (1.3)% (1.3)% -     1,499 1,631 (8.1)% (8.1)% -   Intl   124 154 (19.4)% (21.5)% 2.1%     266 312 (14.8)% (19.5)% 4.7%   WW   889 930 (4.3)% (4.7)% 0.4%     1,765 1,943 (9.2)% (9.9)% 0.7%   XARELTO                 US   664 621 7.1% 7.1% -     1,306 1,311 (0.3)% (0.3)% -   Intl   - - - - -     - - - - -   WW   664 621 7.1% 7.1% -     1,306 1,311 (0.3)% (0.3)% -   OTHER                 US   101 155 (35.0)% (35.0)% -     192 320 (39.9)% (39.9)% -   Intl   124 154 (19.4)% (21.5)% 2.1%     266 312 (14.8)% (19.5)% 4.7%   WW   225 309 (27.2)% (28.3)% 1.1%     458 632 (27.5)% (29.8)% 2.3%   TOTAL PH, ID, CVM                 US   1,878 1,895 (0.9)% (0.9)% -     3,785 3,809 (0.6)% (0.6)% -   Intl   916 952 (3.6)% (5.5)% 1.9%     1,909 1,878 1.7% (3.8)% 5.5%   WW   2,795 2,846 (1.8)% (2.4)% 0.6%     5,694 5,686 0.1% (1.7)% 1.8%   TOTAL INNOVATIVE MEDICINE                 US   9,979 9,161 8.9% 8.9% -     18,850 17,253 9.3% 9.3% -   Intl   6,405 6,041 6.0% 3.6% 2.4%     12,960 11,822 9.6% 3.9% 5.7%   WW $ 16,384 15,202 7.8% 6.8% 1.0%   $ 31,810 29,075 9.4% 7.1% 2.3%                     See footnotes at end of schedule                                     REPORTED SALES vs. PRIOR PERIOD ($MM)   REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change MEDTECH SEGMENT (2)   2026   2025   Reported   Operational (1)   Currency       2026   2025   Reported   Operational (1)   Currency                   CARDIOVASCULAR                 US $ 1,426 1,364 4.5% 4.5% -   $ 2,825 2,625 7.6% 7.6% -   Intl   978 948 3.2% 1.1% 2.1%     1,956 1,790 9.3% 5.2% 4.1%   WW   2,404 2,313 4.0% 3.1% 0.9%     4,781 4,416 8.3% 6.6% 1.7%   ELECTROPHYSIOLOGY                 US   783 741 5.8% 5.8% -     1,519 1,425 6.6% 6.6% -   Intl   749 728 2.9% 0.4% 2.5%     1,502 1,366 10.0% 5.6% 4.4%   WW   1,533 1,468 4.4% 3.1% 1.3%     3,022 2,791 8.3% 6.2% 2.1%   ABIOMED                 US   342 360 (4.8)% (4.8)% -     731 699 4.6% 4.6% -   Intl   97 89 9.5% 9.2% 0.3%     197 170 16.1% 11.4% 4.7%   WW   440 448 (2.0)% (2.0)% 0.0%     928 868 6.8% 5.9% 0.9%   SHOCKWAVE                 US   268 233 14.6% 14.6% -     510 439 16.1% 16.1% -   Intl   67 58 14.5% 15.4% (0.9)%     130 110 17.7% 17.2% 0.5%   WW   335 292 14.6% 14.7% (0.1)%     640 550 16.4% 16.3% 0.1%   OTHER CARDIOVASCULAR                 US   33 31 5.5% 5.5% -     65 63 3.1% 3.1% -   Intl   65 72 (10.5)% (13.2)% 2.7%     127 144 (11.9)% (15.3)% 3.4%   WW   98 104 (5.7)% (7.5)% 1.8%     192 207 (7.4)% (9.7)% 2.3%   SURGERY                 US   1,094 1,043 5.0% 5.0% -     2,140 2,045 4.7% 4.7% -   Intl   1,559 1,512 3.1% 0.5% 2.6%     3,024 2,906 4.1% (0.3)% 4.4%   WW   2,653 2,555 3.9% 2.3% 1.6%     5,164 4,951 4.3% 1.8% 2.5%   ADVANCED                 US   499 477 4.7% 4.7% -     976 934 4.5% 4.5% -   Intl   691 687 0.5% (1.9)% 2.4%     1,337 1,303 2.6% (1.4)% 4.0%   WW   1,189 1,164 2.2% 0.8% 1.4%     2,312 2,237 3.4% 1.0% 2.4%   GENERAL                 US   596 567 5.2% 5.2% -     1,165 1,111 4.8% 4.8% -   Intl   868 825 5.3% 2.5% 2.8%     1,687 1,603 5.2% 0.7% 4.5%   WW   1,464 1,391 5.2% 3.6% 1.6%     2,852 2,714 5.1% 2.4% 2.7%                                   See footnotes at end of schedule                                     REPORTED SALES vs. PRIOR PERIOD ($MM)   REPORTED SALES vs. PRIOR PERIOD ($MM) SECOND QUARTER SIX MONTHS % Change % Change     2026   2025   Reported   Operational (1)   Currency       2026   2025   Reported   Operational (1)   Currency   VISION                 US $ 565 557 1.4% 1.4% -   $ 1,144 1,123 1.9% 1.9% -   Intl   887 813 9.1% 8.5% 0.6%     1,672 1,526 9.6% 6.7% 2.9%   WW   1,451 1,369 6.0% 5.6% 0.4%     2,816 2,648 6.3% 4.6% 1.7%   CONTACT LENSES / OTHER                 US   445 429 3.6% 3.6% -     913 881 3.7% 3.7% -   Intl   580 536 8.1% 7.9% 0.2%     1,081 1,003 7.7% 5.0% 2.7%   WW   1,025 965 6.1% 6.0% 0.1%     1,994 1,884 5.8% 4.4% 1.4%   SURGICAL                 US   120 128 (6.0)% (6.0)% -     231 242 (4.5)% (4.5)% -   Intl   306 277 10.9% 9.6% 1.3%     591 523 13.1% 9.8% 3.3%   WW   426 403 5.6% 4.7% 0.9%     822 764 7.5% 5.3% 2.2%   ORTHOPAEDICS                 US   1,470 1,420 3.5% 3.5% -     2,905 2,804 3.6% 3.6% -   Intl   948 885 7.2% 5.3% 1.9%     1,896 1,742 8.9% 3.9% 5.0%   WW   2,418 2,305 4.9% 4.2% 0.7%     4,801 4,546 5.6% 3.7% 1.9%   HIPS                 US   283 271 4.6% 4.6% -     560 534 4.9% 4.9% -   Intl   158 150 5.5% 3.0% 2.5%     317 296 7.2% 1.7% 5.5%   WW   441 421 4.9% 4.0% 0.9%     877 830 5.7% 3.8% 1.9%   KNEES                 US   228 226 1.1% 1.1% -     467 457 2.2% 2.2% -   Intl   182 164 11.4% 10.3% 1.1%     363 322 13.0% 8.4% 4.6%   WW   410 389 5.5% 5.0% 0.5%     830 778 6.7% 4.8% 1.9%   TRAUMA                 US   536 501 6.7% 6.7% -     1,068 1,003 6.4% 6.4% -   Intl   291 267 9.2% 7.4% 1.8%     592 537 10.3% 5.2% 5.1%   WW   827 768 7.6% 6.9% 0.7%     1,660 1,540 7.8% 6.0% 1.8%   SPINE, SPORTS & OTHER                 US   423 422 0.2% 0.2% -     810 810 0.0% 0.0% -   Intl   317 305 4.0% 1.9% 2.1%     624 588 6.1% 1.3% 4.8%   WW   740 727 1.8% 0.9% 0.9%     1,434 1,398 2.6% 0.6% 2.0%   TOTAL MEDTECH                 US   4,554 4,383 3.9% 3.9% -     9,013 8,596 4.8% 4.8% -   Intl   4,372 4,158 5.2% 3.2% 2.0%     8,549 7,965 7.3% 3.2% 4.1%   WW $ 8,926 8,541 4.5% 3.6% 0.9%   $ 17,562 16,561 6.0% 4.1% 1.9%                                   Note: Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely                   * Percentage greater than 100% or not meaningful   (1) Operational growth excludes the effect of translational currency   (2) Unaudited   (3) Includes the sales of ZYTIGA which were previously disclosed separately   (4) Reported as U.S. sales   (5) Acquired with Intra-Cellular Therapies on April 2, 2025   Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions Quarter to Date Innovative Medicine Second Quarter June 28, 2026
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Second Quarter June 28, 2026
Non-GAAP Cost of products sold $ 4,296   (764 ) (18 ) (9 ) 3,505   Selling, marketing and admin expenses   3,130   3,130   Research and development expense   2,875   2,875   Other segment items   (166 ) 91   (182 ) (54 ) 227   (84 ) Adjusted Income Before Tax by Segment   6,249   764   (91 ) 200   63   (227 ) -   -   6,958     MedTech Second Quarter June 28, 2026
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Second Quarter June 28, 2026
Non-GAAP Cost of products sold $ 3,737   (481 ) (17 ) (3 ) 3,236   Selling, marketing and admin expenses   3,069   (17 ) 3,052   Research and development expense   778   (2 ) 776   Other segment items   165   76   (59 ) (37 ) (14 ) (236 ) (105 ) Adjusted Income Before Tax by Segment   1,177   481   (76 ) 76   37   14   258   -   1,967     Expenses not allocated to segments Second Quarter June 28, 2026
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Second Quarter June 28, 2026
Non-GAAP Cost of products sold $ 18   18   Selling, marketing and admin expenses   233   233   Research and development expense   -   -   Other segment items   428   (434 ) 20   14   Adjusted Income Before Tax by Segment   (679 ) -   434   -   (20 ) -   -   -   (265 )   Johnson & Johnson Consolidated Second Quarter June 28, 2026
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Second Quarter June 28, 2026
Non-GAAP Cost of products sold $ 8,051   (1,245 ) (35 ) (9 ) (3 ) 6,759   Selling, marketing and admin expenses   6,432   (17 ) 6,415   Research and development expense   3,653   (2 ) 3,651   Other (Income) / Expense   331   (267 ) (207 ) (71 ) 213   (236 ) (237 ) In-process research and development impairments   -   -   Interest (Income)/Expense   62   62   Restructuring   34   (34 ) -   Adjusted Income Before Tax   6,747   1,245   267   276   80   (213 ) 258   -   8,660   Provision for taxes on income   1,213   239   59   54   23   (50 ) 43   (2 ) 1,579   Net Earnings $ 5,534   1,006   208   222   57   (163 ) 215   2   7,081   Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions Quarter to Date Innovative Medicine Second Quarter June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Second Quarter June 29, 2025
Non-GAAP Cost of products sold $ 3,978   (785 ) (13 ) 3,180   Selling, marketing and admin expenses   2,789   2,789   Research and development expense   2,869   2,869   Other segment items   14   69   (207 ) 8   (13 ) (129 ) Adjusted Income Before Tax by Segment   5,552   785   (69 ) -   220   (8 ) -   13   6,493     MedTech Second Quarter June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Second Quarter June 29, 2025
Non-GAAP Cost of products sold $ 3,638   (482 ) (15 ) 1   3,142   Selling, marketing and admin expenses   2,862   2,862   Research and development expense   647   43   690   Other segment items   190   (83 ) (64 ) (53 ) (29 ) (14 ) (53 ) Adjusted Income Before Tax by Segment   1,204   482   83   79   9   29   -   14   1,900     Expenses not allocated to segments Second Quarter June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Second Quarter June 29, 2025
Non-GAAP Cost of products sold $ 12   12   Selling, marketing and admin expenses   238   238   Research and development expense   -   -   Other segment items   15   (43 ) (17 ) (45 ) Adjusted Income Before Tax by Segment   (265 ) -   43   -   17   -   -   -   (205 )   Johnson & Johnson Consolidated Second Quarter June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Second Quarter June 29, 2025
Non-GAAP Cost of products sold $ 7,628   (1,267 ) (15 ) (12 ) 6,334   Selling, marketing and admin expenses   5,889   5,889   Research and development expense   3,516   43   3,559   Other (Income) / Expense   107   (57 ) (277 ) (21 ) (27 ) (275 ) In-process research and development impairments   -   -   Interest (Income)/Expense   48   48   Restructuring   64   (64 ) -   Adjusted Income Before Tax   6,491   1,267   57   79   246   21   -   27   8,188   Provision for taxes on income   954   222   9   13   72   5   214   -   1,489   Net Earnings $ 5,537   1,045   48   66   174   16   (214 ) 27   6,699   Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions Year to Date Innovative Medicine Six Months June 28, 2026
GAAP Intangible asset amortization Litigation related In-process research and development impairments Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Six Months June 28, 2026
Non-GAAP Cost of products sold $ 8,686   (1,527 ) (18 ) (19 ) 7,122   Selling, marketing and admin expenses   6,048   6,048   Research and development expense   5,688   5,688   Other segment items   (178 ) 51   (182 ) (100 ) 282   (127 ) Adjusted Income Before Tax by Segment   11,566   1,527   (51 ) -   200   119   (282 ) -   -   13,079     MedTech Six Months June 28, 2026
GAAP Intangible asset amortization Litigation related In-process research and development impairments Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Six Months June 28, 2026
Non-GAAP Cost of products sold $ 7,438   (965 ) (42 ) (3 ) 6,428   Selling, marketing and admin expenses   5,975   (17 ) 5,958   Research and development expense   1,492   (2 ) 1,490   Other segment items   241   117   (36 ) (96 ) (64 ) (10 ) (355 ) (203 ) Adjusted Income Before Tax by Segment   2,416   965   (117 ) 36   138   64   10   377   -   3,889     Expenses not allocated to segments Six Months June 28, 2026
GAAP Intangible asset amortization Litigation related In-process research and development impairments Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Six Months June 28, 2026
Non-GAAP Cost of products sold $ 33   33   Selling, marketing and admin expenses   443   443   Research and development expense   -   -   Other segment items   769   (765 ) 7   11   Adjusted Income Before Tax by Segment   (1,245 ) -   765   -   -   (7 ) -   -   -   (487 )   Johnson & Johnson Consolidated Six Months June 28, 2026
GAAP Intangible asset amortization Litigation related In-process research and development impairments Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Orthopaedics Separation Related Tax legislation and other tax related Six Months June 28, 2026
Non-GAAP Cost of products sold $ 16,157   (2,492 ) (60 ) (19 ) (3 ) 13,583   Selling, marketing and admin expenses   12,466   (17 ) 12,449   Research and development expense   7,180   (2 ) 7,178   Other (Income) / Expense   625   (597 ) (212 ) (157 ) 272   (355 ) (424 ) In-process research and development impairments   36   (36 ) -   Interest (Income)/Expense   105   105   Restructuring   66   (66 ) -   Adjusted Income Before Tax   12,737   2,492   597   36   338   176   (272 ) 377   -   16,481   Provision for taxes on income   1,968   479   131   8   124   45   (63 ) 68   26   2,786   Net Earnings $ 10,769   2,013   466   28   214   131   (209 ) 309   (26 ) 13,695   Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions Year to Date Innovative Medicine Six Months June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Six Months June 29, 2025
Non-GAAP Cost of products sold $ 7,998   (1,434 ) (13 ) 6,551   Selling, marketing and admin expenses   5,050   5,050   Research and development expense   5,417   5,417   Other segment items   (152 ) -   69   (227 ) (10 ) (13 ) (333 ) Adjusted Income Before Tax by Segment   10,762   1,434   (69 ) -   240   10   -   13   12,390     MedTech Six Months June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Six Months June 29, 2025
Non-GAAP Cost of products sold $ 6,964   (953 ) (23 ) (51 ) 5,937   Selling, marketing and admin expenses   5,518   5,518   Research and development expense   1,324   37   1,361   Other segment items   130   (83 ) (111 ) (107 ) (50 ) (14 ) (235 ) Adjusted Income Before Tax by Segment   2,625   953   83   134   121   50   -   14   3,980     Expenses not allocated to segments Six Months June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Six Months June 29, 2025
Non-GAAP Cost of products sold $ 23   23   Selling, marketing and admin expenses   433   433   Research and development expense   -   -   Other segment items   (7,191 ) 6,923   (17 ) (285 ) Adjusted Income Before Tax by Segment   6,735   -   (6,923 ) -   17   -   -   -   (171 )   Johnson & Johnson Consolidated Six Months June 29, 2025
GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Six Months June 29, 2025
Non-GAAP Cost of products sold $ 14,985   (2,387 ) (23 ) (64 ) 12,511   Selling, marketing and admin expenses   11,001   11,001   Research and development expense   6,741   37   6,778   Other (Income) / Expense   (7,214 ) 6,909   (30 ) (351 ) (60 ) (27 ) (773 ) In-process research and development impairments   -   -   Interest (Income)/Expense   (80 ) (80 ) Restructuring   81   (81 ) -   Adjusted Income Before Tax   20,122   2,387   (6,909 ) 134   378   60   -   27   16,199   Provision for taxes on income   3,586   410   (1,544 ) 24   102   14   202   2,794   Net Earnings $ 16,536   1,977   (5,365 ) 110   276   46   (202 ) 27   13,405     View source version on businesswire.com: https://www.businesswire.com/news/home/20260715519699/en/ Media contact:
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investor-relations@its.jnj.com Original: Johnson & Johnson reports Q2 2026 results, raises 2026 outlook

