Merck to Participate in the Wells Fargo 21st Annual Healthcare ConferenceSeptember 2, 2026 6:45 AM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Caroline Litchfield, executive vice president and chief financial officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Wells Fargo 21st Annual Healthcare Conference on Wednesday, Sept. 09, 2026, at 2:15 p.m. ET. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260902454334/en/ Media Contacts: John Cummins
john.cummins2@merck.com Michael Levey
michael.levey @Edwin48 Steven Graziano
(732) 594-1583 Original: Merck to Participate in the Wells Fargo 21st Annual Healthcare Conference

Wrong board—Merck KGaA is a different company.

Merck KGaA shares rise 1.7% after HSBC upgrades stock to BuySeptember 1, 2026 6:44 AM
IH Market News Merck KGaA (NYSE:MRK) shares rose 1.7% to €141.30 after HSBC upgraded its rating on the Darmstadt-based science and technology group to “Buy” from “Hold”. HSBC also named Merck KGaA among its preferred companies in the life sciences tools sector, alongside Lonza, Danaher and Agilent. Analysts cited the company’s valuation, first-half 2026 growth and its performance relative to the recent broader sector rally among the reasons for the upgrade. Second-quarter organic sales growth accelerates Merck KGaA reported second-quarter 2026 results in early August, with organic sales growth increasing to 4.1% from 2.9% during the first quarter. Within the business, Life Science Process Solutions recorded organic growth of 15%. The company also raised its full-year 2026 outlook when it reported the quarterly results. The Life Science and Electronics divisions have contributed to the company’s recent growth, factors that HSBC considered as part of its assessment of the stock. Shares advance as broader equity markets decline Merck KGaA’s gain came during a session in which major U.S. equity indices moved lower. The S&P 500 declined 0.6%, while the Nasdaq fell more than 1.0%. At €141.30, Merck KGaA shares remained below their 52-week high of €148.80. HSBC’s upgrade followed the company’s improved organic sales growth in the second quarter and its increased full-year guidance, while the brokerage also highlighted the stock’s recent performance relative to other companies in the sector. Merck stock price The post Merck KGaA shares rise 1.7% after HSBC upgrades stock to Buy appeared first on US Editors. Original: Merck KGaA shares rise 1.7% after HSBC upgrades stock to Buy

Moderna Shares Surge More Than 90% After Phase 3 Melanoma Trial SuccessAugust 19, 2026 9:29 AM
IH Market News Moderna Inc (NASDAQ:MRNA) shares surged more than 90% in Wednesday pre-market trading after the biotechnology company and Merck (NYSE:MRK) reported positive Phase 3 results for their melanoma treatment combination, which performed better than Keytruda alone. The INTerpath-001 study evaluated intismeran autogene, an investigational mRNA-based individualised neoantigen therapy, in combination with Merck’s Keytruda in patients with completely resected stage IIB-IV melanoma. The trial achieved its primary endpoint of recurrence-free survival, as well as the key secondary endpoint of distant metastasis-free survival. “We are upgrading shares to Outperform from Market Perform given that we believe Moderna has a clear line of sight to revenue diversification from the COVID business now,” William Blair analyst Myles Minter said in a note. Compared with Keytruda alone, the combination delivered statistically significant improvements across both measures in patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not previously received systemic therapy. The results represent the first successful Phase 3 readout for an individualised neoantigen therapy and an mRNA-based cancer treatment. The study is also the first Phase 3 trial to demonstrate a clinically meaningful improvement over Keytruda alone in the adjuvant treatment of patients with resected melanoma. No new safety concerns emerged from the trial, with the safety profiles of intismeran and Keytruda remaining consistent with findings from earlier studies. Researchers will continue assessing additional key secondary endpoints, including overall survival. Moderna and Merck intend to present the findings at a forthcoming international medical conference and submit the results to regulatory authorities. The two companies are also evaluating their treatment approach more broadly, with nine Phase 2 and Phase 3 trials currently underway across several tumour types. These include melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. Moderna stock price Merck stock priceThe post Moderna Shares Surge More Than 90% After Phase 3 Melanoma Trial Success appeared first on US Editors. Original: Moderna Shares Surge More Than 90% After Phase 3 Melanoma Trial Success

Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA® Met Endpoints of Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS) in Patients With Completely Resected Stage IIB-IV MelanomaAugust 19, 2026 6:45 AM
Business Wire First and only combination regimen to demonstrate statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for these patients in the adjuvant melanoma setting The Companies plan to present data at an upcoming international medical meeting and will engage with regulators on filing submissions for intismeran autogene in combination with KEYTRUDA Intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed specifically for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (NASDAQ: MRNA) today announced positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma. The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). This represents the first positive Phase 3 readout for an individualized neoantigen therapy (INT) and for an mRNA-based cancer therapy, as well as the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone, a standard-of-care immunotherapy, in the adjuvant setting for patients with resected melanoma. At a pre-specified interim analysis, intismeran in combination with KEYTRUDA as adjuvant therapy demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not undergone prior treatment with systemic therapy. In accordance with the trial protocol, the study will continue in order to evaluate other key secondary endpoints, including overall survival (OS). The safety profiles of intismeran and KEYTRUDA in this trial were consistent with those observed in previously reported studies for the combination, with no new safety signals observed. These data will be presented at an upcoming international medical meeting and shared with regulatory authorities. “Today’s results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint' of a patient's own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to KEYTRUDA alone,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia, Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney. “Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer.” “By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment. We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated. Together with Moderna, we look forward to presenting data from INTerpath-001 at an international medical meeting and sharing with regulatory authorities.” “These Phase 3 findings represent a pivotal moment for the field of cancer research. For many years, the idea of creating an mRNA treatment designed specifically for an individual patient's cancer was aspirational. We are now helping turn that vision into a reality,” said Stéphane Bancel, CEO of Moderna. “Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting. We are deeply grateful to the patients, investigators and study teams whose contributions make this progress possible.” Merck and Moderna are advancing the robust INTerpath clinical development program evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. Additional clinical studies include the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC. Today’s Phase 3 readout builds on previously reported Phase 2b results for intismeran in combination with KEYTRUDA from the KEYNOTE-942/mRNA-4157-P201 trial, including the five-year follow-up data presented at the 2026 ASCO Annual Meeting, in which the combination demonstrated a 49% reduction in the risk of recurrence or death (HR=0.51; [95% CI, 0.294-0.887]) and a 59% reduction in the risk of distant metastasis or death (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone. About INTerpath-001
INTerpath-001 is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial (ClinicalTrials.gov, NCT05933577) evaluating the safety and efficacy of intismeran in combination with KEYTRUDA compared to KEYTRUDA alone in patients with high-risk (stage IIB-IV) resected cutaneous melanoma. The trial enrolled 1,137 patients who, following complete surgical resection, were randomized 2:1 to receive intismeran (1 mg every three weeks for up to nine doses) and KEYTRUDA (400 mg every six weeks up to nine cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever was sooner. The primary endpoint is RFS, defined as the time from randomization to any disease recurrence (local, locoregional, regional or distant) as assessed by the investigator, or death due to any cause. Key secondary endpoints include DMFS, OS, safety, tolerability and quality of life. About intismeran autogene
Intismeran autogene (intismeran; V940 or mRNA-4157) is a novel, potential first-in-class investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. Intismeran is designed and produced using a patient's tumor sample to identify the unique mutational signature, or "fingerprint," of their cancer and generate an anti-tumor immune response. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient's tumor. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient's tumor. About melanoma
Melanoma, one of the deadliest forms of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026 alone. Despite advances in treatment, patients with resected melanoma remain at risk of disease recurrence, which most often occurs within the first two years. The majority of recurrences are metastatic rather than localized, highlighting the ongoing need for treatment approaches that may help reduce the risk of recurrence and improve long-term outcomes. About Merck’s research in melanoma
Merck is committed to delivering meaningful advances for patients with melanoma and to continuing research in skin cancers through a broad clinical development program across investigational and approved medicines. KEYTRUDA has been established as an important treatment option for the adjuvant treatment of patients with resected Stage IIB, IIC, or III melanoma based on results of KEYNOTE-054 and KEYNOTE-716. KEYTRUDA is also approved worldwide for the treatment of patients with unresectable or metastatic melanoma. Leveraging a decade of melanoma clinical trials, Merck continues to explore both innovative treatment approaches, including investigational individualized neoantigen therapies, and novel KEYTRUDA combinations with the goal of further improving long-term outcomes for people living with melanoma. About Merck’s early-stage cancer clinical program
Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

U.S. FDA Accepts sBLA for ENFLONSIA™ (clesrovimab-cfor) to Update its Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease Indication to Include Children Under Two Years at Increased Risk for Severe RSV for Their Second SeasonAugust 6, 2026 6:45 AM
Business Wire EMA also accepts application for the same population for ENFLONSIA based on results from the Phase 3 SMART trial If approved, children under two years of age at increased risk for severe RSV disease will be eligible to receive an additional dose of ENFLONSIA for their second RSV season Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for ENFLONSIA™ (clesrovimab-cfor) to expand its indication to include prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under two years of age at increased risk for severe RSV disease through their second RSV season. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of March 22, 2027. In July 2026, the European Medicines Agency (EMA) accepted the application to expand marketing authorization for ENFLONSIA in the European Union (EU) for the same population. ENFLONSIA was approved by the U.S. FDA in June 2025 and by the European Commission in April 2026 for the prevention of RSV LRTD in infants born during or entering their first RSV season. ENFLONSIA is the first and only preventive option against RSV LRTD administered to infants without the need for weight-based dosing. “For some children, the potentially serious impact of RSV does not stop after their first RSV season,” said Dr. Macaya Douoguih, vice president, Therapeutic Area Head, Global Clinical Development, Merck Research Laboratories. “The recent FDA and EMA regulatory filings represent important opportunities to help expand protection with ENFLONSIA for vulnerable children under two years of age during their second RSV season – potentially further reducing the significant burden of RSV on families and health care systems.” Even with protection during their first RSV season, certain children – including those born with chronic lung disease, congenital heart disease or early or moderate preterm birth with certain risk conditions – remain vulnerable to severe RSV disease during their second RSV season. Both the U.S. and EU applications are supported by data from the Phase 3 SMART trial (MK-1654-007), which were presented at RSVVW’26, the 9th conference of the Respiratory Syncytial Virus Foundation (ReSViNET), in February 2026 and published in the New England Journal of Medicine in September 2025 (interim RSV season 1 results) and JAMA Pediatrics in July 2026 (full results). ENFLONSIA is approved in more than 40 countries worldwide, including the United States, Canada, the European Union, China and Japan, for use in infants during their first RSV season. Regulatory filings are underway for approval in additional countries globally, as well as for indication expansion where already approved. About the Phase 3 SMART Trial
The SMART trial (MK-1654-007) (NCT04938830) was a Phase 3, randomized, partially-blind, palivizumab-controlled, multicenter study to evaluate the safety, efficacy and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV disease over two RSV seasons. The trial enrolled early (

Health Canada Approves KEYTRUDA® for the treatment of adult patients with muscle invasive bladder cancer who are ineligible for cisplatin containing chemotherapy, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after raAugust 5, 2026 11:00 AM
PR Newswire (Canada) KIRKLAND, QC, Aug. 4, 2026 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab for injection), Merck's anti-PD-1 therapy, in combination with enfortumab vedotin, an antibody-drug conjugate (ADC), is approved by Health Canada as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. The trial demonstrated a statistically significant improvement in EFS and OS in patients treated with neoadjuvant and adjuvant KEYTRUDA in combination with enfortumab vedotin compared with RC and PLND alone. It also demonstrated a statistically significant difference in pCR rate."Muscle-invasive bladder cancer can have a significant impact on patients and their families, particularly for those who are not candidates for cisplatin-based chemotherapy," said Michelle Colero, Executive Director at Bladder Cancer Canada. "The availability of an additional treatment option for eligible patients is welcome news for the bladder cancer community and highlights the importance of continued research in this area of unmet need."About bladder cancerBladder cancer is the fifth most commonly diagnosed cancer in Canada, and 13,400 individuals are diagnosed each year with the disease, according to Bladder Cancer Canada. Around one-quarter (25%) of these newly diagnosed cases involve muscle-invasive bladder cancer (MIBC), where the cancer grows through the lining of the bladder into or through the muscle layer of the bladder wall.For patients with MIBC, cisplatin-based neoadjuvant chemotherapy followed by surgery (radical cystectomy) is a standard treatment approach in Canada. Cisplatin ineligibility is common in this population and may be related to factors such as age or certain medical conditions. For patients who are not eligible for cisplatin-containing chemotherapy, treatment decisions have traditionally centered on proceeding to radical cystectomy alone.About MerckAt Merck, known as MSD, outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn @MerckCanada.Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USAThis news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2025 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).® Merck Sharp & Dohme LLC. Used under license.
© 2026 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.Media Requests:
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mediacanada@merck.comSOURCE Merck Original: Health Canada Approves KEYTRUDA® for the treatment of adult patients with muscle invasive bladder cancer who are ineligible for cisplatin containing chemotherapy, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after ra

Santé Canada a approuvé l'indication de KEYTRUDA® pour le traitement des patients adultes atteints d'un cancer de la vessie invasif sur le plan musculaire (CVIM) qui ne sont pas admissibles à une chimiothérapie à base de cisplatine, en association avAugust 5, 2026 11:00 AM
PR Newswire (Canada) KIRKLAND, QC, le 5 août 2026 /CNW/ -- Merck (NYSE : MRK), connue sous le nom de MSD à l'extérieur des États-Unis et du Canada, a annoncé que KEYTRUDA® (pembrolizumab pour injection), le traitement anti-PD-1 de Merck, en association avec l'enfortumab védotine, un conjugué anticorps-médicament (CAM), a été approuvé par Santé Canada à titre de traitement néoadjuvant, puis à titre de traitement adjuvant après une cystectomie radicale (CR), chez les adultes atteints d'un cancer de la vessie invasif sur le plan musculaire (CVIM) qui ne sont pas admissibles à une chimiothérapie à base de cisplatine. Cette autorisation repose sur les résultats de l'étude pivot de phase III KEYNOTE-905 (également connue sous le nom d'EV-303), menée en collaboration avec Pfizer et Astellas. L'étude a démontré une amélioration statistiquement significative de la SSE et de la SG chez les patients recevant un traitement néoadjuvant et adjuvant par KEYTRUDA® en association avec l'enfortumab védotine, comparativement à une cystectomie radicale et une dissection des ganglions lymphatiques pelviens seulement. Elle a également mis en évidence une différence statistiquement significative dans le taux de RPc.« Le cancer de la vessie invasif sur le plan musculaire peut avoir des répercussions importantes sur les patients et leurs familles, en particulier pour ceux qui ne sont pas admissibles à une chimiothérapie à base de cisplatine, a déclaré Michelle Colero, directrice générale de Cancer de la vessie Canada. La disponibilité d'une option thérapeutique supplémentaire pour les patients admissibles est une bonne nouvelle pour la communauté des personnes touchées par le cancer de la vessie et souligne l'importance de poursuivre la recherche dans ce domaine, où les besoins ne sont pas encore comblés. »À propos du cancer de la vessieLe cancer de la vessie est le cinquième cancer le plus fréquemment diagnostiqué au Canada et 13 400 personnes reçoivent chaque année un diagnostic de cette maladie, selon Cancer de la vessie Canada. Environ un quart (25 %) de ces nouveaux cas diagnostiqués concernent un cancer de la vessie invasif sur le plan musculaire (CVIM), dans lequel la tumeur traverse la muqueuse de la vessie pour atteindre, voire traverser, la couche musculaire de la paroi vésicale.Chez les patients atteints d'un CVIM, la chimiothérapie néoadjuvante à base de cisplatine, suivie d'une intervention chirurgicale (cystectomie radicale), constitue l'approche thérapeutique standard au Canada. La non-admissibilité à la chimiothérapie à base de cisplatine est fréquente dans cette population et peut être liée à des facteurs comme l'âge ou certaines affections médicales. Pour les patients qui ne sont pas admissibles à une chimiothérapie à base de cisplatine, les décisions thérapeutiques ont traditionnellement consisté à opter uniquement pour une cystectomie radicale.À propos de MerckChez Merck, aussi connue sous le nom de MSD à l'extérieur des États-Unis et du Canada, nous unissons nos forces dans un seul but : nous utilisons le pouvoir de la science moderne pour sauver et améliorer des vies dans le monde entier. Nous apportons de l'espoir à l'humanité par le biais du développement de médicaments et de vaccins importants depuis plus de 130 ans. Nous aspirons à devenir le chef de file dans le domaine de la recherche biopharmaceutique à travers la planète. Les solutions novatrices en matière de santé, que nous apportons de nos jours, sont d'ailleurs à la fine pointe de la recherche, permettant ainsi de faire avancer les techniques utilisées en prévention et d'améliorer les traitements des maladies chez l'homme et l'animal. Nous encourageons l'emploi d'une main-d'œuvre diversifiée et inclusive à l'échelle mondiale, et nous opérons de façon responsable chaque jour pour assurer un avenir sécuritaire, durable et sain aux personnes et aux communautés. Pour en savoir plus sur nos activités au Canada, visitez le www.merck.ca ou suivez-nous sur LinkedIn @MerckCanada.Déclarations prospectives de Merck & Co., Inc., Rahway, NJ, É.-U.Ce communiqué de Merck & Co., Inc., Rahway, NJ, É.-U. (la Société) comprend des déclarations prospectives au sens des dispositions libératoires de la Private Securities Litigation Reform Act de 1995 des États-Unis. Ces déclarations sont fondées sur les convictions et les prévisions actuelles de la direction de la Société et sont soumises à de nombreux risques et incertitudes. Si les hypothèses sous-jacentes se révèlent inexactes ou si les risques et incertitudes se concrétisent, les résultats réels pourraient être considérablement différents de ceux annoncés dans les déclarations prospectives.Ces risques et incertitudes comprennent, sans s'y limiter, les conditions générales du secteur et la concurrence, les facteurs économiques généraux, incluant les fluctuations des taux d'intérêt et des taux de change; les effets de la réglementation du secteur pharmaceutique ou des lois concernant les soins de la santé aux États-Unis et dans le monde; les tendances mondiales à l'égard de la limitation des coûts des soins de santé; les avancées technologiques et les nouveaux produits et brevets des concurrents; les défis liés à l'élaboration d'un nouveau produit, ce qui inclut l'obtention de l'approbation réglementaire; la capacité de la Société à prédire précisément les conditions de marché futures; les difficultés ou les retards de fabrication; l'instabilité financière des économies mondiales et le risque de souveraineté; la dépendance à l'égard de l'efficacité des brevets de la Société et des autres protections relatives aux produits innovants; et le risque de faire l'objet d'actions judiciaires ou de mesures réglementaires.La Société ne s'engage aucunement à publier des mises à jour de ses déclarations prospectives à la suite de nouvelles informations, d'événements futurs ou de quelque fait que ce soit. D'autres facteurs susceptibles d'entraîner une différence notable entre les résultats réels et les résultats décrits dans les déclarations prospectives sont énoncés dans le rapport annuel de la Société pour l'exercice clos le 31 décembre 2025 établi sur le formulaire 10-K et dans les autres documents déposés par la Société auprès de la Securities and Exchange Commission (SEC) des États-Unis et accessibles sur le site Internet de cette dernière (www.sec.gov).® Merck Sharp & Dohme LLC, utilisée sous licence.
© 2026 Merck & Co., Inc., Rahway, NJ, É.-U. et ses sociétés affiliées. Tous droits réservés.Demandes médiatiques :
Centre des médias de Merck Canada 
1-833-906-3725
mediacanada@merck.com SOURCE Merck Original: Santé Canada a approuvé l'indication de KEYTRUDA® pour le traitement des patients adultes atteints d'un cancer de la vessie invasif sur le plan musculaire (CVIM) qui ne sont pas admissibles à une chimiothérapie à base de cisplatine, en association av

Merck Shares Advance After Strong Second-Quarter Earnings and Higher Revenue OutlookAugust 4, 2026 8:19 AM
IH Market News Merck (NYSE:MRK) shares moved higher in pre-market trading after the pharmaceutical company reported second-quarter 2026 results that exceeded Wall Street expectations and raised its full-year revenue guidance. Although Merck reduced its adjusted earnings outlook to reflect acquisition-related charges, investors welcomed the stronger-than-expected quarterly performance and improved sales forecast. Revenue and Earnings Beat Expectations Merck reported a loss of $0.13 per share for the second quarter, outperforming analyst expectations for a loss of $0.27 per share. Revenue reached $16.6 billion, representing 4% growth excluding the impact of foreign exchange movements and exceeding the consensus estimate of $16.41 billion. Following the earnings release, Merck shares gained 1.4% in pre-market trading. Key Products Continue to Drive Growth Sales of Keytruda and Keytruda Qlex totalled $8.4 billion during the quarter, increasing 4% on a constant-currency basis. The figure included $463 million in revenue from Keytruda Qlex, while sales of Winrevair climbed 75% on a constant-currency basis to $588 million. Chairman and Chief Executive Officer Robert Davis highlighted the company’s continued execution and product momentum. “We continued to make substantial progress across our business this quarter, driven by strong execution and growing contributions from new product launches,” he said. Acquisition Costs Impact Earnings Outlook Merck lowered its full-year 2026 adjusted earnings per share guidance to between $2.66 and $2.76, compared with its previous forecast of $5.04 to $5.16. The revised outlook is broadly in line with the current analyst consensus estimate of $2.76 per share. Management said the reduction reflects acquisition-related charges of $2.43 per share linked to the purchase of Terns. These include a one-time charge of $2.31 per share and approximately $0.12 per share in financing costs and investment associated with advancing MK-4208, previously known as TERN-701. Company Raises Full-Year Sales Forecast Despite lowering its earnings guidance, Merck increased its revenue outlook for the full year. The company now expects worldwide sales of between $66.3 billion and $67.3 billion during 2026, compared with its previous guidance of $65.8 billion to $67.0 billion. The updated forecast is also ahead of the analyst consensus estimate of approximately $66.89 billion. Expenses Expected to Increase Merck now expects its full-year gross margin to be approximately 81%, slightly below its previous estimate of around 82%. The company also increased its operating expense forecast to between $42.0 billion and $42.7 billion, compared with its earlier guidance of $36.0 billion to $36.8 billion, primarily reflecting costs associated with the Terns acquisition and continued investment in its product pipeline. Merck stock priceThe post Merck Shares Advance After Strong Second-Quarter Earnings and Higher Revenue Outlook appeared first on US Editors. Original: Merck Shares Advance After Strong Second-Quarter Earnings and Higher Revenue Outlook