Johnson & Johnson Announces Quarterly Dividend for Third Quarter 2026July 15, 2026 6:25 AM
Business Wire Johnson & Johnson (NYSE: JNJ) today announced that its Board of Directors has declared a cash dividend for the third quarter of 2026 of $1.34 per share on the company’s common stock. The dividend is payable on September 8, 2026 to shareholders of record at the close of business on August 25, 2026. The ex-dividend date is August 25, 2026. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. View source version on businesswire.com: https://www.businesswire.com/news/home/20260715074611/en/ Media contact:
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investor-relations@its.jnj.com Original: Johnson & Johnson Announces Quarterly Dividend for Third Quarter 2026

Psychedelics guidance from the FDA set to benefit developers, including AtaiBeckley, Jefferies says

https://www.proactiveinvestors.com/companies/news/1095364/psychedelics-guidance-from-the-fda-set-to-benefit-developers-including-ataibeckley-jefferies-says-1095364.html

JNJ Possible to be in talks with ATAI...

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations

Wall Street Set for Softer Open as Oil Spike and Middle East Tensions Weigh on Sentiment: Dow Jones, S&P, Nasdaq, FuturesJuly 13, 2026 9:22 AM
IH Market News Futures Point Lower Ahead of Monday’s Session U.S. stock futures indicated a weaker start to Monday’s trading, with investors expected to take some profits after last week’s strong gains as geopolitical tensions and rising oil prices weighed on market sentiment. The latest pressure comes after renewed military exchanges between the United States and Iran intensified concerns about global energy supplies and broader economic risks. Oil Prices Jump Following Fresh Military Action Crude oil prices surged after the U.S. Central Command confirmed it had carried out another round of precision strikes against multiple Iranian targets on Sunday. Iran responded with attacks targeting several Gulf nations, including Bahrain, Kuwait, Qatar, Jordan and Oman, adding further strain to an already fragile ceasefire. Conflicting statements from Washington and Tehran over the operational status of the Strait of Hormuz also fuelled uncertainty, helping push U.S. crude futures more than 4% higher. Chip Stocks Add Pressure Technology shares were also expected to face headwinds after a sharp decline in SK Hynix (USOTC:HXSCL). The South Korean memory chipmaker’s U.S.-listed shares dropped more than 9% in premarket trading after soaring more than 13% during their Nasdaq debut last Friday, creating fresh pressure across the semiconductor sector. Investors Await Key Economic Data and Earnings Despite the cautious tone, investors may avoid making aggressive moves before several important catalysts later this week. Major U.S. banks including Bank of America (NYSE:BAC), Citigroup (NYSE:C), Goldman Sachs (NYSE:GS), JPMorgan Chase (NYSE:JPM) and Wells Fargo (NYSE:WFC) are scheduled to report quarterly earnings, alongside Johnson & Johnson (NYSE:JNJ), UnitedHealth (NYSE:UNH) and Netflix (NASDAQ:NFLX). Market participants are also awaiting fresh U.S. inflation data, which could shape expectations for the Federal Reserve’s next interest-rate decision. Daniela Hathorn, Senior Market Analyst at Capital.com, said, “Following stronger inflation readings earlier this year and a resilient labour market, investors are keen to determine whether underlying price pressures remain persistent despite the recent fall in energy prices.” She added, “A hotter-than-expected reading would reinforce the higher-for-longer narrative and could add further support to the dollar and bond yields. Conversely, a softer report would help offset some of the inflation concerns stemming from renewed geopolitical tensions and could provide equities with a much-needed boost.” Strong Finish to Last Week Wall Street ended Friday on a positive note despite a subdued trading session. The Dow Jones Industrial Average rose 149.60 points, or 0.3%, to 52,637.01. The Nasdaq Composite gained 74.72 points, or 0.3%, to finish at 26,281.61, while the S&P 500 advanced 31.75 points, or 0.4%, to 7,575.39. For the week, the Nasdaq climbed 1.7%, the S&P 500 added 1.2% and the Dow advanced 0.5%. Technology stocks helped lead those gains, with Meta Platforms (META) rising 6% after Bank of America reaffirmed its Buy rating, while Nvidia (NASDAQ:NVDA) gained 4%. U.S.-listed shares of SK Hynix also surged 13.1% during their first day of trading. Sector Performance Was Mixed Biotechnology companies underperformed on Friday, pulling the NYSE Arca Biotechnology Index down 2.6%. Airline stocks also came under pressure, with the NYSE Arca Airline Index declining 2.2%. In contrast, housing stocks outperformed, lifting the Philadelphia Housing Sector Index 1.5%, while oil service companies gained ground, with the Philadelphia Oil Service Index rising 1.4%. SK Hynix stock price Nvidia stock price Bank of America stock price Citigroup stock price Goldman Sachs Group stock price JPMorgan Chase stock price Wells Fargo stock price Johnson & Johnson stock price UnitedHealth Group stock price Netflix stock priceThe post Wall Street Set for Softer Open as Oil Spike and Middle East Tensions Weigh on Sentiment: Dow Jones, S&P, Nasdaq, Futures appeared first on US Editors. Original: Wall Street Set for Softer Open as Oil Spike and Middle East Tensions Weigh on Sentiment: Dow Jones, S&P, Nasdaq, Futures

U.S. Futures Drift as Investors Await Earnings Season and Inflation Data: Dow Jones, S&P, NasdaqJuly 10, 2026 9:31 AM
IH Market News U.S. stock futures traded little changed on Friday as investors paused after Thursday’s technology-led rally, shifting their attention toward next week’s corporate earnings reports and key inflation releases. With few major economic reports scheduled before the weekend, market participants appeared reluctant to establish significant new positions, instead focusing on the outlook for corporate profits and monetary policy. Earnings Season Moves Into Focus The second-quarter reporting season is set to begin in earnest next week, with several of the largest U.S. financial institutions due to release results. Among the companies scheduled to report are Bank of America (NYSE:BAC), Citigroup (NYSE:C), Goldman Sachs (NYSE:GS), JPMorgan Chase (NYSE:JPM), Wells Fargo (NYSE:WFC), Johnson & Johnson (NYSE:JNJ), UnitedHealth (NYSE:UNH) and Netflix (NASDAQ:NFLX). Daniela Hathorn, Senior Market Analyst at Capital.com, believes investors will pay close attention to the quality of corporate earnings rather than headline numbers alone. “Investors will be looking for confirmation that AI-related investment continues to translate into robust earnings growth and resilient margins, particularly among the large technology companies that have driven much of this year’s rally,” she said. She added, “With valuations still elevated, earnings guidance could prove just as important as the headline results themselves.” Technology Stocks Extend Their Momentum Wall Street finished Thursday with solid gains, led once again by technology shares. The Nasdaq Composite climbed 1.3% to close at 26,206.89, while the S&P 500 advanced 0.8% to 7,543.64. The Dow Jones Industrial Average added 0.3%, ending the session at 52,487.41. Investor sentiment received support from reports that the U.S. listing of South Korean memory-chip maker SK Hynix (USOTC:HXSCL) attracted exceptionally strong demand ahead of its market debut. Micron Technology (NASDAQ:MU) also outperformed after announcing plans to invest as much as $3 billion to expand semiconductor manufacturing capacity and strengthen the U.S. chip supply chain. Oil Pullback Eases Inflation Concerns A decline in crude oil prices also improved market sentiment. U.S. oil futures retreated by more than 2% after posting strong gains during the previous two sessions, as traders judged that recent military exchanges between the United States and Iran were unlikely to develop into a broader regional conflict. President Donald Trump said Iran wants to “make a deal so badly,” while warning that further attacks on commercial shipping would prompt a stronger U.S. response. The comments followed additional U.S. military operations targeting Iranian assets and reports of retaliatory strikes against Bahrain, Kuwait and Qatar. Hardware and Gold Stocks Lead Sector Performance Technology remained one of the market’s strongest-performing sectors, with computer hardware and semiconductor companies posting notable gains. Gold mining shares also advanced as bullion prices recovered from recent weakness. By contrast, energy stocks lagged the broader market after the retreat in oil prices reduced support for the sector. Bank of America stock price Citigroup stock price Goldman Sachs Group stock price JPMorgan Chase stock price Wells Fargo stock price Johnson & Johnson stock price UnitedHealth Group stock price Netflix stock price SK Hynix stock price Micron Technology stock priceThe post U.S. Futures Drift as Investors Await Earnings Season and Inflation Data: Dow Jones, S&P, Nasdaq appeared first on US Editors. Original: U.S. Futures Drift as Investors Await Earnings Season and Inflation Data: Dow Jones, S&P, Nasdaq

Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF PlatformJuly 8, 2026 7:45 AM
Business Wire Dual Energy THERMOCOOL SMARTTOUCH SF Platform brings pulse field and radiofrequency energy together in a single catheter. Integrated with the CARTO ecosystem, the platform gives physicians greater versatility to tailor treatment based on patient anatomy and case complexity.i Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) approved the Dual Energy THERMOCOOL SMARTTOUCH SF Platform (DE STSF), an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through a single catheter.i This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708094213/en/Dual Energy THERMOCOOL SMARTTOUCH SF Catheter “The FDA approval of the Dual Energy THERMOCOOL SMARTTOUCH SF Platform is another important milestone in what has been an incredible pace of innovation for our business,” said Michael Bodner, Company Group Chair, Electrophysiology & Neurovascular, MedTech, Johnson & Johnson. “Our goal has always been to put the best possible technologies into physicians’ hands so they can treat increasingly complex cases with confidence. Following a successful introduction in Europe, we’re pleased to rapidly expand access to this technology in the U.S. and continue building on the momentum of one of the most active innovation periods in our history.” Built on the THERMOCOOL SMARTTOUCH SF Platform, which has extensive clinical validation and has treated over one million patients in the U.S., the DE STSF Platform brings pulse field capability to a catheter physicians know and trust.i The DE STSF platform is integrated with the CARTO ecosystem, including advanced mapping, imaging and PF Index guidance, helping physicians confidently deliver energy with precise contact force while supporting a predictable procedure and reproducible workflow. The dual energy capability gives physicians the versatility to use RF or PF energy based on patient anatomy and case complexity.i "Electrophysiologists need technologies that support different anatomies, substrates, workflows and treatment goals," said Dhanunjaya (DJ) Lakkireddy1, M.D., FHRS, MBA, Executive Medical Director, The Kansas City Heart Rhythm Institute. "The Dual Energy THERMOCOOL SMARTTOUCH SF Platform gives electrophysiologists the choice to use RF or PF energy based on the needs of each procedure. Having both capabilities integrated in the CARTO system can help us adapt our approach for more complex cases and plan procedures with greater confidence.” Following FDA approval, first U.S. procedures with the DE STSF Platform are expected to begin this summer as Johnson & Johnson initiates a phased commercial rollout. About Cardiovascular Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit this website. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at https://www.jnjmedtech.com/. Follow us at @JNJMedTech and on LinkedIn. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Dual Energy THERMOCOOL SMARTTOUCH SF. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson and its affiliates 2026. All rights reserved. US_ELP_THER_418584 _______________________________________ 1 Dr. Lakkireddy serves as a consultant for Johnson & Johnson. Dr. Lakkireddy was not compensated for this authorship contribution.     i Mattias Duytschaever, Gediminas Rackauskas, Tom De Potter, et al. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results EP Europace, Volume 26, Issue 5, May 2024, euae088, ttps://doi.org/10.1093/europace/euae088   View source version on businesswire.com: https://www.businesswire.com/news/home/20260708094213/en/ Media:
Maria Jose Echeverria
MEchever@ITS.JNJ.com Erin Farley
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investor-relations@its.jnj.com Original: Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform

Johnson & Johnson presents new IMAAVY® (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravisJune 26, 2026 12:35 PM
PR Newswire (US) New analyses from the Phase 3 Vivacity-MG3 study support the impact of IMAAVY in anti-AChR+a, anti-MuSK+b adult patients with generalized myasthenia gravis (gMG) including those early in their disease, participants with lower symptom burden and those who experienced common infectionsTo address an important evidence gap, the PETUNIAc study design will be presented – demonstrating the innovative way pregnancy outcomes data will be collected following treatment with IMAAVY IMAAVY, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with generalized myasthenia gravis (gMG)GENEVA, June 26, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data across 12 abstracts at the European Academy of Neurology (EAN) 2026 Congress that offer additional insight into the use of IMAAVY® (nipocalimab-aahu) throughout clinically relevant points in the generalized myasthenia gravis (gMG) treatment journey. The analyses include adults with anti-AChRa or anti-MuSKb antibody-positive gMG who were early in their disease course or had lower baseline symptom burden – providing insight into the potential importance of addressing pathogenic immunoglobulin G (IgG) early in disease progression where use of advanced therapies may be less common.1,2 Additional research to be shared include outcomes shortly after common infections, which are a known cause of disease exacerbations in gMG, and plans to address evidence gaps in use of IMAAVY during pregnancy.3,4 "For many people living with generalized myasthenia gravis, achieving and maintaining sustained disease control is an important goal throughout the course of their disease, from the moment they are diagnosed and across the different stages of their journey," said Carlo Antozzi, M.D., Neurological Institute Foundation C. Besta of Milan, Italy.d "These post-hoc analyses add to the growing body of evidence on IMAAVY, which is designed to selectively target and bind the neonatal Fc receptor with high affinity, and reduce pathogenic immunoglobulin G autoantibodies associated with generalized myasthenia gravis."Post-hoc analyses from the pivotal Vivacity-MG3 study in adults with antibody positive gMG (spanning anti-AChR+ and anti-MuSK+) will be presented which provide new insights that could inform clinical care including:Patients early in their disease course (within five years of diagnosis) show improved outcomes: IMAAVY plus standard of care (SOC) showed greater reductions in MG-ADLe scores versus placebo plus SOC (-4.9 vs. -2.7) at Week 24, with a greater proportion of patients receiving IMAAVY also achieving the stringent measure of sustained meaningful clinical improvement (MCI)f for ≥20 weeks compared to placebo.1,5 IMAAVY is the only FcRn blocker evaluated to demonstrate sustained MCI over this duration in the double-blind phase of its pivotal study.5,gPatients with lower baseline symptom burden sustain MCI: IMAAVY plus SOC decreased symptom severityh and improved daily functioning at Week 24 versus placebo plus SOC (MG-ADL scores of -4.5 vs. -2.3).2 A greater proportion of patients receiving IMAAVY also achieved sustained MCI in this setting, adding further insights for healthcare professionals into the use of IMAAVY in patients with less severe disease.6,iPatients maintain control after contracting common infections: In the IMAAVY arm, observed symptom improvements were maintained within two weeks after patients contracted common infections, providing data on the use of IMAAVY after periods when the likelihood of disease exacerbations is elevated.3,j,kSafety and tolerability were consistent across all patients in the study and across other nipocalimab studies.7,8,9  The overall incidence of adverse events (AEs) was 84% in both the IMAAVY and the placebo arms and serious adverse events (SAEs) were 9% in the IMAAVY arm compared to 14% in the placebo arm.7,kOngoing evidence generation in gMG will also be highlighted, including:Innovative PETUNIA study design: PETUNIA is designed to generate real-world safety data on pregnancy, maternal, and infant outcomes following exposure to IMAAVY during pregnancy.4 By leveraging prospective and retrospective reports the study aims to capture more detailed information on outcomes in this setting, helping to expand the evidence base beyond the traditional post-marketing safety monitoring requirements and support clinical decision-making in an area where current evidence is limited.4,c"People living with generalized myasthenia gravis often face unpredictable symptoms that can interfere with everyday life, underscoring the need for continued innovation grounded in disease biology," said David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "At Johnson & Johnson, we are committed to advancing research in autoantibody diseases to better understand the role of IMAAVY, an FcRn blocker designed to help address the underlying cause of generalized myasthenia gravis, while preserving humoral immune function. We are continuing to explore the potential of IMAAVY in supporting sustained disease control across key moments in patients' lives."The full list of accepted Johnson & Johnson abstracts can be found HERE.IMAAVY is approved for adult and pediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody positive gMG by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).10,11Editor's Notes:
a. Anti-AChR+= anti-acetylcholine receptor positive antibody.
b. Anti-MuSK+= anti-muscle specific tyrosine kinase positive antibody.
c. Pregnancy Enhanced Tracking with Neonatal and Infant Assessment (PETUNIA) is a post-marketing FDA requirement.
d. Dr. Carlo Antozzi has provided consulting, advisory and speaking services to Johnson & Johnson. He has not been paid for any media work.
e. MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.12
f.  The proportion of patients achieving a meaningful clinical improvement [MCI] is defined as a ≥2-point improvement in MG-ADL score at Week 24.1,2
g.  At Week 24, patients diagnosed within five years who were treated with IMAAVY plus standard of care (SOC) achieved greater reductions in MG-ADL scores from baseline compared with placebo plus SOC (mean [SD]: -4.9 [2.88] vs -2.7 [2.46]; difference: -2.22 [standard error (SE): 0.76]; p=0.005).1
h. This is based on QMG (Quantitative Myasthenia Gravis) score which is a 13-item assessment by a clinician that quantifies MG disease severity through muscle weakness. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.12
i.  At Week 24, patients with MG-ADL scores lower than 9 treated with IMAAVY plus SOC achieved greater reductions in MG-ADL scores from baseline compared with placebo plus SOC (mean [SD]: -4.5 [2.64] vs -2.3 [2.37]; difference: -2.23 [SE: 0.588]; p

New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myelomaJune 13, 2026 6:33 AM
PR Newswire (US) TALVEY® plus DARZALEX FASPRO® with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 monthsMonumenTAL-3 is the third positive study in recent months from Johnson & Johnson's bispecific portfolio and is the first Phase 3 study of a GPRC5D bispecific investigational combinationResults reinforce Johnson & Johnson's leadership in multiple myeloma, advancing bispecific combinations earlier in the treatment journey, and expanding options to match the right treatment to the right patient and stage of diseaseSTOCKHOLM, June 13, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced results from the investigational Phase 3 MonumenTAL-3 study showing that TALVEY® (talquetamab-tgvs), a GPRC5D bispecific antibody, in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72% and clinically meaningful reduction of up to 53% in the risk of death compared to the standard regimen of DARZALEX FASPRO®, pomalidomide, and dexamethasone (DPd) in patients with relapsed/refractory multiple myeloma (RRMM).1 Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.1   This is the first Phase 3 study to demonstrate superior PFS with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma, underscoring the potential of this regimen to advance bispecific combinations earlier in the treatment paradigm.1 Results were presented at the 2026 European Hematology Association (EHA) Annual Meeting (Abstract #S100), with simultaneous publication in The New England Journal of Medicine.Expert and company perspectives support bispecific combinations in earlier lines
"The impressive results from this study point to the promise of TALVEY plus DARZALEX FASPRO as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma," said Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.* "TALVEY works with DARZALEX FASPRO in earlier lines—a critical time for treating patients with the most effective regimens.""The MonumenTAL-3 findings underscore our commitment to bringing bispecific combinations into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson's multiple myeloma portfolio," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson. "These results add to our growing body of evidence across bispecific antibodies and reinforce our strategy of advancing differentiated immunotherapies to better match the right therapy to the right patient at each stage of disease."Novel mechanism spares healthy immune cells
TALVEY ® targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body).2 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-Cells.2 TALVEY® works by targeting myeloma cells while largely sparing healthy B-cells.2Phase 3 MonumenTAL-3 study results
The MonumenTAL-3 study evaluated TALVEY® with DARZALEX FASPRO® (Tal-D) or TALVEY® with DARZALEX FASPRO® and pomalidomide (Tal-DP) compared to DPd in patients with RRMM who have received at least one prior line of therapy.1 At a median follow-up of two years (24.6 months), results showed significant improvement in PFS for Tal-DP (hazard ratio [HR], 0.28; 95 percent confidence interval [CI], 0.20-0.40; p

Johnson & Johnson Reports Strong Late-Stage Results for Rare Blood Disorder Therapy (JNJ)June 11, 2026 8:40 AM
IH Market News Johnson & Johnson (NYSE:JNJ) has announced positive findings from its Phase 2/3 ENERGY clinical trial, with IMAAVY (nipocalimab-aahu) demonstrating statistically significant improvements in hemoglobin levels among patients with warm autoimmune hemolytic anemia compared with placebo. The results provide further support for the therapy as the company seeks regulatory approval for a condition that currently has no FDA-approved treatment options. Trial Meets Primary Endpoint The randomized, placebo-controlled study showed that patients receiving the 30 mg/kg dose of IMAAVY achieved sustained hemoglobin improvements at roughly three times the rate observed in the placebo group after 24 weeks of treatment. Patients treated with the therapy also experienced an average hemoglobin increase of at least 1 g/dL as early as the first week of treatment. The trial’s primary endpoint focused on durable hemoglobin improvement, defined as an increase of at least 2 g/dL from baseline and a hemoglobin concentration of at least 10 g/dL across three visits over a 28-day period beginning by Week 16, without the need for rescue therapy or adjustments to background medications. Significant Improvement in Patient Outcomes According to the study results, nearly two-thirds of patients receiving the 30 mg/kg dose achieved both a hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dL from baseline by Week 24. Beyond improvements in hemoglobin levels, the treatment was also associated with reduced fatigue and lower reliance on steroid therapy, both important measures for patients living with the disease. The findings suggest that IMAAVY could provide meaningful clinical benefits for individuals affected by the rare autoimmune condition. Safety Profile Remains Consistent Johnson & Johnson reported that IMAAVY’s safety profile in the study was consistent with its approved use in patients with generalized myasthenia gravis. Among patients with warm autoimmune hemolytic anemia, the most frequently reported adverse events were peripheral edema, diarrhea and fever, each occurring in at least 10% of treated participants. The company indicated that no new safety concerns were identified during the trial. Regulatory Review Underway Warm autoimmune hemolytic anemia is a rare and potentially life-threatening disease in which the immune system destroys red blood cells, leading to anemia and other serious complications. Currently, there are no FDA-approved therapies specifically indicated for the condition. Johnson & Johnson has already submitted a supplemental Biologics License Application for IMAAVY, and the treatment has been granted Priority Review status by the U.S. Food and Drug Administration. Data Presented at Major Hematology Conference The results from the ENERGY study were presented at the European Hematology Association 2026 Congress, according to the company. The positive data strengthen Johnson & Johnson’s position in rare disease treatment and could support the expansion of IMAAVY into an additional therapeutic indication if regulatory approval is secured. Johnson & Johnson stock price Original: Johnson & Johnson Reports Strong Late-Stage Results for Rare Blood Disorder Therapy (JNJ)