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse PipelineAugust 4, 2026 6:30 AM
Business Wire Sales Growth Reflects Continued Strength in Oncology, Including Initial Uptake of KEYTRUDA QLEX, and Animal Health, Plus Contributions From Launches Such as WINREVAIR Financial Highlights Total Worldwide Sales Were $16.6 Billion (5% Growth; 4% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX1 Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $463 Million WINREVAIR Sales Were $588 Million (75% Growth; 75% Growth ex-FX) Animal Health Sales Were $1.8 Billion (8% Growth; 5% Growth ex-FX) GAAP Loss per Share Was $0.54; Non-GAAP Loss per Share Was $0.13; GAAP and Non-GAAP Loss per Share Include a Charge of $2.31 per Share for the Acquisition of Terns Pipeline & Portfolio Highlights Received U.S. FDA Approval for LIPFENDRA (enlicitide), the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia Announced Positive Data From TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (sac-TMT) in Certain Patients With Advanced or Recurrent Endometrial Cancer Announced Positive Phase 3 Results From Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir, in Collaboration With Gilead Full-Year 2026 Financial Outlook Narrows and Raises Expected Worldwide Sales Range To Be Between $66.3 Billion and $67.3 Billion Now Expects Non-GAAP EPS To Be Between $2.66 and $2.76; Outlook Includes Charges of $2.43 per Share for the Acquisition of Terns, Comprised of a One-Time Charge of $2.31 per Share as Well as Costs of Approximately $0.12 per Share To Finance the Acquisition and Advance MK-4208 (Formerly TERN-701) Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2026. “We continued to make substantial progress across our business this quarter, driven by strong execution and growing contributions from new product launches,” said Robert M. Davis, chairman and chief executive officer. “The FDA approval of LIPFENDRA is an exciting moment for our company and for patients, marking the latest milestone in our nearly 70-year legacy in cardiovascular disease. Together with key regulatory and clinical advances across oncology, HIV and immunology, this achievement reflects the strength of our pipeline and portfolio transformation as we bring forward the next wave of innovation. I am confident in the ongoing execution of our strategy as we deliver for patients and further enhance our long-term growth trajectory.” Financial Summary $ in millions, except EPS amounts Second Quarter 2026  2025  Change Change Ex- Exchange Sales $16,607  $15,806  5%  4%  GAAP net (loss) income2 (1,335)  4,427  N/M  N/M  Non-GAAP net (loss) income that excludes certain items2,3* (330)  5,366  N/M  N/M  GAAP EPS (0.54)  1.76  N/M  N/M  Non-GAAP EPS that excludes certain items3* (0.13)  2.13  N/M  N/M  *Refer to table on page 7. N/M - Not meaningful For the second quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $0.54 and non-GAAP loss per share was $0.13. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Terns Pharmaceuticals, Inc. (Terns) of $2.31 per share. Both GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment related to a license agreement with Jiangsu Hengrui Pharmaceutical Co., Ltd. (Hengrui Pharma). Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit reserve adjustments. Year-to-date results can be found in the attached tables. Second-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.   Second Quarter $ in millions 2026  2025  Change Change Ex-Exchange Commentary Total Sales $16,607  $15,806  5%  4%    Pharmaceutical 14,760  14,050  5%  4%  Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in diabetes. KEYTRUDA/
KEYTRUDA QLEX 8,366  7,956  5%  4%  Growth primarily driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), cervical cancer, head and neck cancer and bladder cancer, as well as higher global demand in metastatic indications, including urothelial cancer. Sales of KEYTRUDA QLEX were $463 million. GARDASIL/
GARDASIL 9 1,169  1,126  4%  3%  Increase primarily due to higher demand in Asia Pacific and Europe, as well as favorable timing of tenders in Europe, partially offset by lower demand in certain other international markets. PROQUAD, M-M-R II and VARIVAX 592  609  -3%  -3%  Decrease primarily reflects lower demand in the U.S., partially offset by higher net pricing in the U.S., higher demand in Europe and favorable private-sector purchasing patterns for M-M-R II in the U.S. WINREVAIR 588  336  75%  75%  Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe. BRIDION 497  461  8%  8%  Growth primarily due to higher demand and net pricing in the U.S. JANUVIA/JANUMET 429  623  -31%  -31%  Decline primarily due to lower demand and net pricing in the U.S. due to competition, as well as lower demand in China and most other international markets due to ongoing generic competition. Lynparza* 365  370  -1%  -2%  Relatively flat compared with prior year. PREVYMIS 295  228  29%  28%  Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications. Lenvima* 283  265  7%  6%  Growth primarily due to higher demand in the U.S., partially offset by lower net pricing. WELIREG 271  162  67%  67%  Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan, as well as favorable wholesaler purchasing patterns in the U.S. OHTUVAYRE 204  -  -  -  Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc. Includes a benefit from the timing of specialty pharmacy purchases in the U.S. CAPVAXIVE 184  129  42%  40%  Increase primarily driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, as well as in the U.S. VAXNEUVANCE 148  229  -35%  -36%  Decline primarily due to favorable prior period public-sector activity in the U.S., which increased sales in that period, as well as lower demand in the U.S. and in most international markets in the current period due to competitive pressure. LAGEVRIO 5  83  -95%  -95%  Decline largely due to lower demand in Japan and the U.S. Animal Health 1,775  1,646  8%  5%  Growth attributable to both Livestock and Companion Animal product portfolios. Livestock 1,041  961  8%  6%  Growth primarily driven by higher demand for ruminant and poultry products. Companion Animal 734  685  7%  5%  Growth primarily due to new product launches. Sales of BRAVECTO line of products were $359 million and $335 million in the current and prior-year quarters, respectively, which represents an increase of 7%, or 4% excluding impact of foreign exchange. Other Revenues** 72  110  -35%  -34%  Decline primarily due to lower revenue from third-party manufacturing arrangements. *Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Second-Quarter Expense and Related Information
The table below presents selected expense information. $ in millions GAAP Acquisition-
and
Divestiture-
Related Costs4 Restructuring
Costs (Income)
Loss From
Investments
in Equity
Securities Non-
GAAP3 Second Quarter 2026 Cost of sales $4,395  $1,067  $184  $-  $3,144  Selling, general and administrative 2,904  17  -  -  2,887  Research and development 9,741  6  (1)  -  9,736  Restructuring costs 151  -  151  -  -  Other (income) expense, net 99  -  -  (191)  290              Second Quarter 2025         Cost of sales $3,557  $576  $165  $-  $2,816  Selling, general and administrative 2,649  15  1  -  2,633  Research and development 4,048  3  53  -  3,992  Restructuring costs 560  -  560  -  -  Other (income) expense, net (7)  -  -  (61)  54  GAAP Expense, EPS and Related Information
Gross margin was 73.5% for the second quarter of 2026 compared with 77.5% for the second quarter of 2025. The decrease was primarily due to higher amortization of intangible assets and inventory write-downs. Selling, general and administrative (SG&A) expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches. Research and development (R&D) expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences (Blackstone). R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma. Other (income) expense, net, was $99 million of expense in the second quarter of 2026 compared with $7 million of income in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities. The income tax provision for the second quarter of 2026 was $654 million on a pretax loss of $683 million, resulting in an effective income tax rate of (95.9)%. This effective income tax rate includes a 108.9 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded. GAAP loss per share was $0.54 for the second quarter of 2026 compared with earnings per share of $1.76 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma. Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.1% for the second quarter of 2026 compared with 82.2% for the second quarter of 2025. The decrease was primarily due to higher inventory write-downs. Non-GAAP SG&A expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches. Non-GAAP R&D expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma. Non-GAAP other (income) expense, net, was $290 million of expense in the second quarter of 2026 compared with $54 million of expense in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense. The non-GAAP income tax provision for the second quarter of 2026 was $882 million on pretax income of $550 million, resulting in a non-GAAP effective income tax rate of 160.3%. This effective income tax rate includes a 146.2 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded. Non-GAAP loss per share was $0.13 for the second quarter of 2026 compared with earnings per share of $2.13 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma. A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows. Second Quarter $ in millions, except EPS amounts 2026  2025  EPS   GAAP EPS $(0.54)  $1.76  Difference 0.41  0.37  Non-GAAP EPS that excludes items listed below3 $(0.13)  $2.13        Net (Loss) Income   GAAP net (loss) income2 $(1,335)  $4,427  Difference 1,005  939  Non-GAAP net (loss) income that excludes items listed below2,3 $(330)  $5,366        Excluded Items:   Acquisition- and divestiture-related costs4 $1,090  $594  Restructuring costs 334  779  Income from investments in equity securities (191)  (61)  Increase to net loss / decrease to net income before taxes 1,233  1,312  Estimated income tax benefit5 (228)  (373)  Increase to net loss / decrease to net income $1,005  $939  Pipeline and Portfolio Highlights In the second quarter, the Company achieved key regulatory milestones across the portfolio while continuing to advance its broad and diverse pipeline. Oncology: U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma (ccRCC), based on Phase 3 LITESPARK-022 trial. Approvals represent first approved combination of a PD-1 and hypoxia-inducible factor-2 alpha inhibitor for these patients. In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer (MIBC), including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial; the expansion builds upon prior approval of this regimen for cisplatin ineligible patients based on Phase 3 KEYNOTE-905 trial. FDA approved KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of PD-L1 positive (Combined Positive Score [CPS] ≥10) advanced TNBC, based on Phase 3 KEYNOTE-D19/ASCENT-04 trial. FDA granted Breakthrough Therapy designation (BTD) for calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%). Announced that Phase 3 TroFuse-005 trial evaluating sac-TMT, an investigational anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. First Phase 3 results from the Company’s broad sac-TMT clinical development program, which includes 17 ongoing global Phase 3 trials across multiple tumor types. At the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, new research was presented across over 25 types of cancer, reinforcing long-term impact of KEYTRUDA and momentum in the Company’s rapidly advancing oncology pipeline, including: Five-year follow-up data from Phase 2b KEYNOTE-942 trial, in collaboration with Moderna, underscoring continued potential of intismeran autogene (mRNA-4157/V940) in combination with KEYTRUDA for patients with stage III/IV melanoma following complete resection. Data from Phase 3 OptiTROP-Lung05 trial, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in China, adding to ongoing research of novel treatment approaches for patients with NSCLC. Results from final analysis of KEYNOTE-522 evaluating KEYTRUDA in combination with chemotherapy, reporting a continued survival benefit for patients with high-risk early-stage TNBC. Vaccines and Infectious Diseases: In July, presented new data for daily and weekly options across HIV treatment and prevention pipeline at 26th International AIDS Conference (AIDS 2026). Hosted HIV investor event to highlight these data. In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. ISL/LEN has the potential to be the first approved oral, once-weekly HIV treatment. Presented first results from a Phase 2b study evaluating switch to investigational once-weekly oral islatravir and ulonivirine (ISL/ULO) in adults with virologically suppressed HIV-1. Received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. Cardiometabolic and Respiratory: In July, FDA approved LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise, to reduce LDL-C in adults with hypercholesterolemia, based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH. At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively. Immunology: Announced positive topline results from Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC). Initial topline results from primary analyses of two Phase 2 studies evaluating tulisokibart: In hidradenitis suppurativa (HS), the study met its primary and key secondary endpoints. Full results will be shared at an upcoming medical meeting. In systemic sclerosis-associated interstitial lung disease (SSc-ILD), the study did not meet its primary endpoint and will be discontinued. No new safety concerns were identified. Business Development: Completed acquisition of Terns for $6.8 billion. Added MK-4208, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor recently granted BTD by the FDA for the treatment of certain adults with Philadelphia chromosome-positive chronic myeloid leukemia. Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.* Oncology FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With ccRCC; Based on Results From Phase 3 LITESPARK-022 Trial FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial, Combined With Previous Approvals Based on Phase 3 KEYNOTE-905 Trial FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Trodelvy, as First-Line Treatment of PD-L1+ Advanced TNBC; Based on Results From Phase 3 KEYNOTE-D19/ASCENT-04 Trial European Commission Approved KEYTRUDA Plus Padcev as First PD-1 Inhibitor Plus ADC Regimen for Adults With Cisplatin-Ineligible Resectable MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial FDA Granted BTD for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients With Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC The Company Announced TroFuse-005 Trial Evaluating Sac-TMT Met Primary Endpoints of OS and PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer The Company and Moderna Presented 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at ASCO 2026 KEYTRUDA as Monotherapy Significantly Improved PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial The Company Highlighted New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO 2026 The Company Completed Acquisition of Terns Vaccines and
Infectious Diseases The Company, in Collaboration With Gilead, Announced That the Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir (ISL/LEN) Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy The Company Presented New Data on Daily, Weekly and Monthly Options Across its HIV Treatment and Prevention Pipeline at AIDS 2026 The Company Announced Initial Access Plans for Alimatravir (MK-8527), Its Investigational Once-Monthly Oral Pre-Exposure Prophylaxis in Phase 3 Development; Multi-Faceted Strategy Aims To Enable Rapid, Broad and Sustainable Access to Alimatravir, if Approved, in Low- And Middle-Income Countries The Company Announced New Agreement With AIDS Drug Assistance Program Crisis Task Force To Improve Access and Care for People Living With HIV FDA Approved an Additional Indication for CAPVAXIVE in Children and Adolescents Aged 2 Through 17 at Increased Risk for Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial Cardiometabolic and Respiratory FDA Approved LIPFENDRA, the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia; Based on Results From CORALreef Lipids and CORALreef HeFH Trials Immunology Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active UC Animal Health The Company’s Animal Health Business Completed Acquisition of TARGAN, Broadening Its Commercial Poultry Portfolio Through TARGAN’s Innovative High-Speed Biodevice Technology *References in the above news release titles have been modified for the purpose of this announcement. Upcoming Investor Event
The Company will hold an Oncology Investor Event to coincide with the European Society for Medical Oncology Congress 2026 on Monday, Oct. 26, 2026, at 6 p.m. CET / 1 p.m. EDT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Madrid, Spain, and will be accessible via live audio webcast at this weblink. Full-Year 2026 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.   Full Year 2026   Updated Prior Sales* $66.3 billion to $67.3 billion $65.8 billion to $67.0 billion Non-GAAP Gross margin3 Approximately 81% Approximately 82% Non-GAAP Operating expenses3** $42.0 billion to $42.7 billion $36.0 billion to $36.8 billion Non-GAAP Other (income) expense, net3 Approximately $1.4 billion expense Approximately $1.3 billion expense Non-GAAP Effective income tax rate3 35.0% to 36.0% 23.5% to 24.5% Non-GAAP EPS3*** $2.66 to $2.76 $5.04 to $5.16 Share count (assuming dilution) Approximately 2.48 billion Approximately 2.48 billion *The Company does not have any non-GAAP adjustments to sales. **Includes one-time R&D charges of $9.0 billion for the acquisition of Cidara Therapeutics, Inc. (Cidara) and $5.7 billion for the acquisition of Terns. Outlook does not assume any additional significant potential business development transactions. ***Includes one-time charges of $3.62 per share for the acquisition of Cidara and $2.31 per share for the acquisition of Terns. The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective income tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results. The Company is raising and narrowing the range for its full-year sales outlook and now anticipates full-year 2026 sales to be between $66.3 billion and $67.3 billion, including a positive impact from foreign exchange of approximately 1% at mid-July 2026 exchange rates. The Company now expects the full-year non-GAAP effective income tax rate to be between 35.0% and 36.0%, including the impact of the non-tax deductible one-time charges for the acquisitions of Cidara and Terns. The Company now expects full-year 2026 non-GAAP EPS to be between $2.66 and $2.76, including a positive impact from foreign exchange of approximately $0.15 per share at mid-July 2026 exchange rates. This range includes one-time charges of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara and $5.7 billion, or $2.31 per share, related to the acquisition of Terns. This range also includes costs of approximately $0.12 per share to finance the Terns acquisition and advance MK-4208. The charges related to Terns were not previously included in the outlook. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Aug. 4, at 9 a.m. EDT via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website. All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Our Company
At Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Appendix
Generic product names are provided below. Pharmaceutical
BRIDION (sugammadex)
CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)
ENFLONSIA (clesrovimab-cfor)
GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
JANUMET (sitagliptin and metformin HCl)
JANUVIA (sitagliptin)
KEYTRUDA (pembrolizumab)
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)
LAGEVRIO (molnupiravir)
Lenvima (lenvatinib)
LIPFENDRA (enlicitide)
Lynparza (olaparib)
M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)
OHTUVAYRE (ensifentrine)
PREVYMIS (letermovir)
PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
VARIVAX (Varicella Virus Vaccine Live)
VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk) Animal Health
BRAVECTO (fluralaner) _______________________________  1 Available in some markets as KEYTRUDA SC. 2 Net (loss) income attributable to the Company. 3 The Company is providing certain 2026 and 2025 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. 4 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions. 5 Includes the estimated income tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented. Amount in the second quarter of 2025 also includes a $146 million benefit primarily resulting from favorable audit reserve adjustments. MERCK & CO., INC., RAHWAY, N.J., USA CONSOLIDATED STATEMENT OF OPERATIONS - GAAP (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 1     GAAP % Change GAAP % Change   2Q26 2Q25 June YTD 2026 June YTD 2025     Sales $ 16,607   $ 15,806   5% $ 32,893   $ 31,335   5%     Costs, Expenses and Other     Cost of sales   4,395     3,557   24%   8,590     6,976   23% Selling, general and administrative   2,904     2,649   10%   5,604     5,202   8% Research and development   9,741     4,048   *   22,333     7,669   * Restructuring costs   151     560   -73%   346     629   -45% Other (income) expense, net   99     (7 ) *   237     (43 ) * (Loss) Income Before Taxes   (683 )   4,999   *   (4,217 )   10,902   * Income Tax Provision   654     571       1,363     1,388     Net (Loss) Income   (1,337 )   4,428   *   (5,580 )   9,514   * Less: Net (Loss) Income Attributable to Noncontrolling Interests   (2 )   1       (5 )   8     Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA $ (1,335 ) $ 4,427   * $ (5,575 ) $ 9,506   *     (Loss) Earnings per Common Share Assuming Dilution (1) $ (0.54 ) $ 1.76   * $ (2.26 ) $ 3.77   *   Average Shares Outstanding Assuming Dilution (1)   2,470     2,513     2,471     2,522   Tax Rate   -95.9 %   11.4 %   -32.3 %   12.7 %     * 100% or greater     (1) Because the Company recorded a net loss in both the second quarter and first six months of 2026, no potential dilutive common shares were used in the computations of loss per common share assuming dilution as the effects would have been anti-dilutive. MERCK & CO., INC., RAHWAY, N.J., USA THREE AND SIX MONTHS ENDED JUNE 30, 2026 GAAP TO NON-GAAP RECONCILIATION (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 2a   GAAP Acquisition- and
Divestiture-Related
Costs (1) Restructuring Costs (2) (Income) Loss from
Investments in
Equity Securities Adjustment
Subtotal Non-GAAP   Second Quarter Cost of sales $ 4,395   1,067   184   1,251   $ 3,144   Selling, general and administrative   2,904   17   17     2,887   Research and development   9,741   6   (1 ) 5     9,736   Restructuring costs   151   151   151     –   Other (income) expense, net   99   (191 ) (191 )   290   Loss Before Taxes   (683 ) (1,090 ) (334 ) 191   (1,233 )   550   Income Tax Provision (Benefit)   654   (219 ) (3) (50 ) (3) 41   (3) (228 )   882   Net Loss   (1,337 ) (871 ) (284 ) 150   (1,005 )   (332 ) Net Loss Attributable to Merck & Co., Inc., Rahway, N.J., USA   (1,335 ) (871 ) (284 ) 150   (1,005 )   (330 ) Loss per Common Share Assuming Dilution (4) $ (0.54 ) (0.35 ) (0.12 ) 0.06   (0.41 ) $ (0.13 )   Tax Rate   -95.9 %   160.3 %   June YTD Cost of sales $ 8,590   2,081   421   2,502   $ 6,088   Selling, general and administrative   5,604   49   49     5,555   Research and development   22,333   6   33   39     22,294   Restructuring costs   346   346   346     –   Other (income) expense, net   237   (371 ) (371 )   608   Loss Before Taxes   (4,217 ) (2,136 ) (800 ) 371   (2,565 )   (1,652 ) Income Tax Provision (Benefit)   1,363   (421 ) (3) (135 ) (3) 80   (3) (476 )   1,839   Net Loss   (5,580 ) (1,715 ) (665 ) 291   (2,089 )   (3,491 ) Net Loss Attributable to Merck & Co., Inc., Rahway, N.J., USA   (5,575 ) (1,715 ) (665 ) 291   (2,089 )   (3,486 ) Loss per Common Share Assuming Dilution (4) $ (2.26 ) (0.70 ) (0.27 ) 0.12   (0.85 ) $ (1.41 )   Tax Rate   -32.3 %   -111.3 %     Only the line items that are affected by non-GAAP adjustments are shown. The Company is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the Company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. (1) Amounts included in cost of sales reflect expenses for the amortization of intangible assets, as well as the recognition of fair value step-up of inventories related to the 2025 Verona Pharma plc acquisition. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. (2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairment charges associated with facilities to be closed or divested, as well as contractual termination costs, associated with activities under the Company's formal restructuring programs. (3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. (4) Because the Company recorded a net loss in both the second quarter and first six months of 2026, no potential dilutive common shares were used in the computations of loss per common share assuming dilution as the effects would have been anti-dilutive. MERCK & CO., INC., RAHWAY, N.J., USA FRANCHISE / KEY PRODUCT SALES (AMOUNTS IN MILLIONS) (UNAUDITED) Table 3   2026   2025   2Q   June YTD 1Q 2Q June YTD   1Q 2Q June YTD 3Q 4Q Full Year   Nom % Ex-Exch %   Nom % Ex-Exch % TOTAL SALES (1) $16,286 $16,607 $32,893 $15,529 $15,806 $31,335 $17,276 $16,400 $65,011 5 4 5 3 PHARMACEUTICAL 14,349 14,760 29,109 13,638 14,050 27,688 15,611 14,843 58,142 5 4 5 3 Oncology Keytruda 7,906 7,904 15,810 7,205 7,956 15,161 8,142 8,337 31,641 -1 -2 4 2 Keytruda Qlex 128 463 590 5 35 40 - - - - Alliance Revenue – Lynparza (2) 341 365 706 312 370 682 379 389 1,450 -1 -2 4 2 Alliance Revenue – Lenvima (2) 256 283 539 258 265 523 258 272 1,053 7 6 3 2 Welireg 199 271 470 137 162 300 196 220 716 67 67 57 56 Alliance Revenue – Reblozyl (3) 148 122 270 119 107 226 136 164 525 15 15 20 20 Vaccines (4) Gardasil/Gardasil 9 1,069 1,169 2,238 1,327 1,126 2,453 1,749 1,031 5,233 4 3 -9 -10 ProQuad/M-M-R II/Varivax 538 592 1,130 539 609 1,148 684 619 2,451 -3 -3 -2 -3 Vaxneuvance 202 148 350 230 229 459 226 140 825 -35 -36 -24 -26 RotaTeq 206 134 340 228 121 349 204 119 673 10 9 -3 -4 Capvaxive 142 184 325 107 129 236 244 279 759 42 40 38 36 Enflonsia 1 2 3 79 21 100 - - - - Cardiometabolic & Respiratory Winrevair 525 588 1,114 280 336 615 360 467 1,443 75 75 81 81 Ohtuvayre 131 204 335 178 178 - - - - Alliance Revenue - Adempas/Verquvo (5) 109 126 235 106 123 229 112 129 470 3 3 3 3 Adempas (6) 78 78 156 68 80 147 82 83 312 -2 -4 6 1 Infectious Diseases Bridion 472 497 969 441 461 902 439 499 1,841 8 8 7 7 Prevymis 272 295 568 208 228 436 266 275 978 29 28 30 27 Delstrigo 75 101 176 67 83 150 77 79 306 21 17 17 10 Zerbaxa 82 77 159 70 74 145 81 87 312 4 2 10 8 Isentress/Isentress HD 59 60 119 90 86 176 82 67 325 -30 -31 -32 -33 Dificid 34 22 56 83 96 179 43 25 247 -77 -77 -69 -69 Lagevrio 28 5 32 102 83 185 138 57 380 -95 -95 -82 -83 Diabetes Januvia 367 258 625 549 372 921 382 302 1,604 -31 -30 -32 -32 Janumet 207 171 378 247 251 498 243 199 940 -32 -33 -24 -25 Other Pharmaceutical (7) 774 641 1,416 865 703 1,568 1,004 770 3,340 -9 -9 -10 -11 ANIMAL HEALTH 1,791 1,775 3,566 1,588 1,646 3,234 1,615 1,505 6,354 8 5 10 6 Livestock 1,064 1,041 2,105 924 961 1,885 1,023 987 3,896 8 6 12 7 Companion Animal 727 734 1,461 664 685 1,349 592 518 2,458 7 5 8 4 Other Revenues (8) 146 72 218 303 110 413 50 52 515 -35 -34 -47 -6 Sum of quarterly amounts may not equal year-to-date amounts due to rounding. (1) Only select products are shown.           (2) Alliance Revenue represents the Company's share of profits, which are product sales net of cost of sales and commercialization costs.           (3) Alliance Revenue represents royalties. (4) Total Vaccines sales were $2,314 million and $2,361 million in the first and second quarter of 2026, respectively, and $2,607 million and $2,370 million in the first and second quarter of 2025, respectively. (5) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs. (6) Net product sales in the Company's marketing territories. (7) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million and $10 million in the first and second quarter of 2026, respectively, and $44 million and $43 million in the first and second quarter of 2025, respectively. (8) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of milestone payments for out-licensed products were $132 million and $0 million in the first and second quarter of 2026, respectively, and $95 million and $5 million in the first and second quarter of 2025, respectively.    View source version on businesswire.com: https://www.businesswire.com/news/home/20260804781126/en/ Media Contacts: Michael Levey
michael.levey@msd.com John Cummins
john.cummins2 @Edwin48 Steven Graziano
(732) 594-1583 Original: Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse Pipeline

Merck Announces Fourth-Quarter 2026 DividendJuly 29, 2026 11:04 AM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.85 per share of the company’s common stock for the fourth quarter of 2026. Payment will be made on October 7, 2026, to shareholders of record at the close of business on September 15, 2026. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260729562164/en/ Media Contacts: John Cummins
john.cummins2@merck.com Michael Levey
michael.levey@merck.com Investor Contacts: Peter Dannenbaum
(732) 594-1579 Steven Graziano
(732) 594-1583 Original: Merck Announces Fourth-Quarter 2026 Dividend

Merck Announces Initial Access Plans for Alimatravir, an Investigational Once-Monthly Oral HIV Pre-Exposure Prophylaxis in Phase 3 DevelopmentJuly 24, 2026 6:45 AM
Business Wire Multi-faceted strategy aims to enable rapid, broad and sustainable access to alimatravir (MK-8527), if approved, in low- and middle-income countries Voluntary licensing agreements cover 129 countries in regions which account for the substantial majority of new HIV diagnoses globally As Phase 3 trials continue, Merck is committed to advancing access plans, working in close collaboration with the HIV community and global health stakeholders Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced early components of a multi-faceted strategy to provide rapid, broad and sustainable access in low- and middle-income countries (LMICs) to alimatravir (MK-8527), an investigational, novel, once-monthly oral pill as pre-exposure prophylaxis (PrEP) for the prevention of HIV-1, following regulatory approval. Initial access plans as part of Merck’s broader strategy include establishing early generic licensing covering 129 LMICs; supporting targeted, regional manufacturing capabilities in Africa and Latin America; and investing early in product manufacturing to enable timely access and availability in regions of high unmet need. The first steps of this strategy are being announced in the lead up to the 26th International AIDS Conference in Rio de Janeiro, Brazil. Key Highlights: Planning early for rapid, broad and sustainable access in LMICs: By initiating a multi-faceted access strategy while Phase 3 trials are ongoing and before enrollment is complete, Merck aims to make alimatravir available in LMICs as broadly and as quickly as possible, if approved. Community-guided access strategy: Merck’s access plans have been shaped by years of engagement with the HIV community, advocates and global health stakeholders, and that collaboration will continue as Phase 3 trials progress. A potential new oral PrEP option: If approved, alimatravir would provide an important new option, with the potential to offer one month of protection from HIV-1 in one pill, predicted to be protective starting within one hour after dosing. Globally, 1.2 million people acquired HIV in 2025, approximately 3,300 each day. Today, multiple HIV prevention options are available, including daily oral PrEP, long-acting injectable PrEP, and other evidence-based prevention tools. Yet, according to the 2024 UNAIDS report, only 3.5 million people were using oral PrEP in 2023, demonstrating the urgent need to expand access and uptake to reach the global goal of 20 million people receiving PrEP by 2030. New access programs should enable rapid, broad and sustainable scale-up, and focus on the persistent barriers that may be limiting PrEP use, including stigma and affordability. “Scientific innovation only has impact when it reaches those who need it most,” said Robert M. Davis, chairman and chief executive officer, Merck. “Merck has a deep legacy in HIV and a longstanding commitment to public health. Recognizing the urgent, unmet needs in HIV prevention, we are acting early to enable rapid, broad and sustainable access to alimatravir, an investigational once-monthly oral PrEP option, in low- and middle-income countries. These important first steps reflect years of engagement with advocates and global health stakeholders. As Phase 3 trials progress, we remain committed to advancing our efforts in partnership with the HIV community to help maximize the public health impact of alimatravir, if approved.” Establishing early voluntary licensing agreements
Merck has signed seven non-exclusive voluntary licensing agreements* with generic manufacturers, including three in sub-Saharan Africa (Aspen Pharmacare Holdings, Ltd (Aspen), Quality Chemical Industries Limited (Qcil) and UCL Kenya) and four in India (Aurobindo, Cipla, Emcure and Viatris). The royalty-free agreements with these companies cover both the public and private sectors and will enable supply of generic alimatravir in 129 LMICs that account for a substantial majority of new HIV diagnoses globally. Entering into licensing agreements before Phase 3 trial enrollment is complete represents a first in HIV prevention. This early action should help stakeholders across the HIV response begin planning for ambitious scale-up. It will also facilitate the acceleration of developmental and regulatory activities by the licensed generic manufacturers to help them bring generic alimatravir that meets internationally recognized standards to market in licensed territories, if approved. “Merck's early and proactive efforts to enable quick access to its new PrEP option, if approved, are important to help protect the communities most affected by HIV,” said Mark Suzman, chief executive officer of the Gates Foundation, which aims to end or significantly reduce preventable infectious diseases, including HIV, in the next two decades. “We look forward to continuing to work with Merck and other partners who will help advance these plans and expand access to HIV prevention options.” Supporting targeted, regional manufacturing
Sustainable access for HIV prevention requires reliable supply chains, strong local partnerships and country ownership and prioritization. The voluntary licensing strategy for alimatravir is designed to help support sustainable access across Africa and other high-burden geographies by enabling regional manufacturing, strengthening supply resilience and supporting long-term availability following approval. Africa has the highest burden of HIV worldwide. With this announcement, for the first time in HIV, generic manufacturers in sub-Saharan Africa have been included in the initial voluntary licenses granted, alongside generic manufacturers in India, enabling planning for introduction and scale-up by local manufacturers. “People across Africa need more options to prevent HIV. A once-monthly pill could provide a different choice for people in how to protect themselves, subject to successful trials and regulatory approval,” said Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention. “We welcome this decision to engage African manufacturers early. Africa must continue to expand its role across the health innovation value chain, from supporting research ecosystems and clinical trial capacity to manufacturing and access. This is how we strengthen health sovereignty and bring new HIV prevention options closer to our people.” HIV incidence remains a pressing public health challenge in Latin America, and specifically in Brazil, where approximately 55,000 people acquired HIV in 2024. In recognition of this significant unmet need, Merck is in active discussions with organizations, including Fiocruz, with a goal to enable rapid availability and broad supply of alimatravir in the region. Investing early in product manufacturing
To reduce the time between potential regulatory approval of alimatravir and its availability in LMICs, Merck is investing early in its product manufacturing capacity as Phase 3 trials continue. These efforts are intended to help ensure that sufficient product supply is made available, if approved, in areas of high unmet need following the anticipated U.S. approval to enable early program implementation and ambitious scale-up. Merck expects to provide initial supply and continue supplying product as needed while licensed generic manufacturers complete development, obtain the necessary regulatory approvals and prepare to provide supply in the licensed territories. The goal is to help avoid delays in access by providing an initial supply pathway until generic manufacturing capacity is established and brought online. These actions represent important early steps to help support the future availability and supply of alimatravir in countries with a high burden of HIV, subject to applicable regulatory approvals and requirements. Merck is committed to continuing to advance its access plans, working in close collaboration with communities and global health stakeholders, as Phase 3 trials continue. About alimatravir (MK-8527)
Alimatravir (MK-8527) is being evaluated as a potential once-monthly oral prevention option for HIV-1. Alimatravir inhibits reverse transcriptase through multiple mechanisms, including: inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Alimatravir is currently being evaluated in two ongoing Phase 3 clinical trials. With financial support from the Gates Foundation, the Phase 3 EXPrESSIVE-10 trial (MK-8527-010, NCT07071623) is evaluating the safety and efficacy of alimatravir in adolescent girls and young women in Kenya, South Africa and Uganda. The Phase 3 EXPrESSIVE-11 trial (MK-8527-011, NCT07044297) is evaluating the safety and efficacy of alimatravir among people with greater likelihood of HIV-1 exposure in 16 countries. Both trials are now enrolling. The initiation of the Phase 3 clinical trial program was supported by results of a double-blind, multicenter, Phase 2 trial (MK-8527-007, NCT06045507) examining the safety and pharmacokinetics of alimatravir. The study enrolled 350 participants, 18–65 years of age, with low likelihood of HIV-1 exposure, who were randomized 2:2:2:1 to receive alimatravir (3, 6 or 12 mg) or placebo once monthly for six months. In the trial, the rates of adverse events were similar among those in the alimatravir arms and those in the placebo arm, and no clinically meaningful changes were seen in laboratory tests, including total lymphocyte and CD4 T-cell counts. The pharmacokinetics of alimatravir and alimatravir-triphosphate, the active form of alimatravir, support the continued development of alimatravir as an oral, once-monthly option for PrEP. Merck is committed to ensuring that the people who are participating in the EXPrESSIVE Phase 3 trials have access to alimatravir after the trials conclude, pending regulatory approval. Merck’s Commitment to HIV
For more than 40 years, Merck has been committed to research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options for both HIV treatment and prevention. We’re inspired by the lived experiences of the HIV community as we advance research with real life in mind. Our work focuses on potentially transformative innovations, collaborations with others in the global HIV community and access initiatives to help end the HIV epidemic. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here. About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). *Template before negotiations and execution with the generic manufacturers. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723155636/en/ Media Contacts: Melissa Moody
(215) 407-3536 Kristen Drake
(908) 334-4688 Investor Contacts: Ayn Wisler
(732) 594-0482 Peter Dannenbaum
(732) 594-1579 Original: Merck Announces Initial Access Plans for Alimatravir, an Investigational Once-Monthly Oral HIV Pre-Exposure Prophylaxis in Phase 3 Development

Merck’s LIPFENDRA® (enlicitide) is the First and Only Once-Daily Oral PCSK9 Inhibitor Approved by the U.S. FDA to Reduce LDL-C in Adults with HypercholesterolemiaJuly 16, 2026 6:45 AM
Business Wire At week 24 in the CORALreef Lipids and CORALreef HeFH trials, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively LIPFENDRA is a novel macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved LIPFENDRA® (enlicitide) tablets 20 mg as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). LIPFENDRA is a novel macrocyclic peptide and is the first FDA-approved oral PCSK9 inhibitor shown to lower LDL-C, also known as bad cholesterol. “By harnessing the innovative science of PCSK9 inhibitors and novel macrocyclic peptide technology, LIPFENDRA was designed to significantly lower LDL-C in the form of a convenient once-daily pill,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “This is a pivotal moment as we bring the first U.S. FDA-approved oral PCSK9 inhibitor to adults with high LDL-C, offering patients an important new option. We’re proud of our work with regulators on this rigorous and efficient review process.” The approval is based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH. In CORALreef Lipids, LIPFENDRA reduced LDL-C by 56% compared to placebo at week 24. A 60% decrease from baseline in LDL-C was observed with LIPFENDRA when biologically impossible baseline LDL-C values were removed according to revised data handling rules (post-hoc). In CORALreef HeFH, LIPFENDRA reduced LDL-C by 59% at week 24 compared to placebo. Results from these Phase 3 trials showed treatment with LIPFENDRA resulted in reductions across other atherogenic lipoproteins associated with atherosclerotic cardiovascular disease (ASCVD) risk including non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB). The safety profile of LIPFENDRA in CORALreef Lipids was similar to placebo. In CORALreef HeFH, the most common adverse reactions in adults with HeFH treated with LIPFENDRA that occurred at higher frequencies compared to placebo were diarrhea (LIPFENDRA 7%, placebo 2%) and dizziness (LIPFENDRA 9%, placebo 4%). In both trials, similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. For additional information on results from the CORALreef trials, see “Clinical data supporting FDA approval” below. “High LDL-C is a major risk factor for atherosclerotic cardiovascular disease, which is the leading cause of death globally,” said Dr. Ann Marie Navar, a lead author of the CORALreef Lipids study and associate professor of medicine in the Division of Cardiology at UT Southwestern Medical Center. “In two Phase 3 trials, LIPFENDRA led to impressive reductions in LDL-C. Now, for the first time, patients have an oral PCSK9 inhibitor for LDL lowering.” An ongoing clinical trial is studying the effect of LIPFENDRA on cardiovascular morbidity and mortality. It is not yet known if LIPFENDRA can reduce the risk of cardiovascular morbidity and mortality. “One of the greatest opportunities to help manage the risk of ASCVD lies in the timely identification and appropriate treatment of risk factors, such as LDL-C,” said Katherine Wilemon, CEO of the Family Heart Foundation. “We are encouraged by the approval of a new oral PCSK9 inhibitor option for adults who need additional LDL-C lowering.” Clinical data supporting FDA approval LIPFENDRA was approved based on results from two pivotal Phase 3 trials from the CORALreef clinical trial program: At week 24, in the CORALreef Lipids trial, treatment with LIPFENDRA resulted in: A statistically significant and clinically meaningful reduction in LDL-C of 56% compared to placebo at week 24 (95% CI: -61, -51; p

KEYTRUDA® (pembrolizumab) as Monotherapy Significantly Improved Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient (dMMR) Tumors Compared to ChemotherapyJuly 15, 2026 6:45 AM
Business Wire KEYTRUDA is the first and only PD-1 inhibitor to improve PFS compared to platinum doublet chemotherapy for these patients in a Phase 3 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Phase 3 KEYNOTE-C93 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy. KEYTRUDA is the first and only PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to platinum doublet chemotherapy for these patients in a Phase 3 trial. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for KEYTRUDA; however, these OS data were not mature at the time of this analysis. The trial is ongoing, and OS for the full study population will be evaluated at a future analysis. This analysis also showed a clinically meaningful overall response rate (ORR), as well as complete response rate (CRR) and duration of response (DOR) for KEYTRUDA. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities. “This is the first Phase 3 trial of a PD-1 inhibitor to show improved PFS compared to platinum doublet chemotherapy when given as monotherapy in the frontline setting for these patients, potentially providing a chemo-free option,” said Dr. Brian Slomovitz, director of Gynecologic Oncology and deputy director of the Braman Comprehensive Cancer Center at Mount Sinai Medical Center in Miami Beach, Florida, and the study’s overall principal investigator. “These findings build upon the well-established role of KEYTRUDA in endometrial cancer, one of the few cancers with rising incidence rates,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are committed to helping women facing this disease by advancing potential treatment options. We thank the patients and investigators for their important contributions to this study and look forward to sharing these results with the medical community.” In the U.S., KEYTRUDA is the only anti-PD-1 therapy with three approved indications for patients with certain types of endometrial cancer. KEYTRUDA is indicated: in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma; in combination with LENVIMA® (lenvatinib), in collaboration with Eisai, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR), as determined by an FDA-authorized test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; and as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Merck has a comprehensive clinical development program evaluating KEYTRUDA (both as monotherapy and in combination with chemotherapy) and sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, in endometrial cancer. As previously announced, TroFuse-005 (NCT06132958) met its primary endpoints of PFS and OS, as well as its key secondary endpoint of ORR in patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy. In addition, TroFuse-033 (NCT06952504) is enrolling patients with pMMR endometrial cancer to evaluate sac-TMT in an earlier treatment setting of first-line maintenance. The KEYNOTE-B21 trial (NCT04634877) remains ongoing for analysis in the dMMR subgroup. About KEYNOTE-C93 KEYNOTE-C93 is a randomized, open-label Phase 3 trial (NCT05173987) evaluating KEYTRUDA monotherapy versus carboplatin plus paclitaxel in patients with dMMR advanced or recurrent endometrial cancer who have not previously been treated with prior systemic chemotherapy. The trial enrolled 299 patients who were randomized to receive either: KEYTRUDA (400 mg) intravenously every six weeks for up to 18 cycles, or; Combination of paclitaxel (175 mg/m2) and carboplatin (AUC 5 or 6) every three weeks for six cycles. The trial’s dual primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS. A key secondary endpoint of the study is ORR. About endometrial cancer Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. Endometrial cancer is one of the few cancers with increasing mortality. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall. About Merck’s research in women’s cancers Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecologic cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to provide options to patients facing these devastating diseases. With more than 30 clinical trials in nearly 20,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Through our portfolio and pipeline, Merck is working to address the impact of women’s cancers on patients, their families and communities globally. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab) Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting are not candidates for curative surgery or radiation. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. See additional selected indications in the U.S. for KEYTRUDA after the Selected Safety Information. Selected Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC)July 10, 2026 2:10 PM
Business Wire First and only PD-1 inhibitor plus antibody-drug conjugate regimens approved for patients with MIBC regardless of cisplatin eligibility Approvals based on Phase 3 KEYNOTE-B15 trial, combined with previous approvals based on Phase 3 KEYNOTE-905 trial, bring forward new options for these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). These approvals represent the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens approved for adults with MIBC regardless of cisplatin eligibility. These approvals are based on data from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas and enrolled 808 patients. They also expand the previously approved indication based on the Phase 3 KEYNOTE-905 trial (also known as EV-303) for KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, in the U.S. as treatment before and after surgery for adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. In KEYNOTE-B15, KEYTRUDA plus Padcev, given before and after surgery, demonstrated a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events (defined as disease progression, recurrence or death) by 47% (HR=0.53 [95% CI, 0.41-0.70]; p

Merck to Hold Second-Quarter 2026 Sales and Earnings Conference Call Aug. 4July 1, 2026 6:45 AM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its second-quarter 2026 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Tuesday, Aug. 4. During the call, company executives will provide an overview of Merck’s performance for the quarter. Investors, journalists and the general public may access a live audio webcast of the call via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available at www.merck.com. All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260701030641/en/ Media Contacts: John Cummins
john.cummins2@merck.com Michael Levey
michael.levey@merck.com Investor Contacts: Peter Dannenbaum
(732) 594-1579 Steven Graziano
(732) 594-1583 Original: Merck to Hold Second-Quarter 2026 Sales and Earnings Conference Call Aug. 4

Merck Announces New Agreement with ADAP Crisis Task Force to Improve Access and Care for People Living with HIVJune 29, 2026 6:45 AM
Business Wire Agreement will help state ADAP programs provide access to IDVYNSO™ (doravirine/islatravir) for eligible individuals Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced an agreement with the ADAP Crisis Task Force (ACTF) to help state AIDS Drug Assistance Programs (ADAPs) provide access to the company’s new once-daily HIV treatment, IDVYNSO™ (doravirine/islatravir). In 2024, state ADAPs supported more than 250,000 people with HIV in the United States. IDVYNSO was approved by the U.S. Food and Drug Administration (FDA) in April 2026 as a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. “ADAP programs play a critical role in supporting access to treatment for people living with HIV who are uninsured or underserved,” said Tim Horn, Director, Medication Access, National Alliance of State and Territorial AIDS Directors (NASTAD). “We appreciate Merck’s continued engagement and its willingness to work collaboratively to help address the critical access challenges facing state ADAP programs.” “Merck is pleased to have reached this agreement with the ADAP Crisis Task Force to expand access to IDVYNSO for eligible people with HIV,” said Conrod Kelly, U.S. HIV business unit head, Merck. “This agreement reflects our long-standing commitment to working with the ACTF, state ADAPs and the HIV community to strengthen access and help address persistent gaps in care.” For individuals with questions about coverage and affordability, the Merck Access Program may be able to provide information about insurance benefits, estimated out-of-pocket costs and co-pay assistance options for eligible patients. The Merck Access Program for IDVYNSO Merck offers support to individuals who are prescribed IDVYNSO, including information about patient insurance coverage and out-of-pocket costs, co-pay assistance for eligible, commercially insured individuals, and how individuals may access IDVYNSO through The Merck Access Program. For additional information, healthcare providers and individuals can call 1-877-709-4455 or visit https://www.merckaccessprogram-idvynso.com/. About IDVYNSO IDVYNSO is a fixed-dose combination of two medicines, doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms including: inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Selected Safety Information for IDVYNSO Contraindications IDVYNSO is contraindicated when co-administered with: drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO. lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO. (See Drug Interactions) Warnings and Precautions Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during postmarketing experience with doravirine-containing regimens. In addition, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) was reported with IDVYNSO in a clinical trial. Discontinue IDVYNSO, and other medications associated with these reactions, immediately if a painful rash with mucosal involvement, a progressive severe rash, or a rash with constitutional symptoms, eosinophilia, lymphadenopathy, or other organ involvement develops. Close clinical monitoring, and appropriate therapy should be initiated. The concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of IDVYNSO and possible development of resistance or possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO. Consider the potential for drug interactions prior to and during IDVYNSO therapy, review concomitant medications during IDVYNSO therapy, and monitor for adverse reactions. (See Drug Interactions) Adverse Reactions The most common adverse reactions (incidence ≥ 2%, all grades in any treatment group) reported in virologically suppressed participants in the IDVYNSO treatment groups in Trials 051 and 052, respectively, were: diarrhea (3% and 1%), dizziness (2% and 1%), fatigue (2% and 1%), abdominal distension (2% and 1%), headache (2% and 1%) and weight increased (2% and

Tech Rally and PCE Inflation Relief Lift Wall Street; Nasdaq Futures Surge as Micron Lead Market RallyJune 25, 2026 9:14 AM
IH Market News Dow Jones, S&P 500 and Nasdaq Futures are trading sharply higher this Thursday, fueled by a massive rally in the tech sector and investor relief over official inflation data. Pre-market optimism gained traction after corporate earnings crushed Wall Street estimates, while the macroeconomic landscape offered signs of monetary stability and cooling commodity prices. During pre-market trading, Nasdaq 100 futures surged an impressive 2.3%, leading gains in New York. S&P 500 futures rose 0.8%, while the Dow Jones posted a more modest advance, climbing 143 points (0.3%). In-Line PCE Brings Monetary Relief The day’s primary economic indicator, May’s Personal Consumption Expenditures (PCE) price index—the Federal Reserve’s preferred inflation metric—rose 0.4% for the month, coming in slightly below the 0.5% ceiling projected by economists. Over the past 12 months, the PCE recorded a 4.1% increase. Core PCE, which excludes volatile food and energy prices, rose 0.3% month-over-month and 3.4% year-over-year, landing exactly in line with consensus projections. Although underlying inflation remains above the Fed’s 2% target—justifying keeping interest rates at their current range of 3.50% to 3.75% per year—the market breathed a sigh of relief upon seeing that recent geopolitical shocks have not triggered an uncontrolled inflationary spiral. The 10-year Treasury yield ticked slightly higher by 1 basis point to 4.414%. Oil Erases War Gains, Plummeting Over 1% In the commodities market, the tone was one of sharp decompression. Brent crude futures for August delivery fell 1.4%, trading at $72.68 per barrel, erasing the risk premiums accumulated since the onset of hostilities in the Middle East. West Texas Intermediate (WTI) followed the same downward trend, dropping 1.4% to $69.35. The significant decline comes after the United States and Iran brokered a deal to reopen the Strait of Hormuz, releasing more than 20 oil tankers carrying approximately 35 million barrels of crude oil that had been held in the Persian Gulf for over three months. Citi analysts project that, as flows normalize, Brent should fall into the $60 to $65 range in the coming months. However, Iran’s Islamic Revolutionary Guard Corps Navy issued a warning that traffic will only be tolerated along routes strictly designated by Tehran, keeping geopolitical risks firmly on the radar. Top Corporate Moves on Wall Street Top Gainers Micron Technology (NASDAQ:MU): Shares of the chipmaker skyrocketed nearly 18% after reporting adjusted earnings of $25.11 per share (versus $20.78 expected) and seeing its annualized revenue quadruple to $41.46 billion. The company recorded a historic gross margin of 84.9%, outperforming giants like Meta and Nvidia, and is on track to open at an all-time high. Qualcomm (NASDAQ:QCOM): Surged 9.8% on the back of semiconductor optimism and after nearly doubling its 2029 revenue projection for non-smartphone segments, targeting $40 billion. Memory and Chip Sector: Driven by these results, Western Digital and SanDisk jumped more than 13% and 15%, respectively. Lam Research rose over 7%. Bio-Techne (NASDAQ:TECH): Shares surged 19.3% following confirmation of its acquisition by pharmaceutical giant Merck (NYSE:MRK) for $73 per share. Wendy’s (NASDAQ:WEN): Rose more than 11%, compounding a roughly 32% gain for the week, driven by strong appetite from retail investors. Top Losers: Darden Restaurants (NYSE:DRI): Fell over 3% after presenting a mixed fiscal fourth-quarter report and issuing full-year sales and earnings guidance below FactSet estimates. Amazon (NASDAQ:AMZN): Dipped slightly by 0.5% in pre-market trading. Despite announcing an additional $13 billion mega-investment in artificial intelligence and cloud infrastructure (AWS) in India through 2030, initial investor reaction was cautious regarding the scale of the capital expenditures. Corporate & Finance: JPMorgan Chase (NYSE:JPM): Shares rose 0.2% after the bank named Doug Petno and Troy Rohrbaugh as new co-presidents and heads of the financial institution’s largest divisions. The announcement is part of Jamie Dimon’s succession planning and marks the retirement of executive Marianne Lake. The post Tech Rally and PCE Inflation Relief Lift Wall Street; Nasdaq Futures Surge as Micron Lead Market Rally appeared first on US Editors. Original: Tech Rally and PCE Inflation Relief Lift Wall Street; Nasdaq Futures Surge as Micron Lead Market Rally

FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy® (sacituzumab govitecan-hziy) as First-Line Treatment of PD-L1+ (CPS ≥10) Advanced Triple-Negative Breast Cancer (TNBC)June 25, 2026 6:45 AM
Business Wire First approval of PD-1 inhibitors in combination with a Trop-2-directed antibody-drug conjugate (ADC) in advanced TNBC, marking a potentially practice-changing treatment option Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test. These approvals represent the first PD-1 inhibitors plus Trop-2-directed ADC regimen in advanced TNBC. These approvals are based on data from the Phase 3 KEYNOTE-D19/ASCENT-04 trial demonstrating that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.51-0.84]; p=0.0009) versus KEYTRUDA plus chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin) for the first-line treatment of adult patients with PD-L1+ (CPS ≥10) unresectable locally advanced or metastatic TNBC. KEYTRUDA plus Trodelvy resulted in a median progression-free survival (PFS) of 11.2 months [95% CI, 9.3-16.7] versus 7.8 months [95% CI, 7.3-9.3] with KEYTRUDA plus chemotherapy. The objective response rate (ORR) was higher with KEYTRUDA plus Trodelvy (61% [95% CI, 55-68]) than with KEYTRUDA plus chemotherapy (55% [95% CI, 48-62]), and complete responses occurred in 12% and 8% of patients, respectively. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy and safety profiles of KEYTRUDA QLEX and KEYTRUDA. “For people living with metastatic triple-negative breast cancer, the first treatment choice can be pivotal, as many patients may not have the opportunity to receive subsequent therapies,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and a principal investigator of Merck’s KEYNOTE-D19 and Gilead’s ASCENT-04 study. “These approvals are heartening news for patients and the clinical community, and I believe offer practice-changing first-line treatment options.” KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA and KEYTRUDA QLEX are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions in any or multiple organs, which can occur during or after treatment, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection; severe and life-threatening infusion or injection-related reactions; fatal and other serious complications in patients who receive allogeneic hematopoietic stem cell transplantation before or after beginning treatment; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when KEYTRUDA or KEYTRUDA QLEX is added to a thalidomide analogue plus dexamethasone, which is not recommended outside of controlled trials. Immune-mediated adverse reactions listed here may not include all such possible severe or fatal reactions. For more information, see “Selected Important Safety Information” below. “Patients with PD-L1+ unresectable locally advanced or metastatic TNBC have limited treatment options in the first-line setting, as this aggressive disease often advances quickly,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We now have new first-line treatment options that combine, for the first time, a PD-1 inhibitor with a Trop-2-directed ADC, and significantly reduce disease progression or death compared to KEYTRUDA plus chemotherapy. Today’s approvals of KEYTRUDA and KEYTRUDA QLEX each in combination with Trodelvy represent a meaningful milestone for those living with advanced TNBC.” Pembrolizumab (KEYTRUDA®) in combination with sacituzumab govitecan-hziy (Trodelvy®) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer as a category 1 preferred first-line treatment option for certain patients with recurrent unresectable (local or regional) or stage IV (M1) triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10).* “For appropriate patients with metastatic TNBC, a new first-line treatment option offers optimism to a community with historically few choices,” said Ricki Fairley, co-founder and CEO of TOUCH, The Black Breast Cancer Alliance. “TNBC disproportionately affects younger women – many in the prime of their lives – and often leads to poorer outcomes. Because so many patients may never receive subsequent lines of therapy, the ability to start with options like Trodelvy with or without KEYTRUDA or KEYTRUDA QLEX is critical. We have sought additional alternatives to chemotherapy-containing regimens in the first-line metastatic setting since TNBC was classified as a disease more than 20 years ago. As such, these approvals represent meaningful progress for the families impacted by this disease.” The median duration of exposure to KEYTRUDA was 8.5 months (range 1 day to 26.8 months). Fatal adverse reactions occurred in 3.2% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy, including death due to unknown cause (0.9%), and completed suicide, neutropenic sepsis, sepsis, pneumonia and pulmonary embolism (0.5% each). Serious adverse reactions occurred in 38% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy. Serious adverse reactions in ≥2% of patients were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), fatigue and pneumonia (2.3% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 9% of patients. The adverse reactions which resulted in permanent discontinuation of KEYTRUDA most commonly (≥1%) were pneumonitis and rash (1.4% each). Dosage interruptions of KEYTRUDA due to adverse reactions occurred in 67% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included neutropenia (36%), diarrhea (7%), upper respiratory tract infection (4.5%), anemia (4.1%), fatigue (4.1%), increased alanine aminotransferase (ALT) (3.2%), cough (2.7%), leukopenia (2.7%), nausea (2.7%), pyrexia (2.7%), rash (2.7%), vomiting (2.7%) and COVID-19 (2.3%). The most common (≥25%) adverse reactions, including laboratory abnormalities, occurring in patients treated with KEYTRUDA in combination with sacituzumab govitecan-hziy were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased glucose (50% each), increased ALT (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each) and decreased albumin (25%). *According to the NCCN Guidelines (Version 4.2026), category 1 is based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate. Preferred intervention refers to interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability. 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. About KEYNOTE-D19/ASCENT-04 KEYNOTE-D19/ASCENT-04 (ClinicalTrials.gov, NCT05382286) is a Phase 3 multicenter, open-label, randomized, active-controlled trial evaluating KEYTRUDA in combination with sacituzumab govitecan-hziy in patients with unresectable locally advanced or metastatic TNBC, who had not been previously treated with systemic therapy for advanced disease and whose tumors expressed PD-L1 (CPS ≥10) according to the PD-L1 IHC 22C3 pharmDx assay. The primary efficacy endpoint was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary efficacy endpoints included overall survival (OS) and objective response rate (ORR) as assessed by BICR using RECIST v1.1. Safety also was evaluated. The study enrolled 443 patients who were randomized 1:1 to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each 21-day cycle) plus sacituzumab govitecan-hziy (10 mg/kg IV on Days 1 and 8 of each 21-day cycle) (n=221) or KEYTRUDA (200 mg IV on Day 1 of each 21-day cycle) plus chemotherapy (n=222). The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Assessment of tumor status was performed every 8 weeks for the first 18 months, and every 12 weeks thereafter. Treatment beyond BICR-verified disease progression per RECIST 1.1 was permitted if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Crossover to sacituzumab govitecan-hziy monotherapy was offered following disease progression and study treatment discontinuation. About triple-negative breast cancer (TNBC) Triple-negative breast cancer is an aggressive type of breast cancer; it has the highest risk of recurrence within the first five years after treatment and is associated with worse outcomes compared to other forms of breast cancer. Approximately 10-15% of patients with breast cancer are diagnosed with TNBC. While some breast cancers may test positive for estrogen receptors (ER), progesterone receptors (PR) or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for ER and PR, and does not overexpress HER2. Triple-negative breast cancer tends to be more common in people who are younger than age 40, who are Black or who have certain gene mutations. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). KEYTRUDA QLEX must be administered by a healthcare provider. Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Triple-Negative Breast Cancer KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then each continued as a single agent as adjuvant treatment after surgery. KEYTRUDA and KEYTRUDA QLEX, each in combination with sacituzumab govitecan-hziy, are indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. See additional selected indications for KEYTRUDA and KEYTRUDA QLEX in the U.S. after the Selected Safety Information. Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX Contraindications KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Next-Generation DNA Repair Inhibitors Could Capture Billions in Emerging MarketJune 24, 2026 9:00 AM
InvestorsHub NewsWireNext-Generation DNA Repair Inhibitors Could Capture Billions in Emerging MarketBioMedWire Editorial Coverage: Oncology research is moving through one of its most active stretches in years. DNA Damage Response ("DDR") inhibitors, a category of drugs that work by blocking cancer cells' capacity to fix their own damaged DNA, are growing well beyond the poly ADP ribose polymerase ("PARP") inhibitor that first defined the category. DDR-inhibiting therapies generated an estimated $7 billion-plus in worldwide sales in 2025, and the wider oncology, diagnostics and precision medicine markets are expected to approach about $750 billion by 2030. A fresh wave of inhibitor classes is now taking shape as the next major opportunity. Standing at the leading edge of this shift is Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Profile), a Canadian clinical-stage oncology company developing ONC010(TM), a nanoparticle-encapsulated PNKP inhibitor designed to target a DNA repair enzyme that participates in several distinct repair pathways. As the industry works toward the next generation of synthetic lethality assets, Onco-Innovations occupies a distinctive niche as it builds out its position within the biopharmaceutical and biotechnology space, alongside other established companies such as Merck & Co. Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), GSK plc (NYSE: GSK) and Gilead Sciences Inc. (NASDAQ: GILD), all of which are focused on developing therapies for serious illnesses, including cancer.PARP inhibitors reshaped oncology when they first reached patients some 10 years ago, but they represent just one entry point into a much larger and more intricate biological network.Onco-Technologies owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies.The company's preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.Onco-Innovations holds global rights across three separate layers of protection, with each layer reinforcing the others.Click here to view the custom infographic of the Onco-Innovations editorial.DNA Repair Science Expands Past the PARP EraPARP inhibitors reshaped oncology when they first reached patients some 10 years ago. They put into practice a concept known as synthetic lethality, in which cancers carrying particular DNA repair defects could be selectively destroyed by disabling a secondary repair pathway. The effect was striking in BRCA-mutated cancers, and the drug class has since grown into a market worth billions of dollars. Yet PARP inhibitors represent just one entry point into a much larger and more intricate biological network.The DNA Damage Response system involves dozens of proteins and pathways that cancer cells depend on to withstand chemotherapy, radiation and other forms of cellular stress. Researchers have spent years systematically charting this network in search of new drug targets. A field once confined to academic circles is now attracting serious investment and clinical interest. Artios Pharma, for instance, closed a $115 million Series D financing round late last year to advance mid-stage studies of experimental cancer drugs targeting DNA repair mechanisms beyond PARP, one of the strongest signals yet that this segment has matured into an investable category.The clinical pipeline backs up that narrative. Last month, Artios dosed its first patient in a randomized phase 2 trial of ART6043, a DNA polymerase theta inhibitor, in patients with gBRCA-mutated, HER2-negative breast cancer, advancing a non-PARP DDR target into mid-stage, biomarker-guided development. Also last month, MD Anderson released phase 1 proof-of-concept results for RO7589831, a Werner helicase inhibitor, in cancers exhibiting high microsatellite instability. These are not minor announcements; they demonstrate that novel DDR mechanisms can produce real clinical responses in actual patients.Interest from potential partners in DDR assets has remained resilient even amid broader market turbulence. Last year, Repare Therapeutics out-licensed lunresertib to Debiopharm in a deal worth $10 million upfront, plus up to $257 million tied to milestones. Debiopharm went on to secure U.S. Food and Drug Administration ("FDA") Fast Track designation for a lunresertib combination in April 2026, converting a licensing arrangement into a formal regulatory achievement. The takeaway for investors appears straightforward: Biomarker-defined DDR assets backed by a credible scientific mechanism can still attract partners and earn regulatory recognition, even when funding conditions remain cautious.Polynucleotide Kinase Phosphatase, or PNKP, is a DNA repair enzyme that functions across numerous repair pathways, addressing both single-strand and double-strand break repair. This broader scope gives PNKP inhibitors a potentially wider therapeutic reach than PARP inhibitors, which act primarily on single-strand break repair. Inhibiting PNKP has already shown preclinical activity in colorectal, lung, breast, prostate, ovarian and blood cancers. With worldwide PARP inhibitor revenue forecast to total roughly $12 billion by 2030, PNKP inhibitors are surfacing as a significant drug class positioned to capture share within the expanding DNA Damage Response segment. Onco-Innovations has established itself as the recognized leader for this novel DDR target.Holding First-Mover Ground in Wide-Open CategoryMost competitive space in oncology drug development becomes crowded quickly. PARP inhibitors, PD-1 checkpoint drugs and CDK4/6 inhibitors each drew dozens of rivals once their commercial promise became evident. PNKP inhibitors stand apart from that pattern. The target has been described in academic literature for years, yet the drug-development community has been slow to act on it. That hesitancy created an opening, and Onco-Innovations has moved directly into it.The company owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies. This encompasses the core inhibitor compounds, the nanoparticle delivery science needed to carry those compounds effectively to tumors, and the synthetic lethality applications that define how the therapy is meant to function. Holding rights across molecular design, delivery mechanism and therapeutic application simultaneously is uncommon at this stage of oncology development.The competitive value of this position becomes clearer with added information. Once a new DDR target draws widespread industry attention, patent landscapes become congested, valuations climb and the window for first movers closes. Onco-Innovations entered the PNKP space while that window was still open. The company's patents cover the PNKP inhibitor technology as well as the ONC010 program, extending protection across the small molecule inhibitors themselves, the delivery system and the clinical applications, which together form a wide and durable competitive barrier.The broader DDR market supplies the commercial backdrop. Per the company, DDR-inhibiting products surpassed $7 billion in global sales last year. The global oncology market overall is forecast to approach $500 billion by 2032, representing growth of 131% across a 10-year span. Within that landscape, PNKP inhibitors occupy a category with no approved competitor and no entrenched incumbent. Rather than fighting for share in an already mature market, the company is effectively building the market itself.Laboratory Evidence Lays Groundwork for Clinical TrialsAmong the central risk factors in early-stage oncology investing is the distance separating laboratory findings from clinical reality. Onco-Innovations has worked methodically to close that gap. The company's preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.The standout finding from animal studies relates to survival outcomes in colorectal cancer. Published preclinical data show that the company's novel nanoparticle formulation, ONC010, extended median survival to 60 days in mice with PTEN-deficient colorectal cancer, compared with 23 days in untreated animals, more than double the survival duration. The same body of research showed substantial tumor growth reduction relative to placebo, paired with a favorable toxicity profile.The lack of observed toxicity in animal models carries particular weight. DDR inhibitors  have generally run into off-target effects that constrain their clinical usefulness. Onco-Innovations' nanoparticle delivery system was built specifically to deal with this challenge. By pairing the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier, the platform extends circulation time and encourages preferential buildup within tumor tissue while reducing exposure to healthy cells.The company has continued advancing its Chemistry, Manufacturing and Controls program alongside its preclinical research. Onco-Innovations is carrying out manufacturing scale-up and formulation development with Dalton Pharma Services, while running IND-enabling studies, including pharmacokinetic and biodistribution work, with Nucro-Technics. The company recently reported successful API process development and intermediate-scale production for its PNKP inhibitor technology, the kind of key manufacturing announcements that reduce risk on the path toward a first-in-human trial.The company has also set up a subsidiary in Australia to back anticipated phase 1 development through the Therapeutic Goods Administration regulatory pathway. Activation of a first-in-human phase 1 trial is planned later this year. The anticipated clinical approach is underpinned by validated preclinical data, a clear regulatory roadmap and the possibility of pursuing Fast Track designation, considering the substantial unmet need across the target indications.Intellectual Property Designed to Protect ExclusivityIntellectual property forms the foundation of value in early-stage drug development. Without critical IP, clinical achievements fail to result in commercial exclusivity. Onco-Innovations has constructed its IP portfolio with that principle firmly in place. The company owns global rights across three separate layers of protection, with each layer reinforcing the others.The first layer covers the core PNKP inhibitor molecules, the foundational drug candidates from which ONC010 and future programs are derived. The second layer covers the nanoparticle delivery science, specifically the polymer-based micellar carrier system that enables effective tumor-targeted delivery of the inhibitors. This delivery technology is not a peripheral feature; it is central to the program's ability to achieve efficacy without unacceptable toxicity. The third layer protects synthetic lethality applications, which outlines how the therapy is matched to specific tumor biology to maximize selective destruction of cancer cells.Collectively, these patents provide comprehensive protection for the PNKP technology and the ONC010 program. The portfolio is designed to included not just the current lead compound but the main platform itself, supporting the company's specified objective of increasing its PNKP inhibitor technology across additional cancer types.For example, the company has wrapped up a collaborative project with Kuano, applying a quantum-based computational chemistry platform to generate insights aimed at optimizing PNKP inhibitor technology, further reinforcing the molecular foundation underlying the program.Causal AI Speeds Up Precision-Focused Trial DesignDrug development remains costly and slow. The typical oncology drug requires more than a decade and over $1 billion to reach the market, and most candidates that enter clinical trials ultimately fail. Artificial intelligence is being applied with growing frequency to improve those odds, not by substituting for biology but by making it easier to identify the right patients, design more effective trials and interpret results more rapidly.With this in mind, last year Onco-Innovations acquired Inka Health Corp. Inka Health's SynoGraph(TM) platform prototype is a proprietary causal AI engine built specifically for oncology applications. Unlike standard machine learning, which identifies statistical correlations, causal AI is designed to reason about cause-and-effect relationships, a difference that carries significant weight in clinical research, where the gap between association and true causation can be the reason a drug appears effective or ineffective.The SynoGraph offering is designed to support patient stratification, clinical trial design, translational decision-making and evidence generation. The exclusive prototype will combine real-world data, clinical evidence and molecular insights to help predict trial outcomes, treatment efficacy and safety, as well as adverse events. For a company preparing to launch a first-in-human trial, the ability to pinpoint the right patient population before the trial even begins represents a meaningful reduction in clinical risk rather than a mere convenience.Inka Health is also working with both AstraZeneca and GlaxoSmithKline in collaborations centered on predictive modeling, real-world evidence and AI-enabled cancer study. These companies are far from minor partners. And last month, Inka Health started a research partnership within PROmAI, additionally broadening the range of applications for the SynoGraph platform.Folding SynoGraph into the ONC010 development program means Onco-Innovations can use AI-driven patient stratification across its planned clinical studies. This provides the potential to shorten enrollment timelines, enhance the signal within early efficacy data and increase the overall potential for success. Precision-focused trial design is increasingly becoming a significant differentiator within oncology, and Onco-Innovations is working to build that capability internally.Biotech Innovation Continues Advancing Patient CareRecent developments across the biotechnology industry highlight continued progress in the development of innovative therapies and preventive treatments for a wide range of serious diseases. Companies are achieving important regulatory milestones, reporting encouraging clinical trial results and advancing next-generation treatment approaches designed to improve patient outcomes.Merck & Co. Inc. (NYSE: MRK) announced that the FDA has approved an expanded indication for CAPVAXIVE(R) (Pneumococcal 21-valent Conjugate Vaccine). The indication will include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the United States for use in this patient population.Pfizer Inc. (NYSE: PFE) announced that the FDA has approved an expanded indication for HYMPAVZI(R) (marstacimab-hncq). The expanded indication includes the treatment of patients, diagnosed with hemophilia A or B, who are 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. HYMPAVZI is now indicated in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.GSK plc (NYSE: GSK) is reporting interim phase 2 data from the global phase 2/3 ROSETTA Lung-02 clinical trial. The trial evaluated the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig, also known as BNT327 or BMS-986545, plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer ("NSCLC"). The data showed encouraging anti-tumor activity, with high response rates observed in both nonsquamous and squamous NSCLC and at each PD-L1 expression level. The data was presented at the 2026 American Society of Clinical Oncology Annual Meeting.Gilead Sciences Inc. (NASDAQ: GILD) announced that the primary efficacy endpoint at Week 48 was met in both the phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY(R) (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified.As scientific innovation continues to accelerate, the biotechnology sector remains at the forefront of transforming healthcare through novel medicines, advanced biologics and precision treatment strategies. These achievements reflect a growing pipeline of therapies that have the potential to reshape treatment standards and deliver meaningful benefits to patients across diverse disease areas.For further information about Onco-Innovations, visit the Onco-Innovations profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, "Biotech" to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment.BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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The Quest to Repair What Multiple Sclerosis Takes AwayJune 24, 2026 9:00 AM
InvestorsHub NewsWireThe Quest to Repair What Multiple Sclerosis Takes AwayBioMedWire Editorial Coverage: Multiple sclerosis ("MS") gradually strips people of command over their own bodies, advancing steadily with no available cure. More than 2.9 million people across the globe are currently living with the disease. But even with generations of scientific study and research, every approved treatment still falls short of one essential objective: bringing the disease to a complete stop. Existing therapies can slow its advance, but none can halt it outright. That shortfall translates into a future of mounting disability for millions of MS sufferers. Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (Profile) is determined working to change that outcome. The company is developing Lucid-MS, a patented, first-in-class drug candidate that approaches the disease from an entirely different angle by directly targeting the myelin sheath that MS destroys; the potential treatment is now preparing to move into phase 2 clinical trials. Quantum BioPharma stands among a group of companies pursuing therapies for neurological, autoimmune and immune-mediated conditions, a group that also includes Novartis AG (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK), TG Therapeutics Inc. (NASDAQ: TGTX) and Bristol Myers Squibb Company (NYSE: BMY).Multiple sclerosis is especially destructive because of its tendency to worsen progressively.Instead of working through the immune system, Quantum BioPharma's Lucid-MS acts directly on the myelin sheath.The scientific case behind Lucid-MS rests on years of disciplined research.Quantum BioPharma has finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302.Click here to view the custom infographic of the Quantum BioPharma editorial.A Disease That Erodes Movement, IndependenceMultiple sclerosis is a long-term inflammatory condition affecting the central nervous system. In MS, the immune system mistakenly attacks the brain and spinal cord, damaging myelin, the protective coating around nerve fibers that allows electrical impulses to travel efficiently. As myelin breaks down, these signals slow, falter or fail altogether, resulting in a mix of symptoms that can include tingling, vision disturbances, mobility difficulties, cognitive decline and, over time, a progressive erosion of physical control.MS does not spare any age group. The worldwide average age at diagnosis is 32, with an estimated 1.5% of all those with MS diagnosed before turning 18. Women receive an MS diagnosis at twice the rate of men. Within the United States alone, close to one million people are currently living with the disease in the United States, a number that more than doubled over earlier figures once researchers applied more rigorous, contemporary counting methods. Unfortunately, the trend continues upward, with prevalence climbing in every region of the world since 2013.In addition, MS is especially destructive because of its tendency to worsen progressively. Many patients initially experience a relapsing-remitting pattern, in which symptoms flare and then partially subside. Over time, however, a substantial share of patients shift into secondary progressive MS, a phase marked by steadily accumulating disability. According to the National MS Society, many people with MS end up juggling several medications at once, with each med addressing a separate symptom or relapse episode, yet none capable of confronting the underlying nerve damage that continues to erode their quality of life.The disease also imposes a substantial financial toll. The worldwide market for MS therapeutics was valued at roughly $27.4 billion in 2024 and is projected to climb to $38.62 billion by 2030, a trajectory driven not by curative treatments but by the sheer volume of patients requiring care across their lifetimes. That market dynamic highlights just how large the unmet need truly is. Patients require more than ongoing management; they need a therapy capable of interrupting the disease process itself.That is exactly the objective Quantum BioPharma has set out to achieve. The company is advancing Lucid-MS, a patented, first-in-class drug candidate unlike any therapy currently on the market, one engineered to act on the myelin sheath directly with the aim of preventing and protecting its breakdown.Acting Directly on the Myelin SheathThe majority of approved MS treatments function by modulating the immune system. They subdue or redirect the immune response responsible for attacking myelin, an approach that can lower relapse frequency and slow the buildup of disability. These therapies have delivered genuine clinical progress. Yet none of them directly address the myelin tissue itself or work to rebuild what has already been lost. For patients in the progressive stages of MS, immune modulation alone frequently proves inadequate.Lucid-MS charts an entirely separate course. Known technically as Lucid-21-302, the candidate is a patented New Chemical Entity, classified as a first-in-class, nonimmunomodulatory, neuroprotective compound. Instead of working through the immune system, Lucid-MS acts directly on the myelin sheath. In preclinical models, it has demonstrated the ability  to protect  myelin from degradation, a key pathological process  underlying multiple sclerosis. No currently approved treatment offers a comparable mechanism of action.A defining feature of Lucid-MS is that it does not impact immune function. That quality separates it from most existing MS therapies and may translate into a meaningful safety benefit. It also frames Lucid-MS not as a substitute for immune-modulating drugs but as a potential complement to them, or should future trial results support its early promise, as a foundational therapy in its own right. The drug is also being advanced in an oral form, which would offer patients greater convenience than the injectable or infusion-based treatments many currently rely on.Quantum BioPharma controls exclusive global rights to Lucid-MS through its wholly owned subsidiary, Lucid Psycheceuticals Inc. The program is guided by a top-tier scientific team that includes advisor Dr. Lakshmi P. Kotra, recipient of the Julia Levy Award, a senior scientist at the University Health Network and a professor of medicinal chemistry at the University of Toronto. The scientific team also includes Dr. Andrzej Chruscinski, vice president of Scientific and Clinical Affairs, whose career spans Stanford-trained internal medicine alongside cardiology and neurological research. This group is working toward something no approved drug has yet accomplished: an MS therapy that directly safeguards myelin.From Laboratory Findings to Human StudiesThe scientific case behind Lucid-MS rests on years of disciplined research. The compound has undergone study for upward of a decade, with findings published in some of medicine's most respected journals, including the "Journal of Medicinal Chemistry" and the "Proceedings of the National Academy of Sciences." These peer-reviewed papers track the compound's indicated capacity to prevent demyelination in preclinical settings.The animal-model results are notable. Across experiments carried out in multiple laboratories over the course of several years, Lucid-MS sped up functional recovery in mouse models of MS, preserved myelin integrity and reduced regional degradation. Documented results report that, following treatment, mice regain the capability to walk. This outcome did not stem from isolated experiments but from an extensive body of studies. The results proved compelling enough to justify advancing the compound into human trials.Quantum BioPharma presented its phase 1 clinical trial application for Lucid-MS to evaluate first-in-human safety and tolerability in 2023. The trial encompassed both Single Ascending Dose ("SAD") and Multiple Ascending Dose ("MAD") phases, which were administered among healthy volunteers. Results from the clinical study report identified no safety or tolerability concerns associated with daily dosing. Dosing in phase 1 among healthy human volunteers was successfully completed, with Lucid-MS characterized as exhibiting a favorable safety profile and good tolerability.Should upcoming phase 2 trials in MS patients confirm what the preclinical work suggested — that Lucid-MS can stop and prevent myelin degradation — it would represent an unprecedented milestone. No therapy currently approved for MS has shown the ability to help patients regain physical function previously lost to myelin damage. While human trials remain necessary to determine whether the preclinical results carry over to patients, a decade's worth of accumulated data provides a scientifically credible basis for that optimism.Submitting the IND, Preparing for Phase 2Late last year, the company finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. These studies represent essential elements of the Investigational New Drug ("IND") application that the U.S. Food and Drug Administration ("FDA") requires before authorizing a phase 2 trial. Completing these extended safety studies marked a meaningful advance toward formal regulatory submission.The company additionally entered into agreements with a leading contract development and manufacturing organization to develop and produce an oral formulation of Lucid-MS, a critical step in preparing the drug for clinical use. Following that, in April this year, Quantum BioPharma officially filed its IND application with the FDA for Lucid-MS, aiming for a phase 2 trial designed to assess the therapy's efficacy, safety and tolerability among people living with MS.To carry out a phase 2 trial, Quantum BioPharma announced a binding letter of intent with Allucent, a global contract research organization with extensive experience running central nervous system trials. Quantum BioPharma also named a principal investigator for the upcoming trial, marking further progress in the clinical development program. These steps are indicative of an organization that has advanced methodically from encouraging preclinical results to taking the steps towards producing the human clinical data the MS community is waiting for.A Pioneering Partnership Sheds Light on the Path ForwardQuantum BioPharma is concurrently working with a tool that could prove vital to assessing Lucid-MS's effectiveness: an advanced imaging technique capable of directly visualizing myelin within the living human brain. Quantum BioPharma recently launched a joint clinical study with researchers at Massachusetts General Hospital ("MGH") to validate a novel positron emission tomography imaging method for tracking myelin integrity and demyelination in MS.The study centers on a PET tracer known as [¹8F]3F4AP, developed by Dr. Pedro Brugarolas, who is an investigator in the Department of Radiology at MGH and an assistant professor at Harvard Medical School. Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and an associate professor of neurology at Harvard Medical School, is co-investigator on the project.In June of last year, the first patient with MS was scanned successfully, which marked the formal start of active patient enrollment. The MGH research team also published encouraging results in the "European Journal of Nuclear Medicine and Molecular Imaging," in a study funded by the National Institutes of Health. The tracer exhibited strong properties for brain imaging and, notably, was able to distinguish differences among lesions that conventional MRI could not detect. Last month, the study reached the midpoint of patient enrollment, with preliminary imaging results showing encouraging signal strength in acute MS lesions.The importance of this imaging work to Lucid-MS's development is difficult to overstate. One of the central challenges in developing any remyelinating therapy is confirming whether it is genuinely working, and conventional MRI cannot provide a direct, quantitative measure of myelin. Assuming it is validated, the [¹8F]3F4AP tracer could supply precisely that: a real-time biological window into how effectively a drug is protecting or restoring the myelin sheath.Chruscinski has noted that this tool has the potential to fundamentally reshape how demyelination is assessed, offering a direct view into axonal health and enabling clearer demonstration of how therapies such as Lucid-MS perform. This collaboration among the University Health Network, Massachusetts General Hospital and researchers affiliated with Harvard Medical School brings together world-class scientific expertise around a common purpose.Quantum BioPharma is laser focused on that objective. With the global MS therapeutics market projected to surpass $38 billion by 2030, the commercial stakes involved are substantial. Yet for the nearly three million people living with MS worldwide, what matters most is whether a therapy can finally achieve what none has accomplished before: Halting the disease, repairing the damage it causes and restoring the bodily control that MS has taken away. Should Lucid-MS fulfill its preclinical promise in human trials, it would represent more than a new drug; it would mark a genuine turning point.Advancing Treatment Options Across SectorsRecent developments across the biopharmaceutical industry highlight continued momentum in the development of therapies for autoimmune, immune-mediated and chronic inflammatory diseases. Companies are reporting encouraging clinical results, expanding development programs and achieving important regulatory milestones as they work to address conditions that can significantly impact quality of life and often remain difficult to treat.Novartis AG (NYSE: NVS) presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology ("EAACI") Congress. The data showed that Rhapsido(R) (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines.Merck & Co. Inc. NYSE: MRK) announced positive topline results from the phase 3 ATLAS-UC induction-only study (study 2). The study evaluated tulisokibart ("MK-7240"), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A ("TL1A"), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score at week 12, as well as key secondary endpoints. In addition, consistent with previously reported phase 2 studies, no safety concerns were identified.TG Therapeutics Inc. (NASDAQ: TGTX) reported positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis. The company also announced theinitiation of a phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. The company noted that the encouraging results support continued development of BRIUMVI in MG and also mark an important milestone in expanding the potential utility of BRIUMVI beyond multiple sclerosis.Bristol Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo(R) (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and adolescent patients 12 years of age and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma. This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced cHL.As scientific understanding of immune system dysfunction continues to evolve, researchers are uncovering new therapeutic targets and refining treatment strategies across a broad range of diseases. These efforts reflect a growing focus on delivering therapies that offer greater efficacy, convenience and durability while helping address substantial unmet medical needs.For further information about Quantum BioPharma Ltd., visit the Quantum BioPharma profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, "Biotech" to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. 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The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/DisclaimerBioMedWire
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European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First PD-1 Inhibitor Plus Antibody-Drug Conjugate Regimen for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder CancerJune 24, 2026 6:45 AM
Business Wire Approval based on results from the Phase 3 KEYNOTE-905 trial in which perioperative KEYTRUDA plus Padcev reduced the risk of event-free survival events by 60% and risk of death by 50% versus surgery alone in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), is approved in the European Union (EU), as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval, which also covers KEYTRUDA SC® [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU. This approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. KEYTRUDA plus Padcev reduced the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p