Johnson & Johnson Expands U.S. Availability of TECNIS PureSee IOL, an Advanced Lens Option for Cataract Surgeons and PatientsJune 11, 2026 7:45 AM
Business Wire Expanded U.S. availability paired with new patient lifestyle quiz encourages informed decision-making ahead of cataract surgery. Cataracts are one of the leading causes of vision impairment.1 Nearly 20% of Americans aged 40+ live with cataracts that make everyday tasks more challenging, yet only 5% have had cataract surgery.2 Over half a million eyes worldwide have already experienced clearer, extended range of vision with TECNIS PureSee IOL after cataract surgery.3,4 97% of patients would recommend TECNIS PureSee IOL to friends or family.5 Johnson & Johnson (NYSE: JNJ) is expanding the U.S. roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC-IOLs). TECNIS PureSee IOL is an extended depth of focus (EDOF) lens designed to support visual clarity and quality for patients undergoing cataract surgery.3 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611210092/en/ Benefits of TECNIS PureSee IOL: Range of vision: Excellent distance and intermediate vision with some near vision3* Low level of bothersome visual symptoms: 97% of patients reported no very bothersome visual disturbances3 Vibrant vision: Excellent vision, day and night3 “With the full U.S. availability of TECNIS PureSee IOL, we are expanding access to an important extended depth of focus option that reflects our commitment to innovation, visual quality, and patient satisfaction,”3 said Erin Powers, President, Surgical Vision, North America, Johnson & Johnson. “Patients today want vision solutions that support how they live their lives every day. TECNIS PureSee IOL builds on the trusted TECNIS platform to help meet those expectations while giving surgeons greater flexibility to personalize care.” The expanded U.S. availability of TECNIS PureSee IOL comes during Cataract Awareness Month, a time dedicated to raising awareness about this common and preventable cause of vision loss. Cataract surgery is one of the most common and safe procedures in the U.S., with a success rate of nearly 98%.6 In a single procedure, TECNIS PureSee IOL addresses both cataract-related vision loss and the effects of presbyopia,3 which occurs when your eyes gradually lose the ability to see objects clearly up close.7 Nearly everyone will get presbyopia by the age of 50.8 TECNIS PureSee IOL is the first and only U.S. FDA-approved extended depth of focus (EDOF) IOL with no warning on loss of contrast sensitivity.3** Contrast sensitivity refers to a patient’s ability to distinguish an object from its background, an important part of visual quality, especially in low-light or foggy conditions. Aspheric monofocal IOLs are widely considered the benchmark for preserving contrast sensitivity. By maintaining contrast sensitivity comparable to an aspheric monofocal IOL, TECNIS PureSee IOL helps patients experience the visual clarity and confidence they expect, while also benefiting from an extended range of vision.3 “I was an investigator with the TECNIS PureSee IOL, so I have firsthand experience with this lens, and I’m excited to have this option in my practice for patients,” said Daniel Chang, MD, Cataract and Refractive Surgeon, Empire Eye & Laser Center.^ “This is the first presbyopia-correcting lens I’ve seen that has similar, if not in some cases even fewer, night vision symptoms than a monofocal lens.3 This is a very exciting time for the TECNIS platform. I think TECNIS PureSee IOL is going to be a landmark advancement.” New patient lifestyle quiz To further support patient education during Cataract Awareness Month, Johnson & Johnson is encouraging individuals to take a new patient lifestyle quiz designed to help them reflect on their daily activities, vision needs, and goals ahead of cataract surgery. Patients can use the quiz as a starting point for informed conversations with their eye care professional about which TECNIS IOL, including the TECNIS PureSee IOL, may be right for them. For more patient information and tools please visit www.clearvisionforyou.com. Visit us at jnjvisionpro.com/en-us/ and follow Johnson & Johnson | Vision on LinkedIn. INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS PureSee™ IOL and TECNIS PureSee™ Toric II IOLs with TECNIS SIMPLICITY™ Delivery System Rx Only INDICATIONS FOR USE The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only. WARNINGS Physicians should weigh the potential benefit/risk ratio of IOL implantation in patients with any of the conditions listed below, as intraocular lenses may exacerbate an existing condition or may pose an unreasonable risk to the eyesight of patients. The following conditions are not specific to the design of the IOL and are attributed to cataract surgery and/or IOL implantation in general: Recurrent severe anterior or posterior segment inflammation of unknown etiology Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss) Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible Risk of damage to the endothelium during implantation Suspected microbial infection Congenital bilateral cataracts Previous history of, or a predisposition to, retinal detachment Potentially good vision in only one eye Medically uncontrollable glaucoma Corneal endothelial dystrophy Proliferative diabetic retinopathy Rotation of the toric lens away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the delivery system is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second) during initial lens advancement. Doing so may result in improper folding of the lens. Do not advance the lens from the Holding Position prior to fully hydrating the system. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to prevent sticking and a potential scratch or crack to the lens. Do not advance the lens from the Holding Position until ready for implantation. Interruptions during delivery may result in the lens being scratched or cracked or stuck in the cartridge. Discard the device if the lens has been advanced past the Holding Position but not delivered within 60 seconds. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Johnson & Johnson Surgical Vision, Inc., single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient contamination, transmission of infection, and lack of product sterility. PRECAUTIONS Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended. This is a single-use device. Do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material of the IOL and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F (35°C). Do not autoclave the delivery system. The contents are sterile unless the package is opened or damaged. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/or the lens may have been compromised. The recommended temperature for implanting the lens is at least 63°F (17°C). Do not advance the lens unless ready for lens implantation. Do not leave the lens in a folded position more than 10 minutes. When the delivery system is used improperly, the lens may not be delivered properly (i.e., haptics may be broken). Please refer to the specific Directions For Use section provided. The use of balanced salt solution or ophthalmic viscosurgical devices (OVDs) is required when using the delivery system. For optimal performance when using OVD, use the HEALON™ family of OVDs. The use of balanced salt solution with additives has not been studied for this product. The lens should be placed entirely in the capsular bag. The lens should not be placed in the ciliary sulcus. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the toric lens with the intended axis of placement. Do not reuse. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. The IOL is designed for optimum visual performance when emmetropia is targeted. The TECNIS™ Toric IOL Calculator includes a feature that accounts for posterior corneal astigmatism (PCA). The PCA is based on an algorithm that combines published literature (Koch, et al., 2012) and a retrospective analysis of data from a TECNIS™ Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in the prospective TECNIS™ Toric IOL U.S. IDE study and may yield results different from those in the TECNIS PureSee™ Toric II IOL labeling. Please refer to the TECNIS™ Toric IOL Calculator user manual for more information. The use of methods other than the TECNIS™ Toric IOL Calculator to select cylinder power and appropriate axis of implantation were not assessed in the TECNIS™ Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS™ Toric IOL Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes for the TECNIS PureSee™ Toric II IOLs. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, the surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The effectiveness of the toric lens in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism less than 1.0 diopter has not been demonstrated. All corneal incisions were placed temporally in the TECNIS™ Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained for the TECNIS™ Toric IOL. Note that the TECNIS™ Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Children under the age of 2 years are not suitable candidates for intraocular lenses. The safety and effectiveness of the TECNIS PureSee™ IOLs have not been substantiated in pregnant women, patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Before Surgery Pupil abnormalities Prior corneal refractive or intraocular surgery Choroidal hemorrhage Chronic severe uveitis Concomitant severe eye disease Extremely shallow anterior chamber Medically uncontrolled glaucoma Microphthalmos Non-age-related cataract Proliferative diabetic retinopathy (severe) Severe corneal dystrophy Severe optic nerve atrophy Irregular corneal astigmatism Amblyopia Macular disease During Surgery Excessive vitreous loss Non-circular capsulotomy/capsulorhexis The presence of radial tears known or suspected at the time of surgery Situations in which the integrity of the circular capsulotomy/ capsulorhexis cannot be confirmed by direct visualization Cataract extraction by techniques other than phacoemulsification or liquefaction Capsular rupture Significant anterior chamber hyphema Uncontrollable positive intraocular pressure Zonular damage 24. Potential complications generally associated with cataract surgery include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information About Vision at Johnson & Johnson Johnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients’ eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at clearvisionforyou.com, follow @JNJVision on X, Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://www.jnjmedtech.com/en-US/. Follow us at @JNJMedTech on LinkedIn. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to TECNIS PureSee IOL. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. ©Johnson & Johnson and its affiliates 2026. All rights reserved. Footnotes: *TECNIS PureSee IOL achieved a 1.5-line difference in mean monocular distance-corrected near VA at 6 months compared to TECNIS 1-Piece. **In clinical evaluation, TECNIS PureSee IOL demonstrated contrast sensitivity comparable to an aspheric monofocal intraocular lens, with no clinically meaningful differences (≤0.3 log units) versus aspheric monofocal controls across pupil sizes, while maintaining distance visual acuity and low levels of visual symptoms. ^Daniel Chang, MD, is a paid consultant of Johnson & Johnson World Health Organization (WHO), 2022. Blindness and vision impairment. Available at: https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment. Centers for Disease Control and Prevention (2024) Cataract Data. Available from: https://www.cdc.gov/vision-health/about-eye-disorders. TECNIS PureSee™ IOL, Model DEN00V, DFU US, Z312075E rev B. Launch to Date Implants. Data on File. DOF2023CT4043 Clinical Investigation. Patient Satisfaction Outcomes. July 18, 2023. Harvard Medical School (2020) Considering Cataract Surgery? What You Should Know. Harvard Health Publishing REF2022OTH4464. American Academy of Ophthalmology. What Is Presbyopia? https://www.aao.org/eye-health/diseases/what-is-presbyopia Vision Loss Expert Group of the Global Burden of Disease Study and GBD 2019 Blindness and Vision Impairment Collaborators, 2024. Global estimates on the number of people blind or visually impaired by uncorrected refractive error: a meta-analysis from 2000 to 2020. Eye, 38, pp.2083–2101. https://doi.org/10.1038/s41433-024-03106-0 2026PP10682 View source version on businesswire.com: https://www.businesswire.com/news/home/20260611210092/en/ Media contact:
Maggie Lorenz
J&J | Communications

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapiesJune 11, 2026 2:03 AM
PR Newswire (US) Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as early as Week 1c More patients treated with IMAAVY experienced improvement in fatigued and corticosteroid dose reductionse IMAAVY is designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm autoimmune hemolytic anemia while preserving immune function Pivotal results will be presented at EHA 2026 STOCKHOLM, June 11, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today is presenting the first comprehensive results from the Phase 2/3 ENERGY study showing that IMAAVY® (nipocalimab-aahu) produced a statistically significant durable hemoglobin (Hgb) responseb with rapid onset of effect in patients with warm autoimmune hemolytic anemia (wAIHA)e in the 30 mg/kg treatment group,a compared with those who received placebo. The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks. Overall, patients treated with this dose of IMAAVY showed a mean Hgb improvement of at least 1g/dL as early as Week 1.1,c  To be presented at the European Hematology Association (EHA) 2026 Congress, these results mark an important step forward for people living with wAIHA, a rare, life-threatening condition for which patients currently have no U.S. Food and Drug Administration (FDA)-approved treatment options."These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells in people living with warm autoimmune hemolytic anemia," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy.g "Achieving hemoglobin improvements this quickly and at this scale is important in clinical practice, as it could help improve the debilitating fatigue that people living with warm autoimmune hemolytic anemia experience."Key findings from the Phase 2/3 ENERGY study
The ENERGY study compared IMAAVY to placebo in achieving the primary endpoint of durable Hgb improvement, which was defined as achieving the following stringent criteria1: An increase from baseline in Hgb ≥2 g/dL Hgb concentration ≥10 g/dL For at least three visits (≥28 days, where criteria was met, starting by Week 16)Without the need for rescue therapy or changes to background medications for wAIHAIn the 30 mg/kg treatment group, a mean increase of 1 g/dL in Hgb was observed at Week 1, compared to no change in the placebo group.c In wAIHA, treatment also aims to maintain Hgb ≥10 g/dL and achieve a ≥2 g/dL increase from baseline and nearly two-thirds of patients achieved both of these targets by Week 24.IMAAVY was also associated with improvements in fatigued and reduction in steroid usef, two key secondary endpoints. Changes in patient-reported fatigue were observed as early as Week 2 and sustained throughout the 24-week treatment period.dIn the study, IMAAVY demonstrated a safety profile consistent with the established safety profile of IMAAVY in the approved indication of generalized myasthenia gravis. The most common adverse reactions (≥10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea and fever.By targeting the pathogenic IgG autoantibodies that lead to red blood cell destruction in wAIHA, IMAAVY is designed to utilize a differentiated, immunoselective approach, preserving underlying key humoral immune functions in a condition where many patients currently can only rely on unapproved therapies, including corticosteroids and broad immunosuppressants.2"In the first large, placebo-controlled trial of its kind, IMAAVY delivered durable improvements in hemoglobin levels and showed no new safety signals, in a disease with no FDA-approved therapies," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "This immunoselective approach targets the underlying autoantibodies driving disease while preserving key immune functions, which is important for people living with this disease who frequently suffer with comorbid conditions."These data support the supplemental Biologics License Application (sBLA) for IMAAVY which has since been granted U.S. FDA Priority Review. Editor's Notes:a.  The dose submitted to the FDA for approval (30 mg/kg IV every four weeks). 
b.   Durable hemoglobin response, the primary endpoint of the Phase 2/3 ENERGY trial, is defined as hemoglobin concentration ≥10 g/dL and an increase from baseline in hemoglobin ≥2 g/dL for at least 28 days (where criteria was met starting by Week 16 of the double-blind period), without the need of rescue therapy. This endpoint was prespecified within the equal-weight hierarchical testing procedure; the resulting one-sided p-value was considered statistically significant in accordance with the predefined multiplicity control strategy.
c.   These data were not a part of the hierarchical testing procedure.
d.   Based on mean change from baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 24, a key secondary endpoint, with mean change of 3.51 points over placebo for 30 mg/kg IV treatment group (dose filed with the FDA). This endpoint was prespecified within the hierarchical testing procedure; the resulting one-sided p-value was considered nominal in accordance with the predefined multiplicity control strategy.
e.   IMAAVY is not approved for the treatment of warm autoimmune hemolytic anemia.
f.   Participants who achieved durable Hgb response were required to initiate corticosteroid (CS) dose tapering. Doses were reduced by 10% of the baseline CS dose every two weeks, provided Hgb levels did not decline by ≥1 g/dL. At Week 24, the mean percent reduction in CS dose was numerically higher in the nipocalimab 30 mg/kg treatment group (15% reduction from baseline dose) compared with placebo (4% reduction from baseline dose). This endpoint was prespecified within the hierarchical testing procedure.
g.   Dr. Bruno Fattizzo is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.ABOUT THE ENERGY TRIAL
ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA). 115 adults were randomized approximately 1:1:1 to receive nipocalimab at two different dose schedules or placebo. Following completion of 24 weeks of double-blind treatment, patients could enter an open-label extension period to receive nipocalimab for 144 weeks with a follow-up period of 6 weeks after last assessment.3ABOUT WARM AUTOIMMUNE HEMOLYTIC ANEMIA (wAIHA)
Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia.4 Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition.4,5 This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50.5,6 Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection.7There are no Food and Drug Administration (FDA)-approved drugs indicated for wAIHA, and treatment typically consists of unapproved corticosteroids, broad immunosuppressants, and B-cell directed therapies.4 With an unmet need for treatment in wAIHA, novel therapies like nipocalimab are being developed to potentially address this need.7ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.8Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus. 3,9,10,11,12,13,14,15,16,17The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including: EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, generalized myasthenia gravis (gMG) in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026The legal manufacturer for IMAAVY is Janssen Biotech, Inc.WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.It is not known if IMAAVY is safe and effective in children under 12 years of age.IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMAAVY?IMAAVY is a prescription medicine that may cause serious side effects, including:Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms: feverchillsshiveringcough sore throatfever blistersburning when you urinate Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or throatdifficulty swallowing or breathing itchy rash (hives)chest pain or tightnessInfusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion: headacherashnauseafatigue dizzinesschillsflu-like symptomsredness of skinDo not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis.Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:ever had an allergic reaction to IMAAVY.have or had any recent infections or symptoms of infection.have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.Follow us at @JNJInnovMed. Janssen Biotech, Inc. is a Johnson & Johnson company. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.REFERENCES1 Fattizzo B, Murakhovskaya I, Ueda.Y, Schlichting D, Sweet K, Zelasky M, Craig J, Liva S, Leu J, Ling L, Pease S, Anakor A, Shu C, Nipocalimab for warm autoimmune hemolytic anemia: results from the Phase 2/3 randomized, double-blind ENERGY study, Presented at EHA 2026 Congress, Available at https://library.ehaweb.org/eha/2026/eha-2026/4206854/bruno.fattizzo.nipocalimab.for.warm.autoimmune.hemolytic.anemia.results.from.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3DS300
2 Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1).?https://doi.org/10.1080/19420862.2025.2461191
3 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: June 2026.
4 National Organization for Rare Disorders, Warm autoimmune Hemolytic Anemia. Available at: https://rarediseases.org/rare-diseases/warm-autoimmune-hemolytic-anemia/. Last accessed: June 2026.
5 Tranekær S, Hansen DL, Frederiksen H. Epidemiology of Secondary Warm Autoimmune Haemolytic Anaemia-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 17;10(6):1244. doi: 10.3390/jcm10061244. PMID: 33802848; PMCID: PMC8002719.
6 Cherif, H, Cai, Q, Crivera, C, Leon, A, Rahman, I, Leval, A, Noel, W and Kjellander, C. (2024), Overall Survival and Treatment Patterns Among Patients With Warm Autoimmune Hemolytic Anemia in Sweden: A Nationwide Population-based Study. Eur J Haematol.?https://doi.org/10.1111/ejh.14311.
7 Fattizzo B, Barcellini W. New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfusion Medical Reviews, Vol. 36, Issue 4. October 2022 https://doi.org/10.1016/j.tmrv.2022.08.001.
8 IMAAVY® U.S. Prescribing Information.
9 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
10 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
11 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
12 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2026.
13 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
14 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
15 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026.
16 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2026.
17 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.Media contact:    Investor contact:Bridget Kimmel      Jess MargevichBKimmel@ITS.JNJ.com              Investor-relations@its.jnj.com  View original content to download multimedia:https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-demonstrates-durable-hemoglobin-response-and-rapid-onset-of-effect-in-pivotal-phase-23-study-in-warm-autoimmune-hemolytic-anemia-waiha-an-autoantibody-driven-disease-with-no-fda-approved-therapies-302797243.htmlSOURCE Johnson & Johnson Original: IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

Anyone seeing JNJ possibly buy any of the three major psychedelic companies? CMPS, DFTX or ATAI?

Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's diseaseJune 3, 2026 12:03 AM
PR Newswire (US) Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with Sjögren's disease while preserving immune function New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group Previously reported data from the Phase 2 study showed nipocalimab reduced Sjögren's disease activity and severity, with potential to address systemic manifestations and the most burdensome patient-reported symptoms including dryness, fatigue and painNipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA for the treatment of adults with moderate-to-severe Sjögren's disease. LONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new biomarker exploratory analyses from the Phase 2 DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren's disease (SjD)a showing that participants with elevated autoantibody and immunoglobulin G (IgG) levelsb, who are often those who experience more substantial disease burden, showed greater clinical response rates.1 These data will be presented in an oral session at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. A healthcare professional's perspective
"Sjögren's disease is a highly heterogeneous condition that has historically posed significant challenges for therapeutic development, leaving gaps in patient care," said R. Hal Scofield, M.D., the University of Oklahoma and Oklahoma Medical Research Foundation.c "These analyses provide important insight into the potential role of pathogenic immunoglobulin G autoantibodies in disease activity and help expand our understanding of the biological drivers of Sjögren's disease for certain patients. This research is critical for helping clinicians evaluate emerging evidence and the evolving treatment landscape in this chronic, underserved disease."New DAHLIAS Phase 2 clinical and biomarker findings 
Clinical improvements were observed across all patients, with the greatest responses observed in participants with elevated known disease-driving autoantibodies and IgG levels – factors associated with more severe SjD activity and outcomes.1 Previously reported positive Phase 2 study results demonstrated statistically significant improvement in ClinESSDAId scores with nipocalimab versus placebo.2 In the current analysis, patients in the autoantibody-high subgroupb treated with nipocalimab achieved higher response rates than observed in the overall participant population (62.5% versus 51.9%).1 These data support the continued investigation of nipocalimab as a potential immunoselective approach for systemic SjD management in the ongoing Phase 3 DAFFODIL study.Biomarker analyses reveal autoantibody and immune function insights
These findings further support the underlying mechanism of action of nipocalimab as a targeted, immunoselective approach designed to reduce pathogenic IgG autoantibodies associated with SjD disease activity while preserving broader immune function.3"The biomarker analyses are consistent with the hypothesized mechanism of nipocalimab in Sjögren's disease. These findings suggest greater response in the broad study population of adults with moderate-to-severe Sjögren's disease, plus a greater response observed among patients with elevated disease-driving autoantibodies and immunoglobulin G levels," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "The data also furthers our understanding of the role pathogenic IgG autoantibodies may play in this heterogenous disease as we continue to investigate nipocalimab in Sjögren's."Editor's Notes: a.Nipocalimab is not FDA approved for the treatment of SjD. b.Subgroup included patients with moderate-to-severe SjD who had the highest baseline levels of three disease-associated autoantibodies – anti-Ro60, anti-Ro52 and anti-La – measured in the study population.c.Dr. Scofield is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.d.ClinESSDAI is an endpoint specific to SjD and is a composite scale that assesses organ disease activity across 11 organ system domains [cutaneous, pulmonary, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), hematological, glandular, constitutional, lymphadenopathy and lymphoma; a higher score indicates greater symptom severity.ABOUT DAHLIAS 
DAHLIAS (NCT04968912) is a Phase 2 multicenter, randomized, placebo-controlled double-blind, dose-ranging study to evaluate the effects of nipocalimab in participants with moderately-to-severely active primary Sjögren's disease (SjD) who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies. 163 adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30. The primary endpoint was change in baseline in the ClinESSDAI (Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index) Score at Week 24. 4ABOUT SJÖGREN'S DISEASE 
Sjögren's disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.5 It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.6 SjD is characterized by autoantibody production, chronic inflammation and lymphocytic infiltration of exocrine glands.7 Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.8 More than 50% of SjD patients have a moderate-to-severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus (SLE).9,10,11 It is usually associated with impaired quality of life, and in up to approximately half of patients, a loss of functional capacity that can result in an inability to work due to a disability.10,11,12ABOUT NIPOCALIMAB 
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity and block neonatal Fc receptor (FcRn), reducing circulating immunoglobulin (IgG) antibodies that drive disease while also preserving key immune functions.13,14 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases andMaternal Fetal diseases mediated by maternal alloantibodies in which blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.4,15,16,17,18,19,20,21,22The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:??? EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, generalized myasthenia gravis (gMG) in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025 and systemic lupus erythematosus (SLE) in January 2026 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026ABOUT JOHNSON & JOHNSON 
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.?? Learn more at?https://www.jnj.com/?or at?www.innovativemedicine.jnj.com. Follow us at?@JNJInnovMed.?? Janssen Biotech, Inc. is a Johnson & Johnson company.  Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of?Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in?Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in?Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from?Johnson & Johnson.?Johnson & Johnson?does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Scofield, H et al. Biomarker-Driven Insights to Clinical Response in DAHLIAS: A Nipocalimab Trial for Sjogren's Disease. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. Oral Presentation #OP0131
2 Noaiseh, G et al., Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. The Lancet. Oct 2025; Nov 22;406(10518):2435-2448.
3 Seth NP, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025 Dec;17(1):2461191.
4 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
5 Huang H, et al. Mortality in patients with primary Sjögren's syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179
6 Beydon, M., et al. Epidemiology of Sjögren syndrome. Nat Rev Rheumatol. 2024 Mar;20(3):158-169. doi: 10.1038/s41584-023-01057-6.
7 Meudec L, Nocturne G, Mariette X. Update on the Aetiopathogenesis of Sjögren Disease: From Interferon Signaling to Epithelial Dysfunction. J Clin Med. 2026 Mar 4;15(5):1945. doi: 10.3390/jcm15051945
8 Mayo Clinic. Sjogren's syndrome. Available at: https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216. Last accessed: June 2026.
9 Lim ZFS, et al. Regulatory T cell therapy for Sjögren's disease: From pathogenesis to targeted treatment. J Transl Autoimmun. 2025 Aug 26;11:100311. doi: 10.1016/j.jtauto.2025.100311.
10 Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/
11 Hackett KL, et al. Impaired functional status in primary Sjögren's syndrome. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1760-4.
12 Meijer JM, et al. Health-related quality of life, employment and disability in patients with Sjogren's syndrome. Rheumatology (Oxford). 2009 Sep;48(9):1077-82. doi: 10.1093/rheumatology/kep141. Epub 2009 Jun 24. PMID: 19553376.
13 Ling LE., et al. M281, an anti–fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first–in–human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
14 National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). https://www.niams.nih.gov/health-topics/lupus. Last accessed: June 2026.
15 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
16 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
17 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
18 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: June 2026.
19 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
20 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026.
21 ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: June 2026.
22 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.Media contact: Investor contact:Bridget KimmelJess MargevichBKimmel@ITS.JNJ.com Investor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-presents-new-data-further-reinforcing-the-role-of-nipocalimab-in-lowering-the-autoantibodies-driving-sjogrens-disease-302789435.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's disease

Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 studyJune 3, 2026 12:04 AM
PR Newswire (US) Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune functionResults demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg groupaThe ongoing Phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damageLONDON, June 3, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SLE Responder Index 4 (SRI-4)b and continued to demonstrate sustained reduction in disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE)a through 52 weeks in the Phase 2 JASMINE study as measured by both SRI-4b and Lupus Low Disease Activity State (LLDAS).c In addition, the study results showed greater response versus placebo plus background medicationd in participants who tested positive for lupus-associated autoantibodies, which represents the vast majority (~80%) of people living with SLE.e,1 These findings will be featured in a late-breaking presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and are among the 38 abstracts the Company is presenting across its Rheumatology portfolio.  Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin (IgG) autoantibodies and immune complexes associated with inflammation in SLE.2,3 By reducing circulating IgG, including autoantibodies, nipocalimab is designed to target the underlying cause of disease while preserving critical immune functions.4 JASMINE is the first clinical study to demonstrate efficacy of FcRn blockade in SLE and provides clinical, biomarker and pharmacodynamic evidence supporting the continued investigation of nipocalimab as a potential treatment option for this disease.5A healthcare professional's perspective
"The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus," said Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell.f "These 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage."JASMINE Phase 2 clinical findings
The Phase 2 JASMINE study is the first proof-of-concept for a FcRn-blocker in SLE and demonstrates the potential of nipocalimab to reduce disease activity, with greater responses observed in autoantibody-positive patients.1,5The study met its primary endpoint at Week 24, with a greater proportion of patients receiving nipocalimab 15 mg/kg plus background medication achieving an SRI-4b response compared with placebo plus background medication (53.5% vs 46.7%). In a predefined autoantibody-positive patient populatione, greater SRI-4 response rates were observed (58.2% vs. 36.1%) and greater achievement of LLDAS (38.9% vs. 18.0%) compared with placebo plus background medication at Week 52.At Week 52, a key secondary endpoint, 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4b response, compared with 39.7% for placebo plus background medication.More patients receiving nipocalimab 15 mg/kg also achieved LLDASc, a key exploratory endpoint that enables a treat-to-targetg approach, compared with placebo plus background medication (37.5% vs. 20.5%) at Week 52.Nipocalimab had a safety profile consistent with previous studies of nipocalimab and no new safety signals were identified. The most common adverse reactions in patients with SLE treated with nipocalimab (≥10%) were nasopharyngitis, headache, urinary tract infection and nausea.5"The JASMINE results provide important new insights into the potential of nipocalimab for adults with moderate-to-severe systemic lupus erythematosus as we continue advancing this program," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "We are especially encouraged by the responses observed in autoantibody-positive study participants. These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus." Nipocalimab received Fast Track Designation in SLE by the U.S. Food and Drug Administration (FDA) earlier this year. The ongoing Phase 3 GARDENIA study is currently recruiting.Editor's Notes: a. Nipocalimab is not FDA-approved for SLE. b. The SRI-4 is a composite measure used to assess treatment response in patients with SLE during clinical studies. It comprises criteria from three different internationally validated indices, SELENA-SLE Disease Activity Index (SELENA-SLEDAI), Physician Global Assessment (PGA) and the British Isles Lupus Assessment Group (BILAG) 2004.c. LLDAS definition: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. d. Protocol-permitted background medications include oral corticosteroids, antimalarials and no more than two of the following immunomodulatory drugs: azathioprine, mycophenolate mofetil, mycophenolic acid, oral methotrexate.e. The autoantibody-positive population was defined as participants who met ≥1 of the following during screening: (1) positive anti-double-stranded DNA (anti-dsDNA), (2) positive anti-Smith, (3) positive antinuclear antibodies (ANA) and positive for anti-Ro, anti-RNP or had a history of anti-dsDNA.f. Dr. Richard Furie has provided consulting, advisory and speaking services to?Johnson & Johnson. He has not been paid for any media work.g. Treat-to-target in SLE is a therapeutic strategy in which treatment is guided by regular assessment of disease activity and adjusted to achieve a predefined target – primarily remission, or low disease activity if remission is not attainable – to improve long-term outcomes and prevent organ damage.6ABOUT JASMINE
JASMINE (NCT04882878) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate nipocalimab in 228 adult participants with active systemic lupus erythematosus (SLE). Adults aged 18-65 years with moderate-to-severe SLE, defined by established measures of disease activity, who were positive for antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA), and/or anti-Smith antibodies, and had not responded to at least one standard-of-care treatment were enrolled. Participants were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 52, in addition to protocol-permitted background medications. The primary endpoint was the SLE Responder Index-4 (SRI-4) composite response at Week 24. Pharmacodynamic effects and safety, including adverse events, were assessed through Week 58.5ABOUT SYSTEMIC LUPUS ERYTHEMATOSUS
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that occurs when the body's immune system mistakenly attacks its own healthy tissues.7,8 This can lead to inflammation and damage in many parts of the body, including the skin, joints, heart, lungs, kidneys and brain.3 SLE affects nine times more women than men, often striking initially between the ages of 15-44.9 In addition to systemic organ damage, other complications of SLE can include end-stage renal failure, scarring cutaneous lesions, neurological damage and various forms of cardiovascular disease.3 People living with SLE often face reduced health-related quality of life, due to severe fatigue, mood disturbances, joint pain, swelling and rashes, including the hallmark butterfly-shaped facial rash, as well as complications of long-term glucocorticoid use.10 Severe fatigue is the most widely reported and debilitating symptom of SLE, affecting up to 80% of people with SLE.11 SLE is the most common form of lupus, affecting 3 to 5 million people worldwide, approximately 70% of lupus cases.12,13 It is estimated that 450,000 people in the United States are affected by SLE.14ABOUT NIPOCALIMAB 
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity, and block neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving key immune functions.2,3 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic disease, Rare Autoantibody diseases and Maternal Fetal diseases mediated by maternal alloantibodies in which blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus. 5,15,16,17,18,19,20,21,22,23The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:?EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025 U.S. FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, generalized myasthenia gravis (gMG) in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025 and systemic lupus erythematosus (SLE) in January 2026 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 and in wAIHA in Q2 2026 ABOUT JOHNSON & JOHNSON 
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.Learn more at?https://www.jnj.com/?or at?www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.?Janssen Biotech, Inc. is a?Johnson & Johnson?company.? Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Richard A Furie, Ronald van Vollenhoven, Rafal Wojciechowski, Eric Morand, Guillermo J. Pons-Estel, George A Karpouzas, Bart van Hartingsveldt, Robert W Hoffman, Terence Rooney, Sheng Gao, Robert Gordon, Kim Hung Lo, Jocelyn H. Leu, Federico Zazzetti, Stanley J. Marciniak, Steven Leonardo, Keying Ma, Kathy Sivils, Leonard Dragone, Loqmane Seridi, Linda Okonkwo, Erika Noss, Fang Liu-Walsh, Michelle Petri. Nipocalimab in SLE: First-in-class efficacy and safety results demonstrating proof of concept for FcRn blockade from the Phase 2 JASMINE-SLE study. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
2 Ling LE., et al. M281, an anti–fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first–in–human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
3 National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). https://www.niams.nih.gov/health-topics/lupus. Last accessed: April 2026.
4 Cossu M et al. A randomized, open-label study on the effect of nipocalimab vaccine response in healthy participants. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
5 ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: June 2026
6 Bracalenti M, Iaccarino L, Doria A. Remission and low disease activity in systemic lupus erythematosus. Rare Dis Orphan Drugs J. 2025;4:28. https://dx.doi.org/10.20517/rdodj.2025.10
7 Lupus Foundation of America. Understanding Lupus https://www.lupus.org/understanding-lupus. Last accessed: June 2026.
8 Kawka L, et al. Fatigue in Systemic Lupus Erythematosus: An Update on Its Impact, Determinants and Therapeutic Management. J Clin Med. 2021 Sep 3;10(17):3996. doi: 10.3390/jcm10173996. PMID: 34501444; PMCID: PMC8432566.
9 Guéry JC. Why Is Systemic Lupus Erythematosus More Common in Women? Joint Bone Spine. 2019 May;86(3):297-299. doi: 10.1016/j.jbspin.2018.12.004. Epub 2018 Dec 22. PMID: 30584922.
10 Centers for Disease Control and Prevention. (2024). Symptoms of lupus. https://www.cdc.gov/lupus/signs-symptoms/. Last accessed: June 2026.
11 Lupus Foundation of America. Understanding the Invisible Impact of Lupus. Available at: https://www.lupus.org/resources/understanding-the-invisible-impact-of-lupus. Last accessed: June 2026.
12 Tian, J., Zhang, D., Yao, X., Huang, Y., & Lu, Q. (2023). Global epidemiology of systemic lupus erythematosus: A comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases, 82(3), 351–356. https://doi.org/10.1136/ard-2022-223035
13 Lupus Foundation of America. Lupus facts and statistics. https://www.lupus.org/resources/lupus-facts-and-statistics. Last accessed: June 2026.
14 Wang, Y., Hester, L. L., Lofland, J., Rose, S., Karyekar, C.S., Kern, D.M., Blacketer, M., Davis, K., & Sheilds-Tuttle, K. (2022). Update on the prevalence of diagnosed systemic lupus erythematosus (SLE) by major health insurance types in the US in 2016. BMC Research Notes, 15, 5. https://doi.org/10.1186/s13104-021-05877-1
15 ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: June 2026.
16 ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: June 2026.
17 ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: June 2026.
18 ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: June 2026.
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20 ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: June 2026.
21 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
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23 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.Media contact:
Bridget KimmelBKimmel@ITS.JNJ.com  Investor contact:
Jess MargevichInvestor-relations@its.jnj.com    View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-late-breaking-results-show-nipocalimab-significantly-reduced-systemic-lupus-erythematosus-sle-disease-activity-in-a-phase-2-study-302789438.htmlSOURCE Johnson & Johnson Original: Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limitedMay 31, 2026 8:29 AM
PR Newswire (US) More than one-third of responders with previously treated disease achieved complete responses, with median duration of response not yet reached, as reported in new Journal of Clinical Oncology publication RYBREVANT FASPRO™, an EGFR- and MET-targeting dual inhibitor, is the first and only subcutaneous therapy being evaluated in this setting Johnson & Johnson submitted a supplemental Biologics License Application to U.S. FDA seeking approval for this indication CHICAGO, May 31, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy. Confirmed overall response rate was 42 percent, with more than one-third of responders achieving complete responses. Median duration of response was not yet reached, with a median follow up of 11.8 months.1 These data were featured in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #6008) and simultaneously published in the Journal of Clinical Oncology (JCO).2 Together, with additional data presented in lung and colorectal cancers, these findings further demonstrate the expanding role of the amivantamab portfolio across tumor types. A supplemental Biologics License Application (sBLA) seeking approval for subcutaneous amivantamab in head and neck cancer has been submitted to the U.S. Food and Drug Administration (FDA), following Breakthrough Therapy Designation.High unmet need remains in advanced head and neck cancerHead and neck squamous cell carcinoma is an aggressive disease that can significantly affect quality of life, with symptoms such as pain and difficulty swallowing that can make it hard to eat, speak and maintain proper nutrition.3,4 Certain forms of head and neck cancer, including tumors of the mouth, voice box and parts of the throat, are among the most difficult to treat, and are associated with poorer outcomes and persistent unmet need.5 Across head and neck cancers, up to half of patients will experience recurrence or metastatic disease, even when treated at an early stage.3 Once the disease becomes recurrent or metastatic, five-year survival is approximately 15 percent.6 For patients who receive additional treatment, current options provide limited benefit with response rates rarely exceeding 24 percent, and few patients achieve a complete response.7,8Dual-targeting mechanism helps address tumor growth and resistanceSubcutaneous amivantamab is designed to dual target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), two pathways associated with tumor growth and resistance, while engaging the immune system.9"Patients with recurrent or metastatic head and neck cancer who have already been treated with immunotherapy and chemotherapy face very poor outcomes," said Barbara Burtness, M.D.,* medical oncologist and professor of medicine at Yale Cancer Center in New Haven, Connecticut. "The high response seen with subcutaneous amivantamab on its own, including more than one-third of responders achieving complete responses, and the durability of those responses, suggests it has the potential to meaningfully improve expectations for these patients."Detailed OrigAMI-4 study resultsCohort 1 of the OrigAMI-4 study evaluated subcutaneous amivantamab monotherapy in 102 patients with recurrent or metastatic head and neck cancer who had previously received immunotherapy and platinum-based chemotherapy, excluding patients with human papillomavirus (HPV)-positive oropharyngeal cancer. Patients received treatment every three weeks following an initial loading dose. The primary endpoint was overall response rate, as assessed by local investigators per protocol. Responses were confirmed via blinded independent central review (BICR).1 Based on BICR, confirmed overall response rate was 42 percent (95 percent confidence interval [CI], 32-52), including complete responses in more than one-third of responders (15 percent) and a 27 percent partial response rate. Clinical benefit rate was 63 percent (95 percent CI, 53-72), and median time to first response was 6.6 weeks (range, 5.6-36.9). At the time of analysis (median follow-up of 11.8 months), median duration of response had not yet been reached among confirmed responders, demonstrating notable durability. Median progression-free survival and overall survival were 6.8 months and 12.5 months, respectively.1The safety profile of subcutaneous amivantamab monotherapy was consistent with prior reports, with no new safety signals identified. Most treatment-related adverse events were Grade 1 or 2 (mild to moderate) and associated with EGFR or MET inhibition. The most common on-target adverse events included hypoalbuminemia (50 percent), rash (37 percent), paronychia (34 percent) and dermatitis acneiform (34 percent). Administration-related reactions occurred in 15 percent of patients, with no Grade 3 or higher events reported. Treatment-related discontinuations remained low at eight percent.1"Progress has been limited for patients with recurrent and metastatic head and neck cancer, highlighting the need for differentiated approaches that can address the disease more comprehensively," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "Subcutaneous amivantamab is the only therapy of its kind being studied in this disease, targeting both EGFR and MET while engaging the immune system. The encouraging responses we're seeing in OrigAMI-4, along with a well-established and manageable safety profile, underscore the potential of this approach and move us closer to delivering a fast, convenient treatment option."Ongoing study of RYBREVANT FASPRO™ in head and neck cancerA trial-in-progress update from the Phase 3 OrigAMI-5 study (NCT07276399) was also shared at ASCO 2026 (Abstract #583a). The study is evaluating subcutaneous amivantamab in combination with carboplatin and pembrolizumab as a first-line treatment for patients with recurrent or metastatic head and neck cancer, with the goal of improving outcomes in the first-line setting.10RYBREVANT FASPRO™ is already approved in more than 40 countries, including the United States, Europe, Japan, and other markets, as a subcutaneous treatment for patients with EGFR-mutated non-small cell lung cancer.11About the OrigAMI-4 StudyOrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes five cohorts exploring RYBREVANT FASPRO™ across different treatment settings and regimens.Cohort 1 evaluated RYBREVANT FASPRO™ as monotherapy in patients with R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Patients with HPV-positive oropharyngeal squamous cell carcinoma were excluded, as well as those with prior anti-EGFR therapy.RYBREVANT FASPRO™ was administered on a weekly schedule during the initial treatment period followed by dosing every three weeks (Q3W), with weight-based dosing adjustments. The primary endpoint across cohorts is overall response rate (ORR), as assessed by investigators, using RECIST v1.1.†12About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinoma (HNSCC) is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity, and salivary glands.13 It represents approximately 4.5 percent of all cancers worldwide and is the seventh most common cancer globally.13 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).13 Approximately 80 percent of recurrent or metastatic HNSCC are not driven by HPV, and are typically associated with poorer prognosis and reduced response to treatment.13, 14 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced, recurrent or metastatic disease.15,16About RYBREVANT FASPRO™ and RYBREVANT®RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly‡ or bi-weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.RYBREVANT® (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO™ across multiple markets. RYBREVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)§17 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information. || The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases. || Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.The legal manufacturer for RYBREVANT FASPRO™ and RYBREVANT® is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.comINDICATIONSRYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and RYBREVANT® (amivantamab-vmjw) are indicated:in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO™ AND RYBREVANT® 10,18CONTRAINDICATIONSRYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™ RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity.Infusion-Related Reactions with RYBREVANT®RYBREVANT® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT® in 2.8% of patients.RYBREVANT® as a Single AgentIn CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT® in 1.3% of patients.Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®.Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO™ and RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with LAZCLUZE®In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis.RYBREVANT® as a Single AgentIn CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis.Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE®RYBREVANT FASPRO™ and RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777).Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT®. Treatment can continue with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE® Prescribing Information for recommended LAZCLUZE® dosage modification.Dermatologic Adverse ReactionsRYBREVANT FASPRO™ and RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients.RYBREVANT® with LAZCLUZE®In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed.RYBREVANT® as a Single AgentIn CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severity.HepatotoxicityLAZCLUZE® in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).RYBREVANT® with LAZCLUZE®In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE®, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE® was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE® and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE® and amivantamab based on severity.Ocular ToxicityRYBREVANT FASPRO™ and RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.RYBREVANT® with LAZCLUZE®In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.RYBREVANT® as a Single AgentIn CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® and continue LAZCLUZE® based on severity.Embryo-Fetal ToxicityBased on animal models, RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®.ADVERSE REACTIONSRYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).RYBREVANT® with Carboplatin and PemetrexedIn MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT® as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE® DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE®.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.*Barbara Burtness, M.D. has served as a consultant to Johnson & Johnson; she has not been paid for any media work. † RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.‡ Once monthly after weekly injections from weeks 1-4.§ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.|| See the NCCN Guidelines for detailed recommendations, including other treatment options. The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.1 Burtness B, et al. Amivantamab in recurrent/metastatic head & neck squamous cell cancer after disease progression on immune checkpoint inhibitor and chemotherapy. Pivotal results from the phase 1b/2 OrigAMI-4 study. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31, 2026; Chicago, Illinois.
2 Burtness B, et al. Amivantamab in recurrent/metastatic HNSCC after checkpoint inhibitor and chemotherapy: pivotal results from the phase 1b/2 OrigAMI-4 study. Epub May 31, 2026. doi:10.1200/JCO-26-01042.
3 Zebralla V, Wichmann G, Pirlich M, et al. Dysphagia, voice problems, and pain in head and neck cancer patients. Eur Arch Otorhinolaryngol. 2021;278(10):3985-3994. doi:10.1007/s00405-020-06584-6
4 Nissi L, et al. Recurrence of head and neck squamous cell carcinoma in relation to high-risk treatment volume. Clin Transl Radiat Oncol. 2021;27:139-146. doi:10.1016/j.ctro.2021.01.013
5 Dunn LA, Ho AL, Pfister DG. Head and neck cancer: a review. JAMA. 2026;335(6):531-541. doi:10.1001/jama.2025.21733
6 Soulieres D, et al. LBA48 BURAN: A phase III study of buparlisib (BUP) plus paclitaxel (PAC) in patients with PD-1(PD-L1)-pretreated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Ann Oncol. 2025;36:S1707.
7 Fayette J, et al. INTERLINK-1: A Phase III, randomized, placebo-controlled study of monalizumab plus cetuximab in recurrent/metastatic head and neck squamous cell carcinoma. Clin Cancer Res. 2025;31(13):2617-2627. doi:10.1158/1078-0432.CCR-25-0073
8 Große-Thie C, Maletzki C, Junghanss C, Schmidt K. Long-term survivor of metastatic squamous-cell head and neck carcinoma with occult primary after cetuximab-based chemotherapy: A case report. World J Clin Cases. 2021;9(24):7092-7098. doi:10.12998/wjcc.v9.i24.7092
9 Harrington KJ, Rosenberg AJ, Yang MH, et al. Subcutaneous amivantamab in recurrent/metastatic head and neck squamous cell cancer after disease progression on checkpoint inhibitor and chemotherapy: Preliminary results from the phase 1b/2 OrigAMI-4 study. Oral Oncol. 2025;171:107791. doi:10.1016/j.oraloncology.2025.107791
10 Haddad R, et al. OrigAMI-5: A randomized, phase 3 study of amivantamab plus pembrolizumab and carboplatin vs standard of care pembrolizumab plus platinum and 5-fluorouracil as first-line treatment in recurrent/metastatic head and neck cancer. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30, 2026; Chicago, Illinois.
11 RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
12 ClinicalTrials.gov. A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-4). https://clinicaltrials.gov/study/NCT06385080?term=OrigAMI-4&limit=10&rank=1. Accessed May 2026.
13 Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. Epidemiology, Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Med Sci (Basel). 2023;11(2):42. Published 2023 Jun 13. doi:10.3390/medsci11020042
14 Ghiani L, Chiocca S. High Risk-Human Papillomavirus in HNSCC: Present and Future Challenges for Epigenetic Therapies. International Journal of Molecular Sciences. 2022;23(7):3483. https://doi.org/10.3390/ijms23073483
15 Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. New England Journal of Medicine. 2016;375(19):1856-1867. doi:10.1056/NEJMoa1602252
16 Wise-Draper TM, Bahig H, Tonneau M, Karivedu V, Burtness B. Current Therapy for Metastatic Head and Neck Cancer: Evidence, Opportunities, and Challenges. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_350442
17 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed May 2026.
18 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.comInvestor contact:
Jess Margevich 
investor-relations@its.jnj.com 


U.S. Medical Inquiries: 
+1 800 526-7736  View original content to download multimedia:https://www.prnewswire.com/news-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-pivotal-data-show-strong-and-durable-responses-in-advanced-head-and-neck-cancer-where-options-remain-limited-302786430.htmlSOURCE Johnson & Johnson Original: RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited

Johnson & Johnson's Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigmMay 31, 2026 8:27 AM
PR Newswire (US) Patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20% reduction in the risk of developing metastasis or death Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of MedicineCHICAGO, May 31, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of apalutamide plus hormone therapy (androgen deprivation therapy, ADT), given for six months before and after prostate cancer surgery, significantly improved key short- and long-term clinical outcomes for patients with high-risk localized or locally advanced disease. The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease). The combination also reduced the risk of developing metastasis or death by 20 percent and extended the time before patients required subsequent therapy to more than six years. These findings will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Oral Abstract #LBA1) and published simultaneously in The New England Journal of Medicine.1,2 The unmet need with standard treatments for patients with high-risk localized prostate cancerSurgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localized or locally advanced disease, alongside radiation therapy.3,4 Yet nearly half of patients who undergo curative-intent surgery will see their cancer return, requiring additional treatment and moving beyond the point where cure is possible.5,6,7 Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.8 Apalutamide blocks androgen hormones from binding to their receptor, which can help slow prostate cancer progression. It is currently approved for use in advanced prostate cancer, including cases where the disease has spread (metastatic castration-sensitive) or is no longer responding to certain hormone therapies (non-metastatic castration-resistant prostate cancer).9Expert perspectives on the perioperative use of ERLEADA® plus hormone therapy six months before and after prostate cancer surgery"Reducing the risk of prostate cancer recurrence and death with improved initial treatment regimens has been a longstanding unmet need for patients with localized high-risk prostate cancer," said Mary-Ellen Taplin,* M.D., FASCO, medical oncologist at Dana-Farber Cancer Institute and Harvard Medical School, and principal investigator. "The PROTEUS trial demonstrates that adding preoperative apalutamide to androgen deprivation therapy and surgery reduced the risk of metastases or death by 20 percent. This result is most impactful as it may reduce the need for subsequent therapies and related side effects, while also increasing potential cure rates. This approach, which combines systemic therapy with surgery, is already standard in other aggressive cancers and now has proven benefit in patients with this disease.""For decades, surgery has been the standard approach for many patients with high-risk localized or locally advanced prostate cancer, but these data suggest it may not be enough on its own," said Adam Kibel,† M.D., urologic surgeon and chair of the Department of Urology at Mass General Brigham. "Earlier integration of apalutamide has the potential to reshape how prostate cancer is treated by building on curative-intent surgical treatment and improving outcomes for these patients."Detailed PROTEUS study resultsPROTEUS is a Phase 3 study evaluating apalutamide, an androgen receptor pathway inhibitor, combined with hormone therapy before and after surgery in patients with newly diagnosed high-risk localized or locally advanced prostate cancer (n=2109). The dual primary endpoints were the amount of cancer remaining at surgery (pathologic complete response/minimal residual disease, pCR/MRD) and how long patients lived without the cancer spreading (metastasis-free survival, MFS), both assessed by blinded independent central review.1At a median follow-up of 61.7 months, apalutamide plus hormone therapy met both primary endpoints. The rate of pCR/MRD was 8.9 percent with apalutamide plus hormone therapy versus 1.0 percent with hormone therapy alone (odds ratio [OR], 10.17; 95 percent confidence interval [CI], 5.27-19.64; p

RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancerMay 29, 2026 2:00 PM
PR Newswire (US) Median overall survival, a secondary endpoint, reached nearly 3.5 years with Johnson & Johnson's RYBREVANT® plus LAZCLUZE® in atypical EGFR-mutated diseaseConsistent responses observed across atypical EGFR mutation subgroups, including those historically associated with poorer outcomesASCO 2026 results reinforce the significance of RYBREVANT®-based regimens for patients across EGFR mutationsCHICAGO, May 29, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 1/1b CHRYSALIS-2 study evaluating intravenous RYBREVANT® (amivantamab-vmjw) in combination with LAZCLUZE® (lazertinib) in patients with advanced non-small cell lung cancer (NSCLC) with atypical epidermal growth factor receptor (EGFR) mutations. The analysis showed encouraging long-term outcomes with RYBREVANT® plus LAZCLUZE® in this difficult-to-treat population. Median overall survival, a secondary endpoint, was nearly 3.5 years.1 The primary endpoint of objective response rate was previously reported.2 These results add to the growing body of evidence demonstrating the potential of RYBREVANT® plus LAZCLUZE® to deliver durable survival outcomes across both common and atypical EGFR-mutated advanced NSCLC in the first-line setting. Data were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8501).1 Significant unmet need in patients with atypical EGFR-mutated NSCLCPatients with atypical EGFR-mutated NSCLC tend to have poorer outcomes than those with common EGFR mutations (exon 19 deletions and L858R substitutions), and effective first-line treatment options remain limited.3,4 These mutations represent approximately 10-20 percent of all EGFR-mutated cases.5 Median overall survival with current standard of care single-agent therapies remains under two years, highlighting a significant unmet need for treatments that can deliver more durable benefit in this setting.6,7 RYBREVANT® is designed to dual target EGFR and mesenchymal-epithelial transition (MET), while engaging the immune system.8,9,10,11 These complementary mechanisms play a central role in tumor growth and treatment resistance and may help address the underlying drivers of disease.Expert and company perspectives supporting the strength of RYBREVANT® plus LAZCLUZE®"For patients with non-small cell lung cancer harboring atypical EGFR-mutations, first-line treatment decisions are often clouded by uncertainty regarding the efficacy of currently available EGFR tyrosine kinase inhibitors," said Joel Neal,* M.D., Ph.D., principal investigator of the Phase 1/1b CHRYSALIS-2 study. "The responses we've seen in this trial suggest the potential for more durable disease control, and the overall survival data reinforce that picture. These long-term outcomes begin to change how we think about treatment options in managing this subtype of lung cancer." Neal is also a Professor of Medicine in the Division of Oncology at Stanford Medicine."Disease progression and molecular resistance remain critical barriers in EGFR-mutated non-small cell lung cancer," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "RYBREVANT-based combinations demonstrate the power of changing the biology by addressing multiple disease drivers from the start rather than relying on single-pathway strategies. With strong outcomes across all known EGFR mutations, this approach is raising the bar for what first-line treatment can achieve."Detailed CHRYSALIS-2 study resultsIn Cohort C of the CHRYSALIS-2 study, RYBREVANT® plus LAZCLUZE® was evaluated as a first-line treatment in patients with atypical EGFR-mutated advanced NSCLC, excluding EGFR exon 20 insertion mutations (n=49). The most common atypical EGFR mutations included G719X (55 percent), S768X (27 percent) and L861X (24 percent), with 35 percent of patients harboring multiple atypical mutations. The study previously reported an objective response rate of 57 percent (primary endpoint).1,2Median overall survival with RYBREVANT® plus LAZCLUZE® reached nearly 3.5 years (41.0 months; 95 percent confidence interval [CI], 27.7-not estimable) at a median follow-up of 31.3 months. Overall survival rates were 55 percent at three years and 46 percent at four years.1Consistent clinical activity was observed across atypical EGFR mutation subgroups, as well as across patient and disease characteristics such as central nervous system metastases and TP53 status. Patients were also able to remain on treatment long-term across mutation groups and baseline characteristics. Notably, 41 percent of patients remained on RYBREVANT® for two years or longer, further supporting the durable survival observed with this combination.1The safety profile of RYBREVANT® plus LAZCLUZE® was consistent with previous reports, with no new safety signals observed with longer follow-up. Most adverse events were Grade 1 or 2. The most common treatment-emergent adverse events occurring in more than 30 percent of patients included paronychia (78 percent), rash (65 percent), hypoalbuminemia (61 percent) and infusion-related reactions (61 percent).1RYBREVANT®-based regimens are approved for patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, including in the first-line setting.12 These results further define long-term outcomes with first-line RYBREVANT® plus LAZCLUZE® for patients with atypical EGFR mutations. Additional data being presented at ASCO 2026 in lung, head and neck, and colorectal cancers underscore the broader potential of RYBREVANT® across tumor types.About the CHRYSALIS-2 StudyCHRYSALIS-2 (NCT04077463) is an open-label Phase 1/1b study to evaluate the safety and pharmacokinetics of LAZCLUZE®, a third-generation EGFR-TKI, as monotherapy or in combinations with RYBREVANT®, a human bispecific EGFR and cMet antibody in participants with advanced NSCLC. The study enrolled 460 patients with advanced NSCLC.13Cohort C of the ongoing CHRYSALIS-2 study evaluates patients with atypical EGFR-mutated advanced NSCLC, excluding exon 20 insertion and classical EGFR mutations, who are treatment-naïve or have received up to two prior lines of therapy. Patients received intravenous RYBREVANT® in combination with LAZCLUZE® administered orally once daily.13About Non-Small Cell Lung Cancer Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.14,15 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.16 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.17 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.14,15,18,19,20,21 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.22 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.23,24 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.25 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.26About RYBREVANT®RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly† or bi-weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.RYBREVANT® (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO™ across multiple markets. RYBERVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 27 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ ||The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.The legal manufacturer for RYBREVANT® is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.About LAZCLUZE®In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE® (marketed as LECLAZA in South Korea). LAZCLUZE® is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of LAZCLUZE® from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.28The legal manufacturer for LAZCLUZE® is Janssen Biotech, Inc. and Yuhan Corporation.INDICATIONSRYBREVANT® (amivantamab-vmjw) is indicated:in combination with LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO™ AND RYBREVANT® 12,29CONTRAINDICATIONSRYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™ RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity.Infusion-Related Reactions with RYBREVANT®RYBREVANT® can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT® in 4.5% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT® in 2.8% of patients.RYBREVANT® as a Single AgentIn CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT® in 1.3% of patients.Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT® as recommended. Administer RYBREVANT® via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT® based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT®.Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO™ and RYBREVANT® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with LAZCLUZE®In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT® and LAZCLUZE® due to ILD/pneumonitis.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT® due to ILD/pneumonitis.RYBREVANT® as a Single AgentIn CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT® due to ILD/pneumonitis.Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE®RYBREVANT FASPRO™ and RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT®, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE®; 1% of patients had VTE leading to dose reductions of RYBREVANT®, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE®; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT®, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE®. The median time to onset of VTEs was 84 days (range: 6 to 777).Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT® and LAZCLUZE® at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT®. Treatment can continue with LAZCLUZE® at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE® Prescribing Information for recommended LAZCLUZE® dosage modification.Dermatologic Adverse ReactionsRYBREVANT FASPRO™ and RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients.RYBREVANT® with LAZCLUZE®In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT® and 30% for LAZCLUZE®, rash leading to dose reductions occurred in 23% of patients for RYBREVANT® and 19% for LAZCLUZE®, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT® and 1.7% for LAZCLUZE®.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT® and 3.1% discontinued pemetrexed.RYBREVANT® as a Single AgentIn CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® based on severityHepatotoxicityLAZCLUZE® in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).RYBREVANT® with LAZCLUZE®In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE®, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE® was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE® and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE® and amivantamab based on severity.Ocular ToxicityRYBREVANT FASPRO™ and RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.RYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.RYBREVANT® with LAZCLUZE®In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.RYBREVANT® with Carboplatin and PemetrexedBased on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.RYBREVANT® as a Single AgentIn CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT® and continue LAZCLUZE® based on severity.Embryo-Fetal ToxicityBased on animal models, RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT®. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT®, and for 3 weeks after the last dose of LAZCLUZE®.ADVERSE REACTIONSRYBREVANT FASPRO™ with LAZCLUZE®In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gammaglutamyl transferase (2%), and decreased hemoglobin (2%).Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).RYBREVANT® with LAZCLUZE®In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT®) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT®) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).RYBREVANT® with Carboplatin and PemetrexedIn MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.RYBREVANT® as a Single AgentIn CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.LAZCLUZE® DRUG INTERACTIONSAvoid concomitant use of LAZCLUZE® with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT® and LAZCLUZE®.cp-491009v2About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT®-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.###* Joel W. Neal, M.D., Ph.D., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.† Once monthly after weekly injections from weeks 1-4.‡ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.§ See the NCCN Guidelines for detailed recommendations, including other treatment options.|| The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.Source: Johnson & Johnson1 Neal JW, et al. Overall survival of first-line amivantamab plus lazertinib in atypical EGFR-mutated advanced NSCLC: Updated results from the CHRYSALIS-2 study. Presented at: 2026 ASCO Annual Meeting; 2026; Chicago, IL.
2 Tomasini P, Wang Y, Li Y, et al. Amivantamab Plus Lazertinib in Atypical EGFR-Mutated Advanced Non-Small Cell Lung Cancer: Results From CHRYSALIS-2. J Clin Oncol. 2026;44(1):54-65. doi:10.1200/JCO-24-02835
3 Kim EY, Cho EN, Park HS, et al. Compound EGFR mutation is frequently detected with co-mutations of actionable genes and associated with poor clinical outcome in lung adenocarcinoma. Cancer Biol Ther. 2016;17(3):237-245.  doi:10.1080/15384047.2016.1139235
4 Patil T, Mushtaq R, Marsh S, et al. Clinicopathologic characteristics, treatment outcomes, and acquired resistance patterns of atypical EGFR mutations and HER2 alterations in stage IV non-small-cell lung cancer. Clin Lung Cancer. 2020;21(3):e191-e204. doi:10.1016/j.cllc.2019.11.008
5 Fabrizio FP, Attili I, de Marinis F. Uncommon and Rare EGFR Mutations in Non-Small Cell Lung Cancer Patients with a Focus on Exon 20 Insertions and the Phase 3 PAPILLON Trial: The State of the Art. Cancers. 2024; 16(7):1331.  https://doi.org/10.3390/cancers16071331
6 Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838. doi:10.1016/S1470-2045(15)00026-1
7 GILOTRIF® (afatinib tablets), for oral use [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc.; 2022.
8 Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833
9 Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-0071 
10 Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116
11 Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.
12 RYBREVANT® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
13 ClinicalTrials.gov. A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (CHRYSALIS-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed May 2026.
14 The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed May 2026.
15 American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed May 2026.
16 Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
17 Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
18 Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 37:97-104.
19 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
20 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.
21 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.
22 American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed May 2026.
23 Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.
24 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.
25 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.
26 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
27 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed May 2026.
28 Cho BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217.
29 LAZCLUZE® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.Media contact:
Oncology Media Relations
oncology_media_relations@its.jnj.comInvestor contact:
Jess Margevich
investor-relations@its.jnj.com