Merck’s Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC)June 22, 2026 6:45 AM
Business Wire Tulisokibart is the first anti-TL1A monoclonal antibody to demonstrate clinical remission at 12 weeks in moderately to severely active UC in a Phase 3 trial Tulisokibart was designed to help address immuno-fibrosis, a key driver of disease progression in inflammatory bowel disease (IBD) and other immune-mediated inflammatory conditions Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score (MMS) at week 12, as well as key secondary endpoints. Consistent with previously reported Phase 2 studies, no safety concerns were identified. “These positive Phase 3 induction results for tulisokibart are the first for an anti-TL1A biologic. They represent an important step forward for patients with moderately to severely active ulcerative colitis who – despite available treatments – continue to experience symptoms, and do not achieve clinical remission,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These results reinforce the potential of this novel approach designed to help address immuno-fibrosis, a key driver of chronic immune dysregulation and disease progression in ulcerative colitis.” Results from the ATLAS-UC Study 2 will be presented with the results from the ongoing induction and maintenance study (Study 1) at an upcoming scientific congress and will be shared with regulatory authorities. Tulisokibart has the broadest development program in the novel anti-TL1A class and is currently being evaluated in seven disease indications. Phase 3 studies include ATLAS-UC (NCT06052059) in UC and ARES-CD (NCT06430801) in Crohn’s disease (CD). Phase 2 studies are evaluating tulisokibart in systemic sclerosis-associated interstitial lung disease (SSc-ILD) (NCT05270668), rheumatoid arthritis (RA) (NCT07176390), psoriatic arthritis (PsA) (NCT07486960), radiographic axial spondyloarthritis (r-axSpA) (NCT07133633) and hidradenitis suppurativa (HS) (NCT06956235). For an overview of Merck’s clinical development program in immunology, please click here. About ATLAS-UC
ATLAS-UC (NCT06052059) is a Phase 3, randomized, double-blind, placebo-controlled program designed to evaluate the efficacy and safety of tulisokibart in adults with moderately to severely active ulcerative colitis (UC). The program consists of two independent studies: Study 1, which includes both induction and maintenance treatment, and Study 2, which includes only induction treatment. Study 2 is investigating whether at least one tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission, according to the MMS at week 12. Participants were randomized to either receive a high dose IV of tulisokibart, a low dose IV of tulisokibart or an IV placebo. Key secondary endpoints at week 12 include percentage of patients who experienced endoscopic improvement, percentage of patients who achieved clinical response per MMS and percentage of patients who demonstrated histologic-endoscopic mucosal improvement. About Ulcerative Colitis
Ulcerative colitis (UC) is one of the most common types of IBD and is a chronic progressive immuno-fibrotic disease that affects the large intestine and rectum. Recent evidence suggests that UC involves not only the mucosa but also deeper transmural changes with fibrosis in the colorectal wall. Millions of people worldwide live with UC, and symptoms can be unpredictable and may significantly impact quality of life. UC often follows a relapsing and remitting course, with symptoms that may include diarrhea, rectal bleeding, abdominal pain, bowel urgency and weight loss. Many patients with UC do not achieve adequate disease control despite the availability of currently approved treatments. About Tulisokibart
Tulisokibart is an investigational humanized monoclonal antibody directed to a novel target, TL1A, that is associated with both intestinal inflammation and fibrosis (immuno-fibrosis). Tulisokibart is thought to bind both soluble and membrane-bound TL1A. Merck is developing tulisokibart for the treatment of immune-mediated inflammatory diseases, including UC, CD, SSc-ILD, RA, PsA, r-axSpA and HS. About Immuno-fibrosis
Immuno-fibrosis is the process by which inflammation and fibroblast activation drive disease activity and progression in many autoimmune conditions, including UC. Immuno-fibrotic diseases are chronic progressive conditions marked by immune dysregulation, inflammation and fibroblast activation. The impact of immuno-fibrosis may vary by disease, stage and patient. The complexity of immuno-fibrosis underscores the need for treatment options that address both inflammation and fibrosis. Merck is advancing research to deepen the understanding of immuno-fibrosis and help translate the science into new approaches. Merck’s Commitment to Immunology
Advances in our understanding of human biology have led to the emergence of innovative medicines and new modalities that aim to change approaches to the treatment of immune-mediated inflammatory diseases. Merck scientists are leveraging deep expertise in immunology to discover and develop therapies to help people living with these conditions. Our research is focused on investigating novel targets such as TL1A and CD30L, as well as newer modalities like T-cell engagers, and exploring their potential across a range of immune-mediated inflammatory diseases. About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260622057174/en/ Media Contacts:
Julie Cunningham
julie.cunningham@merck.com Jalisa Stanislaus
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(732) 594-0482 Original: Merck’s Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

U.S. FDA Approves an Additional Indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal DiseaseJune 18, 2026 6:45 AM
Business Wire CAPVAXIVE is the only Pneumococcal Conjugate Vaccine (PCV) specifically indicated and studied in the U.S. for use in this population CAPVAXIVE, when added to existing primary pediatric pneumococcal vaccination series, helps deliver additional protection by including serotypes not contained in approved primary pediatric PCV series Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the U.S. for use in this patient population. CAPVAXIVE is indicated for: Active immunization for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older and individuals 2 through 17 years of age who are at increased risk for pneumococcal disease; Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. “Children and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections,” said Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus, investigator, STRIDE-13 trial. “This approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series, and represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease.” The approval is based on data from the Phase 3 STRIDE-13 trial, which evaluated CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 through 17 years who completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. See “STRIDE-13 Clinical Data Supporting Approval” below for additional details. “While CAPVAXIVE was specifically designed for adults, it may also offer additional disease protection for this specific population of children and adolescents, when given after the primary pediatric pneumococcal vaccination series,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. “The approval of CAPVAXIVE for children and adolescents at increased risk for pneumococcal disease demonstrates our commitment to addressing this disease in people of all ages, not only addressing an unmet need, but also reinforcing Merck’s longstanding commitment to public health and infectious diseases.” The expanded indication for CAPVAXIVE complements existing primary pediatric pneumococcal vaccination series for children and adolescents at increased risk for pneumococcal disease. According to a 2025 study of 2015-2019 CDC ABC surveillance data, including three groups, one of which consisted of children 10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). The most commonly reported (>10%) solicited adverse reactions in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease were: injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%). Vaccination with CAPVAXIVE may not protect all vaccine recipients. STRIDE-13 Clinical Data Supporting Approval STRIDE-13 (NCT06177912) is a randomized, double-blind, active comparator-controlled Phase 3 study that evaluated individuals 2 through 17 years of age with one or more prespecified medical conditions (diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, chronic lung disease) known to increase the risk of pneumococcal disease and who have previously completed a primary pneumococcal vaccination regimen at least 8 weeks prior to enrollment (n=874). Participants were randomized 3:2 to receive a single dose of CAPVAXIVE (n=527) or PPSV23 (n=347). Results from the study include: CAPVAXIVE was noninferior to PPSV23 for the 12 shared serotypes and induced statistically significantly greater OPA GMTs compared to PPSV23 for the 9 serotypes unique to CAPVAXIVE; CAPVAXIVE also elicited immune responses to serotype 15B (cross-reactive to serotype 15C). In a post hoc analysis utilizing the same prespecified noninferiority criterion that was used for the shared serotypes, CAPVAXIVE was noninferior to PPSV23 for serotype 15B; The safety profile of CAPVAXIVE was generally comparable to PPSV23. Solicited adverse reactions following administration of CAPVAXIVE lasted a median of 2 days with most reactions lasting ≤3 days; The proportion of individuals reporting 1 or more serious adverse events (SAE) within 6 months postvaccination was 5.5% (n=29) in individuals vaccinated with CAPVAXIVE and 7.2% (n=25) in individuals vaccinated with PPSV23. There were no notable patterns or imbalances between vaccine groups for SAEs. One individual (0.2%) who received CAPVAXIVE had an SAE considered related to vaccination. This SAE was syncope (Grade 2, required hospitalization) and occurred approximately 3 minutes postvaccination. About Pneumococcal Disease Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Please see the Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf and the Patient Information/Medication Guide for CAPVAXIVE at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf . View source version on businesswire.com: https://www.businesswire.com/news/home/20260618416609/en/ Media Contacts: Olivia Finucane
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alayna.shamy@merck.com Investor Contacts: Peter Dannenbaum
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damini.chokshi@merck.com Original: U.S. FDA Approves an Additional Indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal Disease

Study Reveals Dog Owners and Veterinarians See Challenges in Treating Allergic Skin Disease, Highlighting a Need for a Targeted Rapid Onset Treatment for Dogs of All AgesJune 17, 2026 6:45 AM
Business Wire Efficacy and safety are top preferences when selecting antipruritic treatments, but dog owners and veterinarians want options that are easier to administer, more affordable and improve compliance Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced results from a new global survey of dog owners and veterinarians revealing challenges and pain points associated with diagnosing the underlying cause of allergic skin disease in dogs and its treatment. According to Pet Owner and Vet Perspectives on Canine Pruritus: A Global Survey, about one-third of canine patients seen by U.S. veterinarians have itchy skin or allergic skin disease (27% of global canine patients) and about two in five dogs with skin conditions are newly diagnosed (U.S. and global). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617911309/en/ Both dog owners and veterinarians feel fatigued and burdened by canine allergic skin disease, with 34% of U.S. dog owners reporting a notable negative impact on their own quality of life (31% globally). Additionally, 43% of dog owners who have dogs with itchy skin in the U.S. (39% globally) indicated a significant negative impact on the dog's quality of life. In fact, 86% of U.S. dog owners (90% globally) who have taken their dog with scratchy/itchy skin to the vet have discussed their dog’s itch with their vet with 61% of those dog owners specifically making the appointments with their veterinarian to discuss their pet’s itchy skin (60% globally). The survey also revealed that both dog owners and veterinarians have difficulty finding an effective treatment, with 28% of U.S. dog owners and 36% of U.S. veterinarians having switched therapies used to treat allergic skin disease in the last year (compared to globally 29% and 41%, respectively). To access vet and pet owner resources, click here. “Allergic skin disease is one of the most common clinical signs among dogs of all ages. Knowing that many dog owners and veterinarians are managing dogs with allergic skin disease, we wanted to understand the challenges they are facing when it comes to diagnosis, treatment, and compliance,” said Linda Horspool, BVMS, PhD, DipECVPT, FRCVS, Director Scientific Marketing Affairs, Global Marketing Companion Animals, Merck Animal Health. “We found that while veterinarians and owners both experience frustrations when communicating with one another about diagnosing the underlying cause of allergic skin disease and treatment plans, both parties have the same goal of finding a solution that is effective, safe and starts working fast.” The insights from 1,710 dog owners and 1,413 veterinarians across 11 countries (8 countries for dog owners) revealed notable differences in their preferences, priorities and motivations for treating allergic skin disease in dogs. The findings underscore that dog owners and veterinarians both prioritize improving the quality of life of patients, but there are gaps in communication about the underlying cause of allergic skin disease, what to expect, the treatment selected, and how compliance impacts efficacy. Key Findings When selecting antipruritic therapies for their dogs, the top three features U.S. owners look for are efficacy, safety and specifically targeting itch.
When asked to select the features they felt are most important in a treatment for their itchy dog, owners in the U.S. and globally ranked effectiveness for itch as most important, safety profile as second most important and targeted for itch as third most important in the highest tier of importance. Globally and in the U.S. veterinarians ranked effectiveness and rapid onset as the most important features.
Despite listing safety and efficacy as a feature of most importance, antihistamines and corticosteroids use remains high
In dogs, antihistamines can cause drowsiness or hyperactivity, long-term or high-dose corticosteroids can lead to serious issues like immune suppression, vomiting, diarrhea, and Cushing's disease. Yet, 41% of U.S. dog owners report having used antihistamines to treat canine allergic skin disease in the last year (27% globally), while 23% report using corticosteroids (19% globally). Fifteen percent report using JAK inhibitors (11% globally), and 8% report using monoclonal antibodies (11% globally), which typically have fewer safety concerns and side effects.i
Veterinarians and dog owners in the U.S. stopped using antipruritic treatment for the same top reasons – lack of efficacy and safety concerns.
For U.S. dog owners, the top reasons they discontinued use of antipruritic treatment were because the product was not as effective as they’d like it to be (32%), the product was too costly/expensive (28%), they had safety concerns (21%), and one dose did not last long enough (21%). For U.S. veterinarians, 44% cited poor efficacy, 38% cited less targeted treatment, and 28% cited poor safety profile. While U.S. dog owners and veterinarians were aligned, global dog owners differed with top reasons being poor efficacy (22%), slow to start (20%), and my dog did not enjoy receiving it (18%). Globally, veterinarians also most frequently cited poor efficacy (46%), less targeted treatment (31%), and poor safety profile (27%).
Both veterinarians and dog owners were motivated to start using a treatment that was easier to administer and improved compliance.
U.S. dog owners who started a new treatment cited top factors for starting the treatment as recommended by veterinary staff (40%), safer for my dog (38%), and easier to administer or apply to my dog (35%). Reasons why U.S. veterinarians started recommending a treatment were: better efficacy (46%), innovative treatment that adds to the toolbox (44%), better client compliance (28%), more targeted treatment (26%) and price (26%). Globally, dog owners cited recommended by my vet (32%), easier to administer or apply to my dog (32%), and safer for my dog (31%). Globally, veterinarians cited better efficacy (48%), innovative treatment that adds to the toolbox (36%), more targeted treatment (32%),faster onset of action (27%) and better client compliance (26%).
Some available treatments come with a cost burden. When asked about unmet needs in current antipruritic treatments, the majority of veterinarians said there was a gap in cost effective, more affordable options.
52% of U.S. veterinarians and 46% of veterinarians globally said the top unmet need for canine antipruritic treatment is more cost-effective options. Additionally, about 1 in 10 veterinarians globally (6% of U.S. veterinarians) said medication for dogs 6 months of age or older was an unmet need. 13% of dogs with allergic skin conditions seen by veterinarians worldwide were 6–11 months old (9% in the US) and therefore too young to receive a JAK inhibitor that is approved for dogs 12 months and older.
Additional global qualitative findings suggest that both dog owners and veterinarians desire better communication and understanding of treatment plans and disease progression/ what to expect.
Interviews with 60 veterinarians and 25 dog owners from across five countries including the U.S. revealed key themes around the allergic skin disease journey. The chronic nature and variability of the condition make it difficult to manage from patient to patient, leading to veterinarian fatigue. Veterinarians also reported that pet owners have a misunderstanding of the chronic nature of allergic skin disease and how treatments work, causing compliance to suffer. Meanwhile, pet owners shared that they try to create a routine, but some are forced to spread out doses to counteract costs. Many owners also reported not receiving enough information or instruction from their veterinarian. Study Methodology This quantitative study collected data through an online survey administered by a professional market research organization, adhering to global market research guidelines and codes of conduct. The study captured data from a representative sample of 1,413 companion animal veterinarians across 11 countries: the US, Canada, Australia, Japan, Brazil, Mexico, UK, France, Germany, Spain, and Poland. Data was also captured among a representative sample of 1,710 dog owners across 8 countries: the US, Canada, Australia, Mexico, UK, France, Germany, and Spain. Qualifying dog owner participants were 18+ years of age, owned 1–4 dogs and were primary or shared decision makers regarding their dog’s healthcare. They had to own a dog that has exhibited or been treated for signs of atopic/allergic dermatitis in the past 12 months (includes both diagnosed and undiagnosed dogs). To reduce bias, participants affiliated with animal health companies or market research firms were excluded. The study targeted a representative sample of owner demographics, including geography, gender, age and household income. The survey took approximately 24 minutes to complete and was conducted from 20 February to 16 April 2025. Qualified respondents were asked about their dog’s condition, diagnosis, and impact of the disease, followed by a series of questions assessing treatment use, frequency of treatment, and perception of treatments. They were also asked to provide their thoughts on factors driving them to select a treatment, and factors that identify an ideal treatment, also to provide their opinions on a potential new product concept for allergic skin conditions. If a respondent had multiple dogs, they were asked to focus on the dog that has exhibited or been treated for signs of atopic/allergic dermatitis in the past 12 months. Qualifying veterinarian participants were full-time veterinarians who personally see itchy/pruritic dogs including atopic dermatitis cases, had been practicing veterinary medicine for 2–40 years, were primary/co-decision makers regarding products recommended or prescribed at their practices. The study targeted a representative mix of participant demographics, such as gender and age, and practice demographics, such as location, size and ownership type (corporate versus independent). Participants were excluded if they were competitively employed or serving in an advisory capacity to animal health, market research and/or pharmaceutical companies. The survey was fielded from 4 November 2024 to 13 January 2025 and took approximately 38 minutes to complete. Qualified participants answered questions assessing their canine patient load with the disease, their approach to treatment of allergic skin conditions, their perceptions of treatments, and the key factors that drive their selection of treatments. They were also asked to provide their opinions on a potential new product concept for allergic skin conditions. Responses were collected and reviewed in an anonymized format. Open, free-text responses were grouped according to subject. Analysis consisted of descriptive analytics. About Merck Animal Health Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). ### i Sousa CA. Glucocorticoids in veterinary dermatology. In: Bonagura JD, Twedt DC, eds. Kirk's Current Veterinary Therapy. 14th ed. St Louis, MO: Saunders Elsevier; 2009:400-404. View source version on businesswire.com: https://www.businesswire.com/news/home/20260617911309/en/ Merck Investor Contacts:
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(732) 594-1579 Merck Media Contacts:
Kim Gorode
ahglobalmedia@merck.com Original: Study Reveals Dog Owners and Veterinarians See Challenges in Treating Allergic Skin Disease, Highlighting a Need for a Targeted Rapid Onset Treatment for Dogs of All Ages

FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC)June 12, 2026 4:10 PM
Business Wire Marks the first approved combinations of a PD-1 and HIF-2a inhibitor Approvals based on Phase 3 LITESPARK-022 trial that showed KEYTRUDA in combination with WELIREG reduced the risk of disease recurrence, metastasis or death by 28% compared to KEYTRUDA plus placebo Represents the first and only global Phase 3 study to have demonstrated an improvement in disease-free survival over KEYTRUDA monotherapy in adjuvant ccRCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2a inhibitor combination regimens. The approvals are based on results from the pivotal Phase 3 LITESPARK-022 trial. LITESPARK-022 enrolled 1,841 patients and demonstrated that KEYTRUDA in combination with WELIREG significantly improved disease-free survival (DFS), the trial’s primary endpoint, reducing the risk of disease recurrence, metastasis or death by 28% (HR=0.72 [95% CI 0.59-0.87]; p=0.0003) for patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared to KEYTRUDA plus placebo. The estimated 24-month DFS rate was 81% (95% CI 0.78-0.83) with KEYTRUDA plus WELIREG compared to 74% (95% CI 0.71-0.77) with KEYTRUDA plus placebo. Median DFS was not reached in either arm. Overall survival (OS) results were not yet mature at this interim analysis. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA. The WELIREG prescribing information contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective. WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For more information, see “Selected Safety Information” below. KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA and KEYTRUDA QLEX are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions in any or multiple organs, which can occur during or after treatment, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection; severe and life-threatening infusion or injection-related reactions; fatal and other serious complications in patients who receive allogeneic hematopoietic stem cell transplantation before or after beginning treatment; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when KEYTRUDA or KEYTRUDA QLEX is added to a thalidomide analogue plus dexamethasone, which is not recommended outside of controlled trials. Immune-mediated adverse reactions listed here may not include all such possible severe or fatal reactions. For more information, see “Selected Safety Information” below. “Patients with earlier-stage renal cell carcinoma at high risk of recurrence after surgery may see their cancer return, frequently as metastatic disease,” said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School. “The results of the LITESPARK-022 trial demonstrated the ability of pembrolizumab in combination with belzutifan to reduce the risk of disease recurrence, metastasis, or death by 28%, which represents an important new option for these patients to help keep their clear cell renal cell carcinoma from coming back.” “Reflecting on my own experience as a clinical oncologist, I know the significant impact that improved disease-free survival can have on the lives of patients,” said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. “These approvals demonstrate Merck’s commitment to pursuing innovative treatment options that may help these patients experience longer periods without disease.” “The FDA approval of the novel KEYTRUDA and WELIREG combination is exciting news for the kidney cancer community,” said Bryan Lewis, CEO and co-founder, KidneyCan. “This progress reflects an important step in addressing the needs of patients with earlier-stage renal cell carcinoma.” Study design and additional data from LITESPARK-022 LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to placebo plus KEYTRUDA for the adjuvant treatment of ccRCC post nephrectomy. Eligible patients had intermediate-high or high risk of recurrence of RCC, or M1 no evidence of disease (NED). Patients must have undergone a partial or radical nephrectomy, and if indicated, metastasectomy within two years of nephrectomy, within ≥4 weeks prior to the time of screening. Patients were excluded from the trial if they had received prior systemic therapy for advanced RCC. The trial enrolled 1,841 patients who were randomized (1:1) to receive either: WELIREG (120 mg orally once daily) plus KEYTRUDA (400 mg intravenously [IV] every six weeks) for up to 9 cycles (54 weeks) until disease recurrence or unacceptable toxicity (n=921), or; KEYTRUDA (400 mg IV every six weeks) plus oral placebo for up to 9 cycles (54 weeks) until disease recurrence or unacceptable toxicity (n=920). The major efficacy outcome measure was investigator-assessed DFS and an additional outcome measure was OS. The safety of WELIREG in combination with KEYTRUDA was evaluated in LITESPARK-022. A total of 915 patients received WELIREG in combination with KEYTRUDA and a total of 913 patients received oral placebo in combination with KEYTRUDA. The median duration of exposure to WELIREG was 12.4 months (range 1 day to 20.1 months). The median duration of exposure to KEYTRUDA in the treatment arm was 11.1 months (range: 1 day to 16.1 months). Serious adverse reactions occurred in 30% of patients who received WELIREG in combination with KEYTRUDA. The most frequently reported serious adverse reactions (≥1%) were pneumonia (2%), hypoxia (1.9%), pneumonitis (1.6%), arrhythmia (1.5%), diarrhea (1.1%), and acute kidney injury (1.1%). Fatal adverse reactions occurred in 1.1% of patients who received WELIREG in combination with KEYTRUDA, including sepsis (0.1%). WELIREG was permanently discontinued due to adverse reactions in 27% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG in ≥1% of patients included anemia (4%), fatigue (2.2%), rash (2%), increased alanine aminotransferase (ALT) (1.7%), hypoxia (1.6%), diarrhea (1.4%), pneumonitis (1.3%), increased aspartate aminotransferase (AST) (1.1%), and hepatic function abnormal (1%). KEYTRUDA was permanently discontinued due to adverse reactions in 23% of patients. Adverse reactions which resulted in permanent discontinuation of KEYTRUDA in ≥1% of patients included increased ALT (4.5%), increased AST (3%), pneumonitis (2.4%), diarrhea (2.4%), and rash (1.5%). Dosage interruptions of WELIREG due to an adverse reaction occurred in 52% of patients. Of the patients who received WELIREG in combination with KEYTRUDA, 30% were ≥65 years old and 5% were ≥75 years old. Dose interruptions of WELIREG occurred in 57% of patients ≥65 years of age and in 49% of younger patients. Adverse reactions which required dosage interruption of WELIREG in ≥2% of patients included anemia (25%), fatigue (3.7%), increased ALT (3.5%), diarrhea (3.4%), increased AST (3.4%), COVID-19 (2.6%), hypoxia (2.5%), pyrexia (2.5%), musculoskeletal pain (2.1%), and rash (2.1%). Dose interruptions of KEYTRUDA due to an adverse reaction occurred in 29% of patients. Adverse reactions which required dosage interruption of KEYTRUDA in ≥2% of patients included anemia (3.2%), diarrhea (3%), increased ALT (3%), and increased AST (2.5%). Dose reductions of WELIREG due to an adverse reaction occurred in 34% of patients. Dose reductions of WELIREG occurred in 39% of patients ≥65 years of age and in 32% of younger patients. Adverse reactions which required dose reduction in ≥3% of patients included anemia (17%), hypoxia (3.5%), increased ALT (3.2%), and fatigue (3.1%). The most common (≥25%) adverse reactions, including laboratory abnormalities, in patients who received WELIREG in combination with KEYTRUDA were decreased hemoglobin (95%), increased ALT (57%), fatigue (49%), increased AST (46%), decreased lymphocytes (38%), and increased alkaline phosphatase (29%). About renal cell carcinoma Renal cell carcinoma (RCC) is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. In the U.S., it is estimated there will be more than 80,000 new cases of kidney cancer diagnosed and more than 15,000 deaths from the disease in 2026. Renal cell carcinoma is about twice as common in men as in women. Cases of RCC might be discovered incidentally during imaging tests for other reasons. Clear cell renal cell carcinoma, which accounts for 70% of RCC diagnoses, is the most common subtype. About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About Merck’s research in genitourinary cancers Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers. About WELIREG® (belzutifan) 40 mg tablets, for oral use WELIREG, Merck’s first-in-class hypoxia-inducible factor 2 alpha (HIF-2a) inhibitor, is an orally administered small-molecule that in conditions of hypoxia or impairment of VHL protein function, blocks HIF-2alpha and HIF-1beta interaction, which may reduce the transcription and expression of HIF-2a target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2a signaling, WELIREG may disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival. WELIREG has received prior regulatory approvals in certain patients with von Hippel-Lindau (VHL) disease-associated tumors, advanced renal cell carcinoma with a clear cell component (ccRCC) and pheochromocytoma or paraganglioma (PPGL). As part of a broader clinical program, Merck continues to research WELIREG for people with RCC and selected solid tumors across different treatment settings, to further understand where WELIREG may provide clinical benefit. Indications for WELIREG (belzutifan) in the U.S. von Hippel-Lindau (VHL) disease WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Renal Cell Carcinoma with a Clear Cell Component (ccRCC) WELIREG, in combination with KEYTRUDA or KEYTRUDA QLEX, is indicated for the adjuvant treatment of adult patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. WELIREG is indicated for the treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Pheochromocytoma or Paraganglioma (PPGL) WELIREG is indicated for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Selected Safety Information for WELIREG Warning: Embryo-Fetal Toxicity Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective. Anemia WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. Transfuse patients as clinically indicated. Withhold, reduce dose, or permanently discontinue WELIREG based on severity. In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established. In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced ccRCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs. In LITESPARK-022 (n=915), decreased hemoglobin occurred in 95% of patients receiving adjuvant treatment for ccRCC and 11% had Grade 3 or higher events. Median time to onset of anemia was 42 days (range: 1 day to 11.1 months). Of the patients with anemia, 5% received transfusions only, 8% received ESAs only, and 1.3% received both transfusion and ESAs. In LITESPARK-015 (n=72), anemia occurred in 96% of patients with PPGL and 22% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 22.1 months). Of the patients with anemia, 20% received transfusions only, 26% received ESAs only, and 6% received both transfusion and ESAs. Hypoxia WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter 3% of patients were hypoxia, nausea, and fatigue (4.2% each). Dose reductions due to an adverse reaction occurred in 14% of patients. The most frequently reported adverse reaction which required dose reduction was hypoxia (4.2%). The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients were anemia (96%), fatigue (56%), musculoskeletal pain (56%), decreased lymphocytes (54%), increased alanine aminotransferase (51%), increased aspartate aminotransferase (42%), increased calcium (34%), dyspnea (33%), increased potassium (31%), decreased leukocytes (30%), headache (29%), increased alkaline phosphatase (25%), dizziness (26%) and nausea (25%). Drug Interactions Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended. Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding. Lactation Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose. Females and Males of Reproductive Potential WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG. Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose. Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown. Pediatric Use Use of WELIREG in pediatric patients aged 12 years and older is supported by evidence from an adequate and well-controlled study of WELIREG in adults with additional pharmacokinetic data demonstrating that belzutifan exposure is predicted to be within range of that observed in adults, and that the course of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma is sufficiently similar in adults and pediatric patients to allow extrapolation of data in adults to pediatric patients. The safety and effectiveness of WELIREG have not been established in patients with VHL or ccRCC, or in pediatric patients younger than 12 years of age with PPGL. Renal Impairment For patients with severe renal impairment (eGFR 15-29 mL/min estimated by MDRD), monitor for increased adverse reactions and modify the dosage as recommended. Hepatic Impairment For patients with moderate and severe hepatic impairment, monitor for increased adverse reactions and modify the dosage as recommended. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Renal Cell Carcinoma KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with axitinib, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA and KEYTRUDA QLEX are each indicated for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with WELIREG, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. See additional selected KEYTRUDA and KEYTRUDA QLEX indications in the U.S. after the Selected Safety Information. Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX Contraindications KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Merck Animal Health to Acquire TARGANJune 11, 2026 6:45 AM
Business Wire TARGAN’s innovative high-speed biodevice technology, including its gender identification product WingScan™, delivers enhanced poultry performance Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that it has signed a definitive agreement to acquire TARGAN, a privately held innovator in developing and commercializing biodevice solutions to improve performance outcomes for the poultry industry, for an undisclosed purchase price. Merck Animal Health has invested in TARGAN since 2017 and has been one of the company’s largest shareholders. The proposed acquisition is expected to be completed in the third quarter of 2026, subject to approvals from applicable regulatory authorities and other customary closing conditions. “The acquisition of TARGAN’s best-in-class biodevice technology for use in commercial hatcheries complements and accelerates our growing biopharmaceutical presence in poultry and increases our ability to deliver significant customer value globally,” said Rick DeLuca, president, Merck Animal Health. “Additionally, TARGAN brings device development capabilities that will further strengthen our ability to provide animal health solutions across species. This transaction, coupled with our commercial and scientific expertise, is another example of how we deliver meaningful innovation to our customers while creating new opportunities for the future.” Upon closing, the acquisition is expected to broaden Merck Animal Health’s portfolio in commercial poultry operations with WingScan™, an automated solution that uses vision technology to identify and sort chicks by gender, processing up to 160,000 chicks per hour. The technology, which can scale to any size hatchery operation, captures high-resolution images of each chick’s feathers and analyzes them in real-time using advanced engineering capabilities and proprietary algorithms. This acquisition also brings the capability for a high-speed precision ocular spray technology, which administers respiratory and coccidiosis vaccines, among others, to day-old chicks. Additionally, TARGAN has the potential to develop additional biodevices within poultry and other livestock species, which may shape the next frontier in the animal health industry. TARGAN Founder and CEO Ramin Karimpour said, “Merck Animal Health has been a foundational partner of TARGAN since our inception through its belief and commitment to scientific excellence and a common goal of bringing technological innovation to the livestock industry. Through this proposed acquisition, TARGAN will be able to access resources and infrastructure of Merck Animal Health, which will be critical in deploying TARGAN’s innovative biodevice technology along with their broad portfolio of poultry vaccines for customers. Many colleagues over the years have made valuable contributions to the growth of our business, including our employees, venture capital investors and debt finance providers.” About TARGAN
TARGAN is an innovative animal AgTech systems company focused on transforming animal protein production industries worldwide. Founded in 2015 and based in Raleigh, North Carolina, the company's mission is to provide affordable, individualized technologies that will improve speed, accuracy and animal welfare. For more information, visit TARGAN.com. About Merck Animal Health
Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260610672968/en/ Media Contacts:
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peter.dannenbaum@merck.com Original: Merck Animal Health to Acquire TARGAN

Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 StudyJune 8, 2026 4:30 PM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study investigating Gilead’s Trodelvy® (sacituzumab govitecan-hziy) in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, compared to KEYTRUDA monotherapy in certain patients with previously untreated metastatic non-small cell lung cancer, whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%). The decision is based on the recommendation from the external Data Monitoring Committee (eDMC) following their review of the data from the pre-specified final analysis of progression-free survival (PFS) and interim analysis of overall survival (OS). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608789974/en/ A numerical improvement in PFS was observed, but did not reach statistical significance. The probability of achieving statistically significant OS is unlikely at the planned final analysis. The safety profile of Trodelvy in combination with KEYTRUDA was consistent with the known safety of each agent. No new safety signals were identified with the combination. These data will be presented at a future medical meeting. Regulatory authorities have been informed. Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. There are no changes to ongoing Trodelvy or Merck studies. The companies are grateful to the patients, families, and healthcare professionals who participated in the KEYNOTE-D46/EVOKE-03 study and contributed to this important work. Trodelvy is a registered trademark of Gilead Sciences, Inc., or its related companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Metastatic Non-Small Cell Lung Cancer Lung cancer is one of the most common cancers worldwide, with an estimated 2.5 million new cases reported globally in 2022. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of lung cancers, and nearly half of these NSCLC patients are diagnosed only after the disease has spread, when treatment options are more limited and long-term survival remains low. Despite treatment advances, the 5-year survival rate for metastatic NSCLC is less than 10%. While immunotherapy, with or without chemotherapy, is a standard first treatment option, it does not work for everyone, and new treatment options are needed. About KEYNOTE-D46/EVOKE-03 The KEYNOTE-D46/EVOKE-03 study is a global, open-label, randomized Phase 3 trial, sponsored by Merck, evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) in combination with KEYTRUDA (pembrolizumab) compared with KEYTRUDA monotherapy in patients with previously untreated metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and do not have sensitizing EGFR, ALK or ROS1 genomic alterations. Approximately 620 patients were enrolled across study sites worldwide. Patients were randomized 1:1 to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) plus KEYTRUDA (200 mg intravenously on Day 1 of a 21-day cycle), or KEYTRUDA monotherapy (200 mg intravenously on Day 1 of a 21-day cycle). KEYTRUDA was administered for up to 35 cycles, and Trodelvy was continued until disease progression, death, unacceptable toxicity or another treatment discontinuation criterion was met. The dual primary endpoints of the study are progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), patient-reported outcomes (PROs) and safety. More information about the study is available at ClinicalTrials.gov: NCT05609968. About Trodelvy Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Healthcare professionals have well-established experience with Trodelvy, which has shown generally consistent outcomes across both clinical trials and real-world use in more than 75,000 breast cancer patients across 60+ countries. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in small cell lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. Indications for Trodelvy TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. Important safety information FOR TRODELVY BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV TreatmentJune 8, 2026 4:35 PM
Business Wire – Novel Investigational Combination Pairs Merck’s Islatravir, a Next-Generation Nucleoside Analog with Distinct Mechanisms of Action, Including Reverse Transcriptase Translocation Inhibition, with Gilead’s Lenacapavir, a First-in-Class Capsid Inhibitor that Disrupts HIV at Multiple Stages of its Lifecycle – – Islatravir/Lenacapavir has the Potential to be the First Approved Long-Acting Oral HIV Treatment Taken Once-Weekly – Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. Gilead and Merck plan to file the Phase 3 data from the ISLEND trials with regulatory authorities globally and submit the detailed findings for presentation at a future scientific congress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608276598/en/ “Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.” The primary efficacy endpoint of ISLEND-1 and ISLEND-2 was the percentage of participants with HIV-1 RNA levels ≥ 50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the double-blind ISLEND-1 trial, the once-weekly, single-tablet regimen of ISL/LEN was found to be statistically non-inferior to BIKTARVY. In the open-label ISLEND-2 trial, ISL/LEN was found to be statistically non-inferior to standard of care daily oral antiretroviral therapy regimens. The safety profile of ISL/LEN was generally comparable to BIKTARVY in ISLEND-1 and to standard of care antiretroviral regimens in ISLEND-2. “These results underscore the shared focus and commitment that we and our collaborators at Gilead have on continuing research to help people living with HIV. By advancing this investigational novel once-weekly oral regimen of islatravir and lenacapavir, we aim to bring forward a new long-acting oral option that, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. The combination of islatravir and lenacapavir targets multiple stages of HIV-1 replication, potentially offering people with HIV who are virologically suppressed a novel, long-acting oral single-tablet regimen. The potency and pharmacokinetic profiles of islatravir and lenacapavir enable long-acting dosing as a once-weekly tablet for HIV treatment, if approved. Islatravir and lenacapavir in combination are investigational and not approved for use. There is currently no cure for HIV or AIDS. About ISLEND-1 ISLEND-1 (NCT06630286) is a Gilead-sponsored, multicenter Phase 3 randomized, double-blind, active-controlled trialdesigned to evaluate the safety and efficacy of switching to a once-weekly tablet of islatravir/lenacapavir (ISL/LEN) versus continuing treatment with BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on BIKTARVY for ≥ 6 months prior to screening. Participants were randomized 1:1 to receive initial doses of ISL/LEN on Day 1 and Day 2 followed by once-weekly ISL/LEN from Day 8 to Week 96 plus placebo-to-match BIKTARVY daily, or BIKTARVY daily plus placebo-to-match initial doses of ISL/LEN on Day 1 and Day 2 and placebo-to-match once-weekly ISL/LEN from Day 8 to Week 96. The primary endpoint was the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48, as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events. About ISLEND-2 ISLEND-2 (NCT06630299) is a Gilead-sponsored, multicenter Phase 3 randomized, open-label, active-controlled trialevaluating the safety and efficacy of switching to a once-weekly tablet of ISL/LEN versus continuation of standard of care treatment in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care antiretroviral regimen for ≥ 6 months prior to screening. A standard of care regimen included two or three antiretroviral medicines, including integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTIs), boosted protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI). Participants either received an initial dose of ISL/LEN followed by once-weekly ISL/LEN from Day 8 to Week 96, or continued their standard of care treatment with two/three antiretroviral medicines up to Week 96. The primary endpoint is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 by FDA-defined Snapshot Algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events. About Lenacapavir The multi-stage mechanism of action of lenacapavir is distinguishable from other approved classes of antiretroviral agents. While most antiretrovirals act on one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known exhibited cross-resistance in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV treatment and prevention research program. Lenacapavir is being developed as a foundation for potential future HIV therapies to offer both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono-agent, that help address the individual needs and preferences of people and communities affected by HIV. For an overview of Gilead’s HIV treatment and prevention clinical development program, please click here. About Islatravir (MK-8591) Islatravir (MK-8591) is Merck’s potent, next-generation nucleoside analog that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Islatravir is anchoring multiple ongoing early and late-stage clinical trials of two-drug regimens in combination with other Merck antiretrovirals for potential treatments for HIV-1. Islatravir is being studied in Phase 3 in combination with Merck’s doravirine (DOR/ISL) as a once-daily pill for treatment of HIV-1 infection in adults with no prior antiviral treatment history and in Phase 2b in combination with Merck’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) as an oral once-weekly treatment for HIV-1. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here. About Gilead HIV For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Merck’s Commitment to HIV For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Gilead Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving lenacapavir (such as ISLEND-1 and ISLEND-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, such as oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). BIKTARVY, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs. View source version on businesswire.com: https://www.businesswire.com/news/home/20260608276598/en/ GILEAD CONTACTS:
Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com MERCK CONTACTS:
Melissa Moody, Media
mediarelations@merck.com Damini Chokshi, Investors
investor_relations@merck.com Original: Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment

Tech Sector Pressure Points to Lower Start for Wall Street: Dow Jones, S&P, Nasdaq, FuturesJune 5, 2026 9:16 AM
IH Market News U.S. stock futures indicated a weaker opening on Friday, with technology stocks expected to remain under pressure following renewed concerns over valuations and growth expectations in the semiconductor sector. The negative tone was particularly evident in Nasdaq 100 futures, which declined 1.3%, signaling potential weakness among large-cap technology names at the opening bell. Chip Stocks Continue to Weigh on Sentiment Selling pressure in semiconductor stocks remained a key focus after investors reacted negatively to Broadcom’s (NASDAQ:AVGO) latest outlook. Although the company delivered quarterly results ahead of expectations, its guidance failed to satisfy investors accustomed to increasingly ambitious projections tied to artificial intelligence demand. Daniela Hathorn, Senior Market Analyst at Capital.com, said: “The market is no longer asking whether AI demand is strong, that has largely been established.” She added: “Instead, investors are beginning to question how much of that growth is already reflected in valuations.” According to Hathorn, “In that sense, Broadcom’s results may not have been disappointing, but they were perhaps not enough to justify another leg higher immediately after such a powerful rally.” Strong Jobs Data Raises Interest Rate Concerns Futures extended their losses after the release of the latest U.S. employment report, which showed job creation significantly exceeding market expectations in May. The Labor Department reported that nonfarm payrolls increased by 172,000 positions during the month, following an upwardly revised gain of 179,000 jobs in April. Economists had forecast an increase of 85,000 jobs, compared with the originally reported gain of 115,000 in the prior month. The stronger-than-expected labor market data pushed Treasury yields higher as investors reassessed the likelihood that the Federal Reserve could maintain elevated interest rates for longer than previously anticipated. Dow Reaches New Record Despite Tech Weakness Despite technology sector headwinds, U.S. equities finished mostly higher on Thursday. The Dow Jones Industrial Average led the gains, rising 874.86 points, or 1.7%, to close at a record 51,561.93. The S&P 500 advanced 30.63 points, or 0.4%, ending at 7,584.31. Meanwhile, the Nasdaq Composite lagged behind its peers, slipping 23.02 points, or 0.1%, to finish at 26,830.98. UnitedHealth Drives Dow Higher A major contributor to the Dow’s strong performance was UnitedHealth (NYSE:UNH), whose shares jumped 5.2%. The rally followed an upgrade from Bank of America, which raised its recommendation on the health insurer to Buy from Neutral. Other Dow components also posted solid gains, including American Express (NYSE:AXP), Goldman Sachs (NYSE:GS) and Merck (NYSE:MRK). Broadcom Sell-Off Hits Technology Stocks Technology shares remained under pressure throughout Thursday’s session, largely because of Broadcom’s sharp decline. The semiconductor company fell 12.6% despite reporting fiscal second-quarter earnings that exceeded analyst forecasts. Investors appeared disappointed that Chief Executive Officer Hock Tan did not increase the company’s projection for annual AI-related chip sales, which remains at $100 billion. AJ Bell Head of Markets Dan Coatsworth commented: “Broadcom may have emerged as a key player in the booming AI infrastructure market, with a particular expertise in the custom chips increasingly being used by the likes of Alphabet and Meta.” He added: “However, just like its rival Nvidia, Broadcom is finding that meeting and even slightly beating forecasts is not enough when the market is holding it to such a high standard.” Financial and Healthcare Shares Outperform While technology struggled, several other sectors posted strong gains. Banking stocks rallied sharply, lifting the KBW Bank Index by 3.7% to its highest closing level in nearly four months. Healthcare and pharmaceutical shares also performed strongly, with the NYSE Arca Pharmaceutical Index rising 3.5% and the Dow Jones U.S. Health Care Index advancing 3%. Brokerage firms, biotechnology companies and commercial real estate stocks also finished higher, helping offset weakness in semiconductor and computer hardware shares. Broadcom stock price UnitedHealth Group stock price American Express stock price Goldman Sachs Group stock price Merck stock price Original: Tech Sector Pressure Points to Lower Start for Wall Street: Dow Jones, S&P, Nasdaq, Futures

Merck to Participate in the Goldman Sachs 47th Annual Global Healthcare ConferenceJune 2, 2026 6:45 AM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026, at 11:20 a.m. ET. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink. About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).  View source version on businesswire.com: https://www.businesswire.com/news/home/20260602290094/en/ Media Contacts: John Cummins
john.cummins2@merck.com Michael Levey
michael.levey @Edwin48 Damini Chokshi
(732) 594-1577 Original: Merck to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference

Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA (pembrolizumab) in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at the 2026 ASCO Annual MeetingJune 1, 2026 8:00 AM
ACCESS NewswireAt a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA aloneIntismeran autogene in combination with KEYTRUDA demonstrated an encouraging trend toward overall survival in an exploratory analysis compared to KEYTRUDA alone (HR=0.471; [95% CI, 0.165-1.345])CAMBRIDGE, MA AND RAHWAY, NJ / ACCESS Newswire / June 1, 2026 / Moderna, Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced detailed results from a planned five-year follow-up analysis of the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with high-risk melanoma (stage III/IV) following complete resection. These data will be presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2) and published simultaneously in ASCO's Journal of Clinical Oncology.With a median follow-up of 60.3 months (range, 50.5-76.4), adjuvant treatment with intismeran autogene in combination with KEYTRUDA continued to prolong recurrence-free survival (RFS), the study's primary endpoint, reducing the risk of recurrence or death by 49% (HR=0.51; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, reducing the risk of distant metastasis or death by 59% (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone. The exploratory endpoint of overall survival (OS) also demonstrated an encouraging trend toward improved OS (HR=0.471; [95% CI, 0.165-1.345]; n=14) with intismeran autogene in combination with KEYTRUDA compared to KEYTRUDA alone. Together, these findings indicate a sustained improvement in RFS and DMFS at five years."With each year of continued follow-up of our Phase 2b study, we gain a more complete picture of the durability of intismeran autogene in combination with KEYTRUDA. Now, with a median follow-up of five years, the sustained recurrence-free survival and distant metastasis-free survival demonstrate the potential long-term benefit of intismeran autogene in combination with KEYTRUDA in melanoma patients at high risk of recurrence," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "These findings add to our confidence in the potentially transformative impact of this novel, personalized approach to cancer care made possible by mRNA technology.""The risk of disease recurrence remains high for patients with stage III/IV melanoma following surgery, so we are encouraged by these long-term findings showing that intismeran autogene in combination with KEYTRUDA provided sustained and durable reductions in the risk of recurrence," said Dr. Majorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "These data further reinforce the potential of this individualized approach to address critical gaps in the adjuvant setting and reflect our continued commitment to advancing innovative therapies for patients."The safety profile of intismeran autogene in combination with KEYTRUDA remained consistent with prior analyses. The most common adverse events attributed to intismeran autogene in combination with KEYTRUDA were fatigue (59.6%), injection site pain (59.6%), and chills (51.0%). The majority of the adverse events attributed to intismeran autogene were Grade 1 (31.7%) and Grade 2 (51.9%), with fatigue being the most common Grade 3 event (4.8%) and no Grade 4-5 events. Immune-related adverse events occurred in 45.2% of patients receiving the combination and 44% receiving KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA did not result in potentiation of immune-related AEs.The findings build on the primary analysis and supportive analysis at an approximately three-year follow-up (34.9 months), presented at the 2024 ASCO Annual Meeting, in which intismeran autogene in combination with KEYTRUDA resulted in a 49% RFS risk reduction and 62% DMFS risk reduction compared to KEYTUDA alone.Additional subgroup and translational dataData from an exploratory subgroup analysis continued to indicate that improvement in RFS was maintained with intismeran autogene in combination with KEYTRUDA across subpopulations, including age, sex, disease state (Stage III/IV), programmed death-ligand 1 (PD-L1) status, BRAF status, tumor mutation burden (TMB) or circulating tumor DNA (ctDNA) status, compared to KEYTRUDA alone.Intismeran autogene plus KEYTRUDA increased T-cell clonal expansion and promoted the emergence of new T-cell clonotypes compared with KEYTRUDA alone. At long-term follow-up, patients receiving the combination demonstrated an approximately 2-fold higher proportion of novel expanded T-cell clonotypes versus KEYTRUDA monotherapy (0.030 vs 0.016 median summed frequency). Higher magnitude increases of these novel T-cell clones was associated with remaining recurrence-free; recurrence-free patients in the combination arm had approximately twice the number of unique novel expanded clonotypes at long-term follow-up (median number 42 vs 20 in recurrence-free vs recurrence patients, respectively). Additional data presented at ASCO (abstract #9564) found that, in a subset of melanoma patients receiving adjuvant combination therapy, these novel clonotypes were linked to intismeran-encoded neoantigens, supporting intismeran's proposed mechanism of action and association with clinical benefit.[1]Ongoing clinical development programsModerna and Merck have nine total Phase 2 and Phase 3 clinical trials underway investigating intismeran autogene in combination with KEYTRUDA across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran autogene as a monotherapy and in combination with KEYTRUDA for the treatment of high-risk Stage I NSCLC (INTerpath-014, NCT07513376).The Phase 3 clinical trial for adjuvant melanoma (INTerpath-001, NCT05933577) and a randomized Phase 2 study for adjuvant renal cell carcinoma (INTerpath-004, NCT06307431) are fully enrolled. Two NSCLC Phase 3 studies, evaluating adjuvant treatment in patients with completely resected NSCLC (INTerpath-002, NCT06077760) and evaluating adjuvant treatment for patients with resectable NSCLC after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy (INTerpath-009, NCT06623422), are enrolling. Randomized Phase 2 studies for patients with resected muscle invasive bladder cancer (INTerpath-005, NCT06305767) and resected non-muscle invasive bladder cancer (INTerpath-011, NCT06833073) are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma (INTerpath-012, NCT06961006) and a Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC (INTerpath-013, NCT07221474) are also enrolling.About intismeran autogene (mRNA-4157 or V940)Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient's tumor.About KEYNOTE-942/mRNA-4157-P201 (NCT03897881)KEYNOTE-942 is an ongoing randomized, open-label Phase 2b trial that enrolled 157 patients with high-risk stage III/IV melanoma. Following complete surgical resection, patients were assigned 2:1 (stratified by stage) to receive intismeran autogene (1 mg every three weeks for nine doses) and KEYTRUDA (200 mg every three weeks up to 18 cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity. The primary endpoint is RFS, defined as the time from first dose of KEYTRUDA until the date of first recurrence (local, regional or distant metastasis), a new primary melanoma, or death from any cause in the intention-to-treat population. Secondary endpoints include distant metastasis-free survival and safety, and exploratory endpoints include distribution of TMB expression in baseline tumor samples across study arms and their association with the primary RFS endpoint.Key eligibility criteria for the trial included: patients with resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence, patients with complete resection within 13 weeks prior to the first dose of KEYTRUDA, patients were disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases, patients had a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 and patients with normal organ and marrow function reported at screening.About melanomaMelanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026.About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mgKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.MelanomaKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.Selected Important Safety Information for KEYTRUDASevere and Fatal Immune-Mediated Adverse ReactionsKEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti-PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.Immune-Mediated PneumonitisKEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.Immune-Mediated ColitisKEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)May 29, 2026 6:45 AM
Business Wire First Breakthrough Therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial Calderasib is an investigational, highly potent and specific next-generation KRAS G12C covalent inhibitor Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%). This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase 1 KANDLELIT-001 trial. “As our understanding of cancer biology and precision medicine continues to advance, we’re encouraged by the potential of new approaches, like calderasib, to help address the underlying drivers of cancer growth,” said Dr. Shweta Jain, vice president, global clinical development, Merck Research Laboratories. “The Breakthrough Therapy designation for calderasib underscores the promising potential of this medicine and unmet need for certain patients with KRAS G12C-mutated NSCLC.” The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of patients with NSCLC (adenocarcinoma). The FDA’s Breakthrough Therapy designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must indicate that the product may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. The benefits of this Breakthrough Therapy designation include more intensive guidance from the FDA on an efficient development program, organizational commitment involving senior managers and experienced review staff, rolling review and potential eligibility for Priority Review. The KANDLELIT clinical development program for calderasib includes five Phase 3 trials across a range of tumor types and stages, including: KANDLELIT-004, evaluating calderasib in combination with KEYTRUDA for patients with newly diagnosed metastatic NSCLC with KRAS G12C-mutation and PD-L1 TPS ≥50%. KANDLELIT-007, evaluating calderasib in combination with KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in patients with newly diagnosed advanced or metastatic nonsquamous NSCLC with KRAS G12C-mutation, regardless of PD-L1 expression. KANDLELIT-012, evaluating calderasib in combination with cetuximab and mFOLFOX6 for the first-line treatment of certain patients with locally advanced unresectable or metastatic CRC who have KRAS G12C-mutated tumors. KANDLELIT-013, evaluating calderasib in combination with KEYTRUDA QLEX for certain patients with locally advanced KRAS G12C-mutated NSCLC following receipt of either neoadjuvant KEYTRUDA plus chemotherapy or adjuvant chemotherapy. KANDLELIT-015, evaluating calderasib in combination with durvalumab in certain patients with locally advanced, KRAS G12C-mutated NSCLC after chemotherapy and radiation therapy. Calderasib is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd. and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. This collaboration was announced in January 2020. About calderasib
Calderasib (MK-1084) is an investigational, highly potent and specific next-generation KRAS G12C covalent inhibitor. Mutations in KRAS are among the most prevalent mutations found in cancer, occurring with high frequency in non-small cell lung cancer (NSCLC), pancreatic, urogenital and colorectal cancers. The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of patients with NSCLC (adenocarcinoma). Despite decades of research and recognition of the therapeutic importance of targeting KRAS, the development of small molecule inhibitors targeting KRAS mutations has been challenging. About lung cancer
Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In 2025, the overall five-year survival rate for patients diagnosed with lung cancer was nearly 30% in the United States. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 43% of lung cancer cases are not found until they are advanced. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL
KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). Selected KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA or KEYTRUDA QLEX. KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Colorectal Cancer KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX Contraindications KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Merck to Participate in the Jefferies Global Healthcare ConferenceMay 28, 2026 6:45 AM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, is scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 4, 2026, at 10:30 a.m. ET. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink. About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260528272528/en/ Media Contacts: John Cummins
john.cummins2@merck.com Michael Levey
michael.levey @Edwin48 Steven Graziano
(732) 594-1583 Original: Merck to Participate in the Jefferies Global Healthcare Conference

Merck Announces Third-Quarter 2026 DividendMay 26, 2026 1:28 PM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Board of Directors has declared a quarterly dividend of $0.85 per share of the company’s common stock for the third quarter of 2026. Payment will be made on July 8, 2026, to shareholders of record at the close of business on June 15, 2026. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260526058758/en/ Media Contacts: John Cummins
john.cummins2@merck.com Michael Levey
michael.levey@merck.com Investor Contacts: Peter Dannenbaum
(732) 594-1579 Steven Graziano
(732) 594-1583 Original: Merck Announces Third-Quarter 2026 Dividend

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder CancerMay 22, 2026 7:55 AM
Business Wire Opinion granted based on positive event-free survival, overall survival and pathologic complete response rate results from the Phase 3 KEYNOTE-905 trial If approved, this combination would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for this patient population in the European Union Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This recommendation, which also includes KEYTRUDA SC® [known as KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected by the third quarter of 2026. “Patients in Europe with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy have limited treatment options and are at high risk for disease recurrence,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “This positive CHMP recommendation brings us closer to a new chapter of patient care – one that could address this significant unmet need by offering a KEYTRUDA-based regimen both before and after surgery, based on the compelling results from KEYNOTE-905.” The recommendation is based on results from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. The KEYTRUDA plus Padcev regimen reduced the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p

Synergis Software lance Adept Cloud, une plateforme de gestion de documents d'ingénierie native du nuage conçue pour les industries à forte intensité d'actifsMay 21, 2026 1:42 PM
PR Newswire (Canada) La plateforme primée Adept, maintenant offerte sous forme de solution SaaS entièrement gérée, avec des capacités d'IA intégréesQUAKERTOWN, Pennsylvanie, 21 mai 2026 /CNW/ - Synergis Software a annoncé la disponibilité générale d'Adept Cloud, une plateforme infonuagique de gestion de documents d'ingénierie SaaS conçue pour les entreprises du secteur manufacturier, des services publics, du pétrole et du gaz, des produits chimiques, des produits pharmaceutiques et de l'exploitation minière, où l'exactitude de la documentation d'ingénierie est une question de sécurité opérationnelle, de conformité réglementaire et de résultats de projet. Adept Cloud offre toutes les capacités de la plateforme primée Adept dans un environnement basé sur un navigateur hébergé, entretenu et mis à jour en continu par Synergis. Aucune infrastructure locale, aucun VPN ni frais généraux de TI n'est requis.« Nous avons créé Adept Cloud parce que nos clients nous ont dit où ils devaient aller, et nous nous sommes engagés à les y conduire. Ce que nous avons construit n'est pas seulement une version nuagique d'Adept. Il s'agit d'une plateforme infonuagique moderne conçue pour la sécurité, la fiabilité et l'extensibilité dont les entreprises à forte intensité d'actifs ont besoin pour la décennie à venir. Adept Cloud est également le lieu où nous continuerons d'innover : l'intelligence artificielle est intégrée, d'autres fonctionnalités suivront. Et au fur et à mesure que cette plateforme évoluera, elle servira également de base aux déploiements sur site, en veillant à ce que chaque client Adept ait accès aux mêmes capacités, quelle que soit la façon dont il choisit de déployer. Voilà ce que signifie atteindre ce jalon pour nous. Il s'agit d'une étape importante pour Synergis, et nos clients obtiennent une plateforme avec laquelle ils peuvent évoluer pour les années à venir. »— Kristen Tomasic, présidente, Synergis SoftwareApprenez-en davantage sur Adept Cloud.Conçu pour les entreprises qui ne peuvent pas se permettre de se tromperDans les secteurs à actifs élevés, la mauvaise révision de document n'est pas seulement un inconvénient : il s'agit d'un risque pour la sécurité, d'un manquement à la conformité, d'un ordre de changement coûteux et d'un retard dans les projets. Adept Cloud est conçu pour des environnements où la précision compte, offrant un accès rapide aux bons documents, une intégration CAO, une protection de la propriété intellectuelle et une traçabilité à chaque décision.« La question que nous entendons le plus souvent des sociétés d'ingénierie était de savoir si un EDMS infonuagique pouvait vraiment gérer la complexité de leurs activités. Les relations CAO, les flux de travail contrôlés, les exigences d'audit, l'échelle. Adept Cloud a été conçu pour répondre à cette question en toute confiance. La réponse est oui. » — Todd Cummings, vice-président, stratégie des produits, Synergis SoftwareUtilisateurs illimités. Aucun coût par siège.Chaque forfait Adept Cloud (Essentials, Professional et Enterprise) comprend un nombre illimité d'utilisateurs. Aucun coût par siège et aucune limite quant aux personnes qui peuvent accéder au système, qu'il s'agisse d'ingénieurs à leur bureau ou d'équipes sur le terrain ou sur le plancher de l'usine.Synergis tiendra un webinaire Adept Cloud pour les clients le 4 juin et un webinaire de présentation Adept Cloud ouvert à toutes les entreprises intéressées le 17 juin.Adept AI : l'intelligence où vivent vos données d'ingénierieAdept AI est conçu pour la plateforme Adept Cloud - des capacités d'intelligence artificielle qui aident les entreprises d'ingénierie à extraire l'information plus rapidement, à accélérer le travail exigeant des documents et à générer davantage de valeur des données d'ingénierie déjà présentes dans leur système.« L'information d'ingénierie est l'un des actifs les plus précieux et sous-utilisés de toute organisation industrielle — contexte critique enfoui dans des dizaines ou des centaines de milliers de documents, largement inaccessibles. Adept AI change cela en mettant l'intelligence au service de la couche plateforme - à l'intérieur du système où vivent déjà les données, avec la gouvernance et la sécurité dont les industries à actifs importants ont besoin. »— Scott Lamond, vice-président, marketing, Synergis SoftwarePremiers pas avec Adept CloudAdept Cloud est disponible dès aujourd'hui. Les nouveaux clients travaillent avec leur gestionnaire de la réussite client dédié via un plan d'intégration qui s'harmonise avec leur Adept Cloud Plan et rationalise le délai de rentabilité. Les clients actuels d'Adept peuvent passer à Adept Cloud grâce à un plan personnalisé conçu pour minimiser les perturbations et maximiser la continuité.Reconnaissance et confiance des clientsSynergis Adept a été nommée meilleure plateforme de gestion des documents d'ingénierie aux Best Software Awards 2026 de G2. La plateforme détient les distinctions G2 pour le meilleur soutien, la meilleure relation et la plus grande adoption par les utilisateurs, et 95 % des avis G2 vérifiés sont évalués à quatre ou cinq étoiles.À propos de Synergis SoftwareSynergis Software est le créateur d'Adept, une plateforme de gestion de documents d'ingénierie de premier plan reconnue par des entreprises mondiales comme Dow, Con Edison, Merck et General Mills. La société a été nommée meilleure plateforme de gestion de documents d'ingénierie par G2 en 2026. Depuis plus de 35 ans, Synergis aide les industries à forte intensité d'actifs, y compris la fabrication, les produits chimiques, les services publics, le pétrole et le gaz, les sciences de la vie et l'exploitation minière, à centraliser, à régir et à exploiter l'information sur l'ingénierie pour accélérer les projets, renforcer la conformité et réduire les risques opérationnels. Adept est offert en tant que plateforme SaaS entièrement gérée et en tant que solution sur site.Pour en savoir plus, visitez SynergisSoftware.com.PERSONNE-RESSOURCE POUR LES MÉDIAS
Scott Lamond
Vice-président, marketing, Synergis Software
scott.lamond@synergis.com   Photo - https://mma.prnewswire.com/media/2983727/Adept_Cloud_On_Light.jpg
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Synergis Software Launches Adept Cloud, a Cloud-Native Engineering Document Management Platform Built for Asset-Intensive IndustriesMay 21, 2026 6:02 AM
PR Newswire (US) The award-winning Adept platform, now delivered as a fully managed SaaS solution — with AI capabilities built inQUAKERTOWN, Pa., May 21, 2026 /PRNewswire/ -- Synergis Software announced the general availability of Adept Cloud, a cloud-native SaaS engineering document management platform built for organizations in manufacturing, utilities, oil and gas, chemicals, pharmaceuticals, and mining — where the accuracy of engineering documentation is a matter of operational safety, regulatory compliance, and project outcomes. Adept Cloud delivers the full capabilities of the award-winning Adept platform in a browser-based environment that is hosted, maintained, and continuously updated by Synergis — no local infrastructure, no VPN, and no IT overhead required. "We built Adept Cloud because our customers told us where they needed to go — and we made a commitment to get them there. What we built isn't just a cloud version of Adept. It's a modern, cloud-native platform — architected for the security, reliability, and scalability that asset-intensive organizations require for the decade ahead. Adept Cloud is also where we'll continue to innovate — AI is built in, with more to come. And as this platform evolves, it will serve as the foundation for on-premise deployments as well, ensuring every Adept customer has access to the same capabilities, regardless of how they choose to deploy. That's what reaching this moment means to us — it's a milestone for Synergis, and our customers get a platform they can grow with for years to come."— Kristen Tomasic, President, Synergis SoftwareLearn more about Adept Cloud.Built for the Organizations That Can't Afford to Get It WrongIn asset-intensive industries, the wrong document revision isn't just an inconvenience — it is a safety risk, a compliance failure, an expensive change order, and a project delay. Adept Cloud is built for environments where precision matters — delivering fast access to the right documents, CAD integration, intellectual property protection, and traceability across every decision."The question we heard most from engineering organizations was whether a cloud EDMS could really handle the complexity of what they do. The CAD relationships, the controlled workflows, the audit requirements, the scale. Adept Cloud was built to answer that question with confidence. The answer is yes." — Todd Cummings, Vice President of Product Strategy, Synergis SoftwareUnlimited Users. No Per-Seat Costs.Every Adept Cloud plan — Essentials, Professional, and Enterprise — includes unlimited users. No per-seat costs, and no limits on who can access the system, from engineers at their desks to teams in the field or on the plant floor.Synergis will host an Adept Cloud webinar for customers on June 4, and an Adept Cloud introduction webinar open to all interested organizations on June 17.Adept AI: Intelligence Where Your Engineering Data LivesAdept AI is built for the Adept Cloud platform — artificial intelligence capabilities that help engineering organizations surface information faster, accelerate document-intensive work, and extract more value from the engineering data already in their system."Engineering information is one of the most valuable and underutilized assets in any industrial organization — critical context buried within tens or hundreds of thousands of documents, largely inaccessible. Adept AI changes that by putting intelligence to work at the platform layer — inside the system where the data already lives, with the governance and security that asset-intensive industries require."— Scott Lamond, Vice President of Marketing, Synergis SoftwareGetting Started with Adept CloudAdept Cloud is available today. New customers work with their dedicated customer success manager through an onboarding plan that aligns with their Adept Cloud Plan and streamlines time to value. Existing Adept customers can transition to Adept Cloud through a personalized plan designed to minimize disruption and maximize continuity.Recognition and Customer TrustSynergis Adept was named to G2's 2026 Best Software Awards as the top-ranked engineering document management platform. The platform holds G2 distinctions for Best Support, Best Relationship, and Highest User Adoption. 95% of verified G2 reviews are rated four or five stars.About Synergis SoftwareSynergis Software is the creator of Adept, a leading engineering document management platform trusted by global organizations including Dow, Con Edison, Merck, and General Mills — and named to G2's 2026 Best Software Awards as the top-ranked engineering document management platform. For more than 35 years, Synergis has helped asset-intensive industries — including manufacturing, chemicals, utilities, oil and gas, life sciences, and mining — centralize, govern, and leverage engineering information to accelerate projects, strengthen compliance, and reduce operational risk. Adept is available both as a fully managed SaaS platform and as an on-premise solution.For more information, visit SynergisSoftware.com.MEDIA CONTACT
Scott Lamond
Vice President of Marketing, Synergis Software
scott.lamond@synergis.com   Photo - https://mma.prnewswire.com/media/2983727/Adept_Cloud_On_Light.jpg
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Synergis Software Launches Adept Cloud, a Cloud-Native Engineering Document Management Platform Built for Asset-Intensive IndustriesMay 20, 2026 11:02 AM
PR Newswire (Canada) The award-winning Adept platform, now delivered as a fully managed SaaS solution — with AI capabilities built inQUAKERTOWN, Pa., May 20, 2026 /CNW/ -- Synergis Software announced the general availability of Adept Cloud, a cloud-native SaaS engineering document management platform built for organizations in manufacturing, utilities, oil and gas, chemicals, pharmaceuticals, and mining — where the accuracy of engineering documentation is a matter of operational safety, regulatory compliance, and project outcomes. Adept Cloud delivers the full capabilities of the award-winning Adept platform in a browser-based environment that is hosted, maintained, and continuously updated by Synergis — no local infrastructure, no VPN, and no IT overhead required. Adept Cloud — a fully managed, cloud-native SaaS engineering document management system is now generally available."We built Adept Cloud because our customers told us where they needed to go — and we made a commitment to get them there. What we built isn't just a cloud version of Adept. It's a modern, cloud-native platform — architected for the security, reliability, and scalability that asset-intensive organizations require for the decade ahead. Adept Cloud is also where we'll continue to innovate — AI is built in, with more to come. And as this platform evolves, it will serve as the foundation for on-premise deployments as well, ensuring every Adept customer has access to the same capabilities, regardless of how they choose to deploy. That's what reaching this moment means to us — it's a milestone for Synergis, and our customers get a platform they can grow with for years to come."— Kristen Tomasic, President, Synergis SoftwareLearn more about Adept Cloud.Built for the Organizations That Can't Afford to Get It WrongIn asset-intensive industries, the wrong document revision isn't just an inconvenience — it is a safety risk, a compliance failure, an expensive change order, and a project delay. Adept Cloud is built for environments where precision matters — delivering fast access to the right documents, CAD integration, intellectual property protection, and traceability across every decision."The question we heard most from engineering organizations was whether a cloud EDMS could really handle the complexity of what they do. The CAD relationships, the controlled workflows, the audit requirements, the scale. Adept Cloud was built to answer that question with confidence. The answer is yes." — Todd Cummings, Vice President of Product Strategy, Synergis SoftwareUnlimited Users. No Per-Seat Costs.Every Adept Cloud plan — Essentials, Professional, and Enterprise — includes unlimited users. No per-seat costs, and no limits on who can access the system, from engineers at their desks to teams in the field or on the plant floor.Synergis will host an Adept Cloud webinar for customers on June 4, and an Adept Cloud introduction webinar open to all interested organizations on June 17.Adept AI: Intelligence Where Your Engineering Data LivesAdept AI is built for the Adept Cloud platform — artificial intelligence capabilities that help engineering organizations surface information faster, accelerate document-intensive work, and extract more value from the engineering data already in their system."Engineering information is one of the most valuable and underutilized assets in any industrial organization — critical context buried within tens or hundreds of thousands of documents, largely inaccessible. Adept AI changes that by putting intelligence to work at the platform layer — inside the system where the data already lives, with the governance and security that asset-intensive industries require."— Scott Lamond, Vice President of Marketing, Synergis SoftwareGetting Started with Adept CloudAdept Cloud is available today. New customers work with their dedicated customer success manager through an onboarding plan that aligns with their Adept Cloud Plan and streamlines time to value. Existing Adept customers can transition to Adept Cloud through a personalized plan designed to minimize disruption and maximize continuity.Recognition and Customer TrustSynergis Adept was named to G2's 2026 Best Software Awards as the top-ranked engineering document management platform. The platform holds G2 distinctions for Best Support, Best Relationship, and Highest User Adoption. 95% of verified G2 reviews are rated four or five stars.About Synergis SoftwareSynergis Software is the creator of Adept, a leading engineering document management platform trusted by global organizations including Dow, Con Edison, Merck, and General Mills — and named to G2's 2026 Best Software Awards as the top-ranked engineering document management platform. For more than 35 years, Synergis has helped asset-intensive industries — including manufacturing, chemicals, utilities, oil and gas, life sciences, and mining — centralize, govern, and leverage engineering information to accelerate projects, strengthen compliance, and reduce operational risk. Adept is available both as a fully managed SaaS platform and as an on-premise solution.For more information, visit SynergisSoftware.com.MEDIA CONTACT
Scott Lamond
Vice President of Marketing, Synergis Software
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Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial CancerMay 18, 2026 6:45 AM
Business Wire Sac-TMT is the first TROP2 ADC to improve OS and PFS compared to chemotherapy in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy in a global Phase 3 study Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the pivotal Phase 3 TroFuse-005 trial evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in certain patients with advanced or recurrent endometrial cancer. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients and the first and only ADC to do so for patients with endometrial cancer in this setting. At a pre-specified interim analysis, sac-TMT demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared to treatment of physician’s choice (TPC, consisting of doxorubicin or paclitaxel) for patients with endometrial cancer who have previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy either together or separately. The study also reached its key secondary endpoint of objective response rate. These data will be presented at an upcoming medical meeting and discussed with regulatory authorities worldwide. The safety profile was consistent with what has been observed in previously reported studies of sac-TMT; no new safety signals were observed. “These results show sac-TMT may be able to address a critical unmet need for certain patients with advanced endometrial cancer, one of the only cancers increasing in both incidence and mortality worldwide,” said Dr. Domenica Lorusso, the study’s global lead investigator, lead investigator for ENGOT and professor of Obstetrics and Gynecology at Humanitas University and Humanitas San Pio X, Milan. “Despite recent advances, patients whose disease progresses following treatment with platinum and immunotherapy are urgently in need of new options, and these findings show for the first time that a TROP2 ADC may be an effective option in this setting.” “The scale and ambition of our expansive TroFuse program reflects our deep commitment to advancing one of the industry’s leading ADC pipelines to make a difference for more people facing cancer and builds on our legacy of leadership in gynecologic cancer research,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These findings reinforce our belief that sac-TMT, with its proprietary bifunctional linker designed with the intent to maximize payload delivery to tumors while minimizing impact on healthy cells in the body, has the potential to become a cornerstone in the treatment of certain patients with advanced endometrial cancer. We thank the patients and investigators for participating in our studies as well as our collaborators at Kelun-Biotech for helping us advance this important treatment.” TroFuse-005 also marks the first positive Phase 3 results from Merck’s TroFuse clinical development program for sac-TMT. The program currently consists of 17 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date, including 10 Phase 3 trials in women’s cancers. The program is evaluating sac-TMT across a diverse range of tumor types, including endometrial, bladder, breast, cervical, gastric, non-small cell lung and ovarian cancers, and it spans early-to-late-stage disease as both monotherapy and in combination with immunotherapies. This includes the ongoing TroFuse-033 trial in first line mismatch repair proficient endometrial cancer. About TroFuse-005 TroFuse-005 is a randomized, active-controlled, open-label, multicenter, global Phase 3 trial (ClinicalTrials.gov, NCT06132958) evaluating sac-TMT versus TPC in patients with endometrial carcinoma and carcinosarcoma who have received prior platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy either together or separately. The trial enrolled 776 patients who were randomized to receive either sac-TMT or TPC, consisting of doxorubicin or paclitaxel. Sac-TMT (4 mg/kg) was administered on Day 1 of each two-week treatment cycle. Doxorubicin (60 mg/m²) was administered on Day 1 of each three-week treatment cycle and paclitaxel (80 mg/m²) was administered on Days 1, 8 and 15 of each four-week treatment cycle. The study has dual primary endpoints: PFS by blinded independent central review (BICR), defined as the time from randomization to the first documented disease progression or death from any cause, and OS, defined as the time from randomization to death from any cause. A key secondary endpoint is objective response rate, and other secondary endpoints include duration of response, incidence of adverse events, treatment discontinuation due to adverse events and change from baseline in global health status/quality-of-life scores. About sacituzumab tirumotecan (sac-TMT) Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a bifunctional linker designed with the potential to maximize payload delivery to tumor cells and minimize payload loss while circulating in the body. Sac-TMT is the only TROP2 ADC designed with a focus on both ends of the linker. TROP2 is overexpressed on tumor cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 17 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. The TroFuse development program spans early-to-late-stage disease in more than nine disease areas and includes more than 15,000 patients worldwide. Numerous Phase 3 trials are exploring sac-TMT as monotherapy and in combination with immunotherapies, aiming to improve survival and quality of life for patients with advanced and earlier-stage cancers. About endometrial cancer Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall. Following primary treatment, patients face a risk of their cancer returning, often as distant metastasis, which is associated with poorer outcomes. About Merck’s research in women’s cancers Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecologic cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to provide options to patients facing these devastating diseases. With more than 20 clinical trials in nearly 20,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Through our portfolio and pipeline, Merck is working to address the impact of women’s cancers on patients, their families and communities globally. About the Merck and Kelun-Biotech strategic collaboration Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan). Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).  View source version on businesswire.com: https://www.businesswire.com/news/home/20260518302676/en/ Media Contacts: Julie Cunningham
julie.cunningham@merck.com John Infanti
john.infanti @Edwin48 Steven Graziano
(732) 594-1583 Original: Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial Cancer