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New TECVAYLI® (teclistamab-cqyv) data demonstrate superior progression-free and overall survival as early as first relapse in multiple myelomaMay 29, 2026 8:18 AM
PR Newswire (US) Building on the recent approval of Johnson & Johnson's TECVAYLI® plus DARZALEX FASPRO®, MajesTEC-9 is the second positive Phase 3 study to reinforce the strength of TECVAYLI® as early as second line TECVAYLI® delivered deep and durable responses with nearly two-thirds of patients achieving a complete response or betterCHICAGO, May 29, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-9 study demonstrating clinically meaningful and statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with TECVAYLI® (teclistamab-cqyv) versus standard of care regimens in patients with relapsed or refractory multiple myeloma treated as early as second line. In a patient population whose myeloma was predominantly refractory to anti-CD38 therapy and lenalidomide, TECVAYLI® reduced the risk of disease progression or death by 71% and the risk of death by 40%.1 These data (Abstract #7507) will be presented as an oral session today at the annual American Society of Clinical Oncology (ASCO) Annual Meeting, with simultaneous publication in The New England Journal of Medicine. Expert and company perspectives support the strength of TECVAYLI® "These findings further reinforce TECVAYLI's potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines," said Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University.* "These results will continue to transform the role of bispecifics in clinical decision-making as early as first relapse—offering a steroid-sparing, community-based therapy for patients across all practice settings, regardless of prior anti-CD38 exposure.""After the recent approval of TECVAYLI plus DARZALEX FASPRO, a potential new standard of care, these results add to the growing body of evidence reinforcing the clinical power of TECVAYLI earlier in the treatment paradigm," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "These findings further demonstrate how we're leading in multiple myeloma as we bring new options to better match the right therapy to the right patient at each stage of disease."MajesTEC-9 study results The MajesTEC-9 study evaluated TECVAYLI®, a bispecific T-cell engager antibody therapy, versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including lenalidomide and a CD38 monoclonal antibody.1 Efficacy benefits were observed in a heavily pre-treated population, including patients predominantly refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), and more than 90% of patients who were refractory to their last line of therapy.1 Treatment with TECVAYLI® demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR]=0.29; 95% confidence interval [CI], 0.23, 0.38) and a 40% reduction in the risk of death (HR=0.60; 95% CI, 0.43, 0.83)] compared to standard of care, demonstrating significant improvements in both PFS and OS.1 Additionally, all key secondary endpoints showed significant improvement with TECVAYLI® versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR; 65.9% vs. 16.8%).1The overall safety profile for TECVAYLI® in the study was consistent with its known safety profile. TECVAYLI® had similar rates of treatment-emergent adverse events (TEAEs) compared to standard of care (99.7% vs. 97.9%).1 Grade 3/4 TEAEs were reported by 84.9% of patients treated with TECVAYLI®, compared with 76.3% of patients receiving standard of care.1 Grade 5 TEAEs were uncommon across the two treatment groups (6.5% vs. 3.5%).1 The majority of Grade 5 TEAEs in both groups were due to infections (5.5% vs. 2.8%) and most occurred within the first six months of treatment initiation.1 Infections were more frequent with TECVAYLI® compared to standard of care (Grade 3/4, 41.6% vs. 29.0%); However, rates of Grade 3 or higher infections declined over time with disease control.1 Cytokine release syndrome occurred in 66.0% of patients treated with TECVAYLI®, mostly Grade 1 and managed with standard mitigation strategies.1 All events resolved and none led to treatment discontinuation.1 Immune effector cell-associated neurotoxicity syndrome was infrequent, occurring in 4.1% of patients and primarily Grade 1/2.1 Median duration of treatment on TECVAYLI® was almost two times longer than standard of care (13.1 vs 7.0 months).1Regulatory review and next steps Based on these results, Johnson & Johnson is working with regulatory bodies globally to consider TECVAYLI® as early as second line. Applications for regulatory approval have been submitted to the U.S. Food and Drug Administration and the European Medicines Agency (EMA).About the MajesTEC–9 Study
MajesTEC-9 (NCT05572515) is an ongoing, randomized Phase 3 study comparing teclistamab monotherapy with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received 1–3 prior lines including lenalidomide and CD38 monoclonal antibody. The primary endpoint is PFS; secondary endpoints include complete response or better (≥CR), duration of response (DoR), time to next treatment (TTNT), progression-free survival on next line of therapy (PFS2), overall survival (OS), safety, and patient-reported outcomes.About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.3 Multiple myeloma is the third most common blood cancer worldwide.4 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.5 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.7,8 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.9About TECVAYLI®TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.10In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with RRMM who achieved and maintained a complete response (CR) or better for a minimum of six months.In March 2026, the U.S. FDA approved TECVAYLI® in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The supplemental Biologics License Application was proactively selected for the Commissioner's National Priority Voucher Pilot Program and also granted the application Breakthrough Therapy Designation and Real-Time Oncology Review. This approval expanded the use of TECVAYLI® into earlier lines of therapy and is the first bispecific antibody-based combination regimen in this setting.To date, more than 26,000 patients have been treated worldwide with TECVAYLI®.The European Commission (EC) granted TECVAYLI® conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC approved a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months.For more information, visit www.TECVAYLI.com.About DARZALEX FASPRO® and DARZALEX®DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.11 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.12 In 2025, DARZALEX FASPRO® was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma.DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.5 DARZALEX®-based regimens have been used in the treatment of more than 748,000 patients worldwide and more than 68,000 patients in the U.S. alone.In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.For more information, visit www.DARZALEX.com.TECVAYLI® INDICATIONS AND IMPORTANT SAFETY INFORMATIONINDICATIONS AND USAGETECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma:in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.IMPORTANT SAFETY INFORMATIONWARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROMECytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity.Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity.TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY® Risk Evaluation and Mitigation Strategy (REMS).WARNINGS AND PRECAUTIONSCytokine Release Syndrome - TECVAYLI can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions.In the clinical trials (monotherapy and combination therapy; N=448), CRS occurred in 64% of patients who received TECVAYLI at the recommended dose, with Grade 1 CRS occurring in 46% of patients, Grade 2 in 18%, and Grade 3 in 0.2%. Recurrent CRS occurred in 27% of patients. Most patients experienced CRS during the initial step-up dosing schedule (step-up dose 1 [37%], step-up dose 2 [32%], or the initial treatment dose [20%]). CRS first occurred following subsequent doses of TECVAYLI in 2.5% of patients. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose and the median duration of CRS was 2 (range: 1 to 22) days.Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation).Initiate therapy according to TECVAYLI step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI accordingly.At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI based on severity.TECVAYLI is available only through a restricted program under a REMS.Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome - TECVAYLI can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in 60% of patients who received TECVAYLI at the recommended dosage, with Grade 3 or 4 neurologic toxicity in 6%. Neurologic toxicities reported in ≥5% of patients included headache (27%), sensory neuropathy (16%), motor dysfunction (15%), insomnia (12%), encephalopathy (11%), and dizziness (8%). Fatal neurologic toxicity occurred in 0.4% of patients, including Guillain-Barré syndrome and status epilepticus (one patient each).In MajesTEC-1, ICANS was reported in 6% of patients who received TECVAYLI as monotherapy at the recommended dosage. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent TECVAYLI doses. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia.In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. All events of ICANS occurred during the step-up dosing schedule. The median time to onset of ICANS was 2 (range: 1 to 3) days after the most recent dose and the median duration of ICANS was 2 (range: 1 to 2) days. The clinical manifestations of ICANS reported were amnesia, encephalopathy and delirium.The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during TECVAYLI treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves or permanently discontinue TECVAYLI based on severity per recommendations and consider further management per current practice guidelines.Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.TECVAYLI is available only through a restricted program under a REMS.TECVAYLI and TALVEY REMS - TECVAYLI is available only through a restricted program under a REMS called the TECVAYLI and TALVEY REMS because of the risks of CRS and neurologic toxicity, including ICANS.Hepatotoxicity - TECVAYLI can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI at the recommended dose in the clinical trials (monotherapy and combination therapy trials; N=448) elevated aspartate aminotransferase (AST) occurred in 47% of patients, with Grade 3 or 4 elevations in 2.9%. Elevated alanine aminotransferase (ALT) occurred in 48% of patients, with Grade 3 or 4 elevations in 3.8%. Elevated total bilirubin occurred in 10% of patients with Grade 3 or 4 elevations in 0.7%. Liver enzyme elevation can occur with or without concurrent CRS.Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Infections - TECVAYLI can cause severe, life-threatening, or fatal infections.In MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI dosage, serious infections, including opportunistic infections, occurred in 30% of patients, Grade 3 or 4 infections in 35% of patients, and fatal infections in 4.2% of patients.In MajesTEC-3 (N=283), in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in 54% of patients, Grade 3 or Grade 4 infections in 54% of patients, and fatal infections in 4.6% of patients.Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines.Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Monitor immunoglobulin levels prior to and during treatment with TECVAYLI and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 mg/dL.Neutropenia - TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dose in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients.Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines.Monitor patients with neutropenia for signs of infection.Withhold TECVAYLI based on severity.Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions.Systemic Reactions - In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic-administration reactions, which included recurrent pyrexia and rash.Local Reactions - In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%.Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose.ADVERSE REACTIONS
The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased.The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI.DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONSDARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapyIn combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyIn combination with bortezomib and dexamethasone in patients who have received at least one prior therapyAs monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agentDARZALEX FASPRO® as monotherapy is indicated for the treatment of adult patients with high-risk smoldering multiple myeloma.IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS  DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.  WARNINGS AND PRECAUTIONS  Hypersensitivity and Other Administration Reactions  Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®. Systemic Reactions  In a pooled safety population of 1446 patients with multiple myeloma (N=1235) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3%, Grade 3: 0.8%, Grade 4: 0.1%). In patients with high-risk smoldering multiple myeloma (N=193), systemic administration-related reactions occurred in 17% of patients in AQUILA (Grade 2: 7%, Grade 3: 1%).In all patients (N=1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.  Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.  Local ReactionsIn this pooled safety population of 1446 patients with multiple myeloma (N=1253) or light chain amyloidosis (N=193), injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 1.1%. The most frequent (>1%) injection-site reaction were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.InfectionsDARZALEX FASPRO® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%).Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX FASPRO® and treat appropriately. Administer prophylactic antimicrobials according to guidelines.Neutropenia  Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.  Thrombocytopenia  Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO® until recovery of platelets.  Embryo-Fetal Toxicity  Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose.  The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.  Interference With Serological Testing  Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.  Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®.  Interference With Determination of Complete Response  Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein.  ADVERSE REACTIONS  In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, rash, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, upper respiratory tract infection, , peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, peripheral edema, and anemia.The most common adverse reactions (≥20%) in patients with high-risk smoldering multiple myeloma who received DARZALEX FASPRO® monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.  Please click here to read the full Prescribing Information for DARZALEX FASPRO®.  DARZALEX® INDICATIONS AND IMPORTANT SAFETY INFORMATIONINDICATIONSDARZALEX® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplantIn combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapyIn combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplantIn combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitorIn combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyIn combination with bortezomib and dexamethasone in patients who have received at least one prior therapyAs monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agentCONTRAINDICATIONSDARZALEX® is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.WARNINGS AND PRECAUTIONSInfusion-Related ReactionsDARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension and blurred vision.When DARZALEX® dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4:

FDA approves label expansion, cementing TREMFYA® as the only IL-23 inhibitor proven to help stop further joint damageMay 28, 2026 7:10 PM
PR Newswire (US) TREMFYA® showed significant inhibition of structural joint damage in adults with active psoriatic arthritisHORSHAM, Pa., May 28, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA® (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA). The inclusion of this key outcome reflects that TREMFYA is the only IL-23 inhibitor proven to help stop further structural damage, offering patients with active PsA a first-line treatment option that provides effective symptom control and no new safety signals, while significantly inhibiting irreversible joint damage. "Joint damage associated with active psoriatic arthritis can happen as soon as six months after onset of disease, so it's important to have treatment solutions that can help provide daily symptom relief while also protecting joints from long-term structural damage," said Philip J. Mease,a M.D., Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA. "With the inclusion of these findings in the label, we now have stronger clinical evidence that sets TREMFYA apart as a treatment option for patients with active psoriatic arthritis at risk for joint damage."The label update is supported by 24-week results from the Phase 3b APEX study. The study met its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibiting progression of structural damage, as measured by change in the PsA-modified van der Heijde-Sharp (vdH-S) scoreb, compared to placebo in bio-naïve patients.1,2,3Additionally, for patients in the study's placebo group who switched to TREMFYA at Week 24, the rate of radiographic progression was reduced by 57% from Week 24 through Week 48, demonstrating benefit even after initial disease progression. Data from the APEX study were consistent with the well-established safety profile of TREMFYA, with no new safety signals identified.4"Up to half of all patients living with active psoriatic arthritis can develop early irreversible joint damage, leaving them unable to perform simple daily tasks or go to work," said Brandee Pappalardo, Ph.D., M.P.H., Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. "This label update reinforces our commitment to advancing innovation for these patients by offering the only IL-23 inhibitor with structural inhibition in its label, making TREMFYA a differentiated treatment option for symptom relief and joint preservation that helps address the progressive nature of active psoriatic arthritis."TREMFYA is the only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocytes, macrophages, and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA, moderate to severe plaque psoriasis (PsO), moderate to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Findings are based on in vitro.5,6,7,8,9Editor's notes: 
a. Dr. Philip Mease is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
b. VdH-S scores are from the Week 48 x-ray read.ABOUT APEX (NCT04882098)
APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment is scheduled prior to the final safety follow-up.10ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).11,12,13 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.14 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.15 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.16 Studies show up to 30% of people with plaque PsO also develop PsA.10ABOUT TREMFYA (guselkumab)
Developed by Johnson & Johnson, TREMFYA is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.TREMFYA is a prescription medicine approved in the U.S. to treat:adults and children 6 years of age and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.adults with moderately to severely active ulcerative colitis.adults with moderately to severely active Crohn's disease.TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.The legal manufacturer for TREMFYA is Janssen Biotech, Inc.Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit: www.tremfya.com.TREMFYA® IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including:Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure)swelling of your face, eyelids, lips, mouth, tongue or throat  trouble breathing or throat tightnesschest tightnessskin rash, hivesitching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.          Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chillsmuscle achesweight losscoughwarm, red, or painful skin or sores on your body different from your psoriasis  diarrhea or stomach painshortness of breathblood in your phlegm (mucus)burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. With the treatment of plaque psoriasis or psoriatic arthritis, your healthcare provider may do blood tests to check your liver before and as necessary during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rashvomitingtiredness (fatigue)yellowing of the skin or the whites of your eyes  nauseastomach pain (abdominal)loss of appetitedark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?"have an infection that does not go away or that keeps coming back.have TB or have been in close contact with someone with TB.have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. Children should be brought up to date with all vaccines before starting TREMFYA®are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy.are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.          Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.What are the possible side effects of TREMFYA®?TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?"The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, bronchitis, feeling very tired (fatigue), fever (pyrexia), and skin rash.These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.Use TREMFYA® exactly as your healthcare provider tells you to use it.Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/ or at https://www.jnj.com/innovativemedicine/.Follow us at @JNJInnovMed.© Johnson & Johnson and its affiliates 2026. All rights reserved.CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.1 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Abstract presented at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain. Late-Breaking Abstracts Session II.
2 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: Results through Week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Oral presentation at: European Alliance of Associations for Rheumatology (EULAR) 2025 Congress; June 11-14, 2025; Barcelona, Spain.
3 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. 2025;84(12):1983-1994. 
4 Ritchlin CT, et al. Durable Inhibition of Structural Damage Progression and Improvements in Joint Disease Activity With the Selective Interleukin-23 Inhibitor Guselkumab in Active and Erosive Psoriatic Arthritis: Week 48 Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Presented at ISDS 2025. November 12-15. Poster 331.
5 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.
6 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
7 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
8 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.
9 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
10 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed May 2026.
11 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed May 2026.
12 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed May 2026.
13 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed May 2026.
14 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed May 2026.
15 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed May 2026.
16 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed May 2026.Media contact: 
Camilia Aberra caberra@its.jnj.com  

Investor contact: Jess Margevichinvestor-relations@its.jnj.com   
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