Next-Generation GLP-1 Innovation Could Unlock Massive Metabolic Healthcare Market OpportunitiesMay 13, 2026 9:00 AM
InvestorsHub NewsWireNext-Generation GLP-1 Innovation Could Unlock Massive Metabolic Healthcare Market OpportunitiesBioMedWire Editorial Coverage: Obesity and type 2 diabetes mellitus ("T2DM") rank among the most urgent and costly healthcare problems facing the world today, contributing to surging rates of cardiovascular disease, fatty liver disease, kidney complications and ballooning healthcare expenses. What once represented a specialized class of diabetes treatments has grown into one of the most consequential therapeutic categories in modern medicine, with GLP-1 receptor agonists now fundamentally restructuring how obesity, metabolic disease and potentially even neurodegeneration are treated. Operating in this environment is SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) (Profile), which through its subsidiary GlucaPharm Inc. is developing a distinct next-generation GLP-1 platform built around GEP-44, a novel triple agonist peptide engineered to improve efficacy, tolerability, and delivery flexibility within one of the most commercially dynamic pharmaceutical markets in history. SureNano is one of the emerging microcap companies active in the GLP-1 space, operating alongside established leaders including Merck & Co. Inc. (NYSE: MRK), AbbVie Inc. (NYSE: ABBV), Viking Therapeutics Inc. (NASDAQ: VKTX) and Altimmune Inc. (NASDAQ: ALT).SureNano Science is developing GEP-44 as a patented next-generation metabolic therapy designed to address the limitations of first-generation GLP-1 drugs.The commercial potential tied to GLP-1 therapies is expanding quickly, with the global GLP-1 market forecast to potentially reach $190 billion by 2035.SureNano Science is also eyeing differentiated drug-delivery technologies designed to improve patient accessibility and long-term adherence.Preclinical data from SureNano Science suggest that GEP-44 may offer substantive differentiation relative to earlier-generation GLP therapies.Beyond its primary GLP-1 metabolic platform, SureNano Science is also evaluating early-stage opportunities that could expand the long-term scope of its therapeutic and delivery technology portfolio.Click here to view the custom infographic of the SureNano Science editorial. Rewriting the Rules of Metabolic MedicineThe global obesity crisis shows no sign of plateauing. According to the World Health Organization ("WHO"), a reported one billion people globally are currently living with obesity, while type 2 diabetes rates continue to climb across both high-income and developing economies. The WHO further notes that obesity increases the risk of cardiovascular disease, stroke and T2DM, while further research has linked obesity to chronic kidney disease and rising healthcare expenditures, placing substantial and growing pressure on health systems around the world.GLP-1 receptor agonists have rapidly risen to become one of the defining breakthroughs in metabolic medicine. Originally introduced to manage blood glucose levels in diabetes patients, these drugs are now recognized for their capacity to drive meaningful weight reduction and deliver broad improvements in metabolic health. Market leaders Novo Nordisk A/S and Eli Lilly and Company have come to dominate the space through their blockbuster injectable franchises, including Ozempic(R), Wegovy(R), Mounjaro(R) and Zepbound(R).Commercial momentum in this space is increasing. JPMorgan Chase & Co. forecasts that the general obesity drug market could reach $200 billion by 2030 as global adoption expands and indications stretch beyond diabetes and weight management. Additional industry projections suggest GLP-1 therapies are on track to become one of the most commercially successful drug categories ever, with annual sales projections of $150 billion or more by the end of the decade.The industry is already pivoting toward the next generation of incretin therapies, with a focus on improved efficacy, tolerability and patient convenience. Needle-free, including oral, formulas, expanded indications and combination metabolic approaches have emerged as major priorities across the sector. SureNano Science is positioning itself in this scenario as a nimble participant pursuing differentiated innovation through GEP-44, a patented triple agonist peptide licensed from Syracuse University and designed to advance through the U.S. Food and Drug Administration ("FDA") regulatory route.A Next-Gen Candidate Built for Better OutcomesSureNano Science is developing GEP-44 as a patented next-generation metabolic therapy designed to address the limitations of first-generation GLP-1 drugs, positioning this up-and-coming microcap as a small but strategically focused company moving through the FDA process. Unlike traditional GLP-1 agonists, which act on a single receptor pathway, GEP-44 functions as a triple agonist targeting GLP-1 alongside peptide YY receptors Y1 and Y2. This combined mechanism is designed to simultaneously regulate glucose metabolism, reduce appetite and improve tolerability within a single therapeutic molecule.The compound originated at Syracuse University and has generated promising results in preclinical settings. According to research, GEP-44 produced meaningful reductions in food intake and decreased body weight while also enhancing glycemic control in preclinical models. In addition, the compound did not trigger the nausea, malaise and gastrointestinal adverse effects commonly seen with many first-generation GLP-1 therapies, a distinction that could become increasingly significant as patient populations and adherence demands grow.The broader pharmaceutical industry is investing aggressively in incretin therapies that can address tolerability and long-term adherence challenges. PwC reports that the next segment of the obesity drug market will most likely be characterized by expanded indications, more patient-friendly delivery formats and therapies with stronger adherence profiles. This lends itself to a supportive environment for companies pursuing second-generation GLP innovation.Despite being smaller than more-established pharmaceutical players, SureNano Science operates with a lean development model and cost-efficient structure built for flexibility and development speed. The company is involved in substantial research in Australia, where government incentive programs may provide research tax credits of up to 43.5% on qualifying expenditures. Should GEP-44 continue producing favorable results through clinical development, the company could emerge as an attractive acquisition, licensing or partnership candidate within the fast-expanding GLP ecosystem.Market Scale and the Commercial Case for GLP-1 InnovationThe commercial potential tied to GLP-1 therapies is expanding quickly. According to Morgan Stanley, the global GLP-1 market could reach $190 billion by 2035 as patient adoption broadens and therapeutic applications extend into new disease areas. Industry forecasts from BCC Research also forecast significant long-term growth, with the GLP-1 analogue market estimated to reach $268.4 billion by 2030.Patient uptake estimates that between 25 and 30 million Americans could be using GLP-1 therapies by 2030, up from approximately 10 million in 2026. Increasing insurance coverage along with obesity prevalence and growing physician familiarity are all driving the rapid mainstreaming of these treatments.At the same time, the competitive setting is shifting toward the next wave of products. IQVIA calls 2026 the "year of the orals," with oral GLP-1 formulations projected to meaningfully enhance accessibility, compliance and long-term maintenance therapy adoption. The anticipated off-patent expansion of semaglutide across major global markets is also expected to intensify competition while broadening overall patient access.As GEP-44 advances through IND-enabling studies and moves toward eventual phase 1 trials, SureNano Science stands as one of a small number of microcap public companies offering direct exposure to the expanding GLP-1 market. This positioning may represent a meaningful valuation gap relative to large-cap pharmaceutical incumbents and late-stage obesity therapy developers, particularly if the company achieves key clinical and regulatory milestones.Delivery Innovation as a Second Engine of ValueAlongside its core therapeutic development efforts, SureNano Science is also eyeing differentiated drug-delivery technologies designed to improve patient accessibility and long-term adherence. The company's platform strategy includes evaluating oral, sublingual and intranasal delivery approaches that could eventually reduce reliance on injectable administration.Convenience and adherence have emerged as increasingly important competitive dimensions within the GLP-1 market. The dominant therapies today are injection-based, creating barriers for some patients due to administration complexity, refrigeration requirements and long-term compliance challenges. Noninvasive and oral alternatives are widely regarded as representing one of the most significant near-term commercial opportunities in obesity and diabetes treatment.Industry analysts increasingly view delivery innovation as potentially as consequential as efficacy improvements. IQVIA notes that oral obesity therapies could substantially boost long-term maintenance adoption while simplifying supply chains by removing cold-chain requirements, factors that could meaningfully expand patient access in international markets.By combining therapeutic development with delivery innovation, SureNano Science is working to build a vertically integrated metabolic disease platform rather than advancing a single injectable drug candidate. This broader strategy may generate additional long-term optionality and commercial flexibility as the obesity treatment market continues to evolve.Preclinical Data Point to a Meaningful Competitive EdgePreclinical data from SureNano Science suggest that GEP-44 may offer substantive differentiation relative to earlier-generation GLP therapies. According to the company, the compound demonstrated approximately 15% weight loss in preclinical testing, compared with roughly 9% observed with liraglutide, while food intake reductions reached approximately 39% versus around 20% for the comparator.In addition to weight reduction, GEP-44 produced improvements in glycemic control while reportedly avoiding nausea and vomiting during testing. Gastrointestinal side effects remain among the most frequently cited challenges associated with currently marketed GLP-1 therapies and represent a significant driver of discontinuation. Improved tolerability could therefore become a meaningful competitive advantage if these preclinical findings are validated in human studies.The pharmaceutical industry continues to pour resources into next-generation obesity therapies capable of delivering better outcomes and patient experiences. The Pharma Letter reports that obesity drug pipelines are increasingly oriented toward differentiation through combination receptor pathways, improved tolerability profiles, and expanded delivery options as the competitive field intensifies.While GEP-44 remains in preclinical development, these early findings place SureNano Science within a strategically important segment of the obesity treatment landscape. If subsequent studies continue to support these results, the company could establish itself as a distinctive participant in one of the largest and most rapidly expanding therapeutic categories in contemporary healthcare.Exploring Broader Platform Opportunities for Long-Term GrowthBeyond its primary GLP-1 metabolic platform, SureNano Science is also evaluating early-stage opportunities that could expand the long-term scope of its therapeutic and delivery technology portfolio. These discussions include nonbinding opportunities involving ibogaine-related intellectual property concentrated on formulation and delivery technologies.While still exploratory and not considered a core asset at this stage, the initiative reflects a broader strategic aim of building diversified platform capabilities across multiple high-growth therapeutic areas. Scientific and investor interest in ibogaine and related psychedelic-derived therapeutics has grown considerably in recent years, as researchers examine their potential applications in addiction treatment, mental health conditions, and neurological disorders.CNN recently reported on the growing scientific and regulatory attention being directed at ibogaine research, particularly in areas related to opioid addiction and treatment-resistant mental health conditions. The U.S. Food and Drug Administration has also signaled increasing openness to accelerating development pathways for treatments targeting serious mental illnesses and areas of significant unmet medical need.SureNano's interest in formulation and delivery technologies within these emerging areas fits naturally with the company's broader emphasis on drug-delivery innovation and platform versatility. Rather than treating ibogaine-related opportunities as a standalone commercial priority, the company appears to be assessing how specialized delivery technologies and intellectual property could complement its existing capabilities in metabolic therapeutics and nontraditional administration. This kind of optionality may provide incremental long-term strategic value if the regulatory landscape surrounding psychedelic-based therapies continues to evolve.These initiatives remain early stage and are subject to meaningful scientific, clinical and regulatory uncertainty. However, by selectively evaluating expansion opportunities alongside its primary GLP-1 development program, SureNano Science is aligning itself with a broader trend toward diversified therapeutic platforms capable of competing across multiple large and evolving healthcare markets. As pharmaceutical innovation increasingly converges around metabolic health, neuroscience, and advanced delivery technologies, strategic flexibility may prove to be a growing differentiator for emerging biotechnology companies.Advances Continue Across the GLP-1 LandscapeMomentum across the GLP-1 and metabolic disease sector continues to accelerate as leading biotechnology and pharmaceutical companies expand development programs targeting obesity, diabetes, liver disease and broader cardiometabolic conditions. Recent news from the GLP-1 space highlights continued investment in next-generation therapies, late-stage clinical development, strategic partnerships and regulatory progress as the rapidly evolving space remains one of the most closely watched areas in healthcare and biotechnology.Merck & Co. Inc. (NYSE: MRK) expanded into the GLP-1 and obesity-treatment market through an exclusive global licensing agreement with Hansoh Pharma for an investigational oral GLP-1 receptor agonist. Merck stated that the candidate is being developed for cardiometabolic diseases and described the agreement as part of the company's strategy to strengthen its presence in metabolic disorders. The company noted that it will receive exclusive rights outside China to develop, manufacture and commercialize the therapy, reflecting a growing industry focus on oral GLP-1 treatments for obesity and related conditions.AbbVie Inc. (NYSE: ABBV) announced positive topline results from a phase 1 multiple ascending dose study evaluating ABBV-295, its long-acting amylin analog being developed for obesity and metabolic disease treatment. AbbVie reported that ABBV-295 demonstrated "clinically meaningful" body weight reduction ranging from approximately 7.75% to 9.79% over the treatment period, while also showing a "favorable tolerability profile" with no serious adverse events reported. The company emphasized that the data support continued advancement of its metabolic disease pipeline amid increasing interest in next-generation obesity therapies that may complement or compete with GLP-1 drugs.Viking Therapeutics Inc. (NASDAQ: VKTX) reported completion of enrollment in its phase 3 VANQUISH-2 trial evaluating VK2735, its dual GLP-1/GIP receptor agonist candidate for obesity treatment. Viking stated that the study is assessing subcutaneous VK2735 in adults with obesity and type 2 diabetes, while concurrent phase 3 development is also ongoing in broader obesity populations. The company noted that VK2735 is being developed in both oral and injectable formulations for metabolic disorders, underscoring its position in the rapidly expanding GLP-1 obesity-treatment landscape.Altimmune Inc. (NASDAQ: ALT) announced that pemvidutide received FDA Breakthrough Therapy designation for the treatment of MASH, further advancing development of the company's GLP-1/glucagon dual receptor agonist platform. Altimmune stated that pemvidutide has demonstrated improvements in liver fat reduction, weight loss and fibrosis-related measures, while the company plans to initiate a Phase 3 trial evaluating multiple doses over a 52-week treatment period. The announcement reinforces Altimmune's ongoing efforts to position pemvidutide within the broader GLP-1 and metabolic disease sector spanning obesity, liver disease and related cardiometabolic conditions.Collectively, these developments underscore the growing importance of GLP-1-related therapies as companies compete to address some of the world's largest and fastest-growing chronic health challenges. With ongoing advances in oral formulations, combination therapies and expanded metabolic disease applications, the sector continues to attract significant scientific, clinical and investor attention while reshaping the future landscape of obesity and cardiometabolic treatment.For further information about SureNano Science Ltd., visit the SureNano Science profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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Merck Highlights New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO 2026May 12, 2026 6:45 AM
Business Wire Five-year follow-up data from KEYNOTE-942 underscore the continued potential of intismeran autogene (mRNA-4157 or V940) in combination with KEYTRUDA® (pembrolizumab) for patients with resected high-risk melanoma Results from the final analysis of KEYNOTE-522, evaluating KEYTRUDA in combination with chemotherapy, demonstrate continued survival benefit for patients with high-risk early-stage triple-negative breast cancer (TNBC) New data for sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate, add to ongoing research of novel treatment approaches for patients with non-small cell lung cancer Data from ASCENT-04/KEYNOTE-D19, evaluating KEYTRUDA plus Trodelvy® (sacituzumab govitecan-hziy) for patients with metastatic TNBC, will be featured in the official ASCO 2026 Press Program Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new research from more than 100 abstracts across over 25 types of cancer from the company’s comprehensive oncology portfolio and pipeline will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2). The data reinforce the long-term impact of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, and Merck’s rapidly advancing pipeline across multiple tumor types and stages of disease, highlighting the company’s leadership in oncology and commitment to advancing innovative oncology research. “During ASCO, we will present data that showcase the strong momentum in our oncology pipeline, including long-term data for intismeran autogene, our investigational individualized neoantigen therapy (INT),” said Dr. Marjorie Green, senior vice president and head of oncology global clinical development, Merck Research Laboratories. “We look forward to sharing new research for our oncology medicines and novel treatment approaches, such as our INT and antibody-drug conjugates, which may help address significant unmet medical needs for patients living with cancer.” Key data from Merck’s portfolio and pipeline to be presented: Five-year follow-up data from the Phase 2b KEYNOTE-942 trial evaluating intismeran autogene in combination with KEYTRUDA for patients with high-risk melanoma following complete resection (Abstract #9500, Oral abstract session: Melanoma/skin cancers).1 Final analysis results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as pre-operative treatment and then continuing as a single agent after surgery for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) (Abstract #507, Oral abstract session: Breast cancer – local/regional/adjuvant). Data from the Phase 3 OptiTROP-Lung05 trial conducted in China, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in advanced non-small cell lung cancer (Abstract #8506, Oral abstract session: Lung cancer – non-small cell metastatic).2 Progression-free survival data from the Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating KEYTRUDA plus Trodelvy (sacituzumab govitecan-hziy) in previously untreated PD-L1-positive metastatic TNBC ??(Abstract #LBA1000, Oral abstract session: Breast cancer – metastatic).?3 Merck investor event Merck will hold an Oncology Investor Event to coincide with the 2026 ASCO Annual Meeting on Monday, June 1, 2026, 6 p.m. CT, during which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation via this weblink. All participants may join the call by dialing (800) 369-2154 (U.S. and Canada Toll-Free) or (517) 308-9422 and using the access code 8711041. Details on abstracts listed above and additional key abstracts for Merck Breast cancer Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Final analysis results from the Phase 3 KEYNOTE-522 study. P. Schmid. Abstract #507, Oral abstract session:
Breast cancer – local/regional/adjuvant Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro. K. Kalinsky.?3 Abstract #LBA1000, Oral abstract session:
Breast cancer – metastatic Gastrointestinal cancers   KEYNOTE-811: 6-year median follow-up of pembrolizumab plus trastuzumab and chemotherapy for previously untreated advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. A. Kawazoe. Abstract #4040, Poster session:
Gastrointestinal cancer – gastroesophageal, pancreatic and hepatobiliary Genitourinary cancers Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the Phase 3 EV-302 study. T. Powles.4 Abstract #4507, Oral abstract session:
Genitourinary cancer – kidney and bladder Extended follow up (6-years) of the Phase 2 LITESPARK-004 study of belzutifan in participants with von Hippel-Lindau disease-associated neoplasms. R. Srinivasan. Abstract #4550, Poster session:
Genitourinary cancer – kidney and bladder Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study. P. O’Donnell.4 Abstract #4510, Clinical science symposium:
New approaches to curing bladder and kidney cancer Health-related quality of life (HRQoL) with pembrolizumab or observation for high-risk muscle-invasive urothelial carcinoma after surgery: Results from the AMBASSADOR randomized trial (Alliance A031501). R. Chen.?5 Abstract #4513, Oral abstract session:
Genitourinary cancer – kidney and bladder Belzutifan in docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): Phase 1b/2 KEYNOTE-365 cohort J. J. Arranz.? Abstract #5058, Poster session:
Genitourinary cancer – prostate, testicular and penile Gynecologic cancers   Updated overall survival analysis and examination of subsequent therapy in endometrial cancer (EC) patients (pts) treated with pembrolizumab plus carboplatin/paclitaxel (CP) as compared to CP plus placebo (PBO) in the NRG-GY018 trial. R. Eskander.6 Abstract #5502, Oral abstract session:
Gynecologic cancer Exposure-response (E-R) analyses of efficacy and safety with raludotatug deruxtecan (R-DXd), a CDH6-directed antibody-drug conjugate (ADC), to inform dose selection for Phase (Ph) 3 development in platinum-resistant ovarian cancer (PROC). F. Hurtado.7 Abstract #5570, Poster session:
Gynecologic cancer Lung cancer Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus pembrolizumab(P) as first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC): Results from the randomized Phase 3 OptiTROP-Lung05 study. C. Zhou.?2 Abstract #8506, Oral abstract session:
Lung cancer – non-small cell metastatic Melanoma Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study. M. Carlino.?1 Abstract #9500, Oral abstract session:
Melanoma/skin cancers Biomarkers Development and evaluation of a novel digital pathology image analysis pipeline for prediction of clinical outcomes with the TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in triple-negative breast cancer (TNBC). S. Tolaney.? Abstract #1026, Poster session:
Breast cancer – metastatic 1 In collaboration with Moderna
2 Led by Kelun-Biotech, conducted in China
3 In collaboration with Gilead. Trodelvy is a registered trademark of Gilead Sciences, Inc., or its related companies.
4 In collaboration with Astellas/Pfizer
5 Sponsored by U.S. National Cancer Institute (NCI)/led by Alliance for Clinical Trials in Oncology
6 Sponsored by U.S. National Cancer Institute (NCI)/led by NRG Oncology
7 In collaboration with Daiichi Sankyo About intismeran autogene (mRNA-4157 or V940) Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumor. About sacituzumab tirumotecan (sac-TMT) Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a bifunctional linker designed with the potential to maximize payload delivery to tumor cells and minimize payload loss while circulating in the body. Sac-TMT is the only TROP2 ADC designed with a focus on both ends of the linker. TROP2 is overexpressed on tumor cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 17 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. The TroFuse development program spans early-to-late-stage disease in more than nine disease areas and includes more than 15,000 patients worldwide. Numerous Phase 3 trials are exploring sac-TMT as monotherapy and in combination with immunotherapies, aiming to improve survival and quality of life for patients with advanced and earlier-stage cancers. About raludotatug deruxtecan (R-DXd) Raludotatug deruxtecan is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA® (pembrolizumab) Indications in the U.S. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Merck Scientists Publish Landmark Paper on Novel Method for Large-Scale Biocatalytic Synthesis of Investigational Oral PCSK9 Inhibitor, Enlicitide DecanoateMay 7, 2026 2:05 PM
Business Wire Publication in Science magazine outlines blueprint for the scalable synthesis of complex orally available macrocyclic peptides Enlicitide, a novel macrocyclic peptide, has the potential to be the first approved oral PCSK9 inhibitor Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today the publication of work describing the large-scale synthesis of enlicitide decanoate, the company’s investigational oral PCSK9 inhibitor, using a tailored suite of enzymes in the latest issue of the peer reviewed journal Science. “Macrocyclic peptides have the potential to unlock new opportunities to develop oral treatment options for challenging therapeutic targets and broaden patient access,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “The scalable production process for enlicitide described in this publication showcases Merck’s scientific capabilities and underscores our sustained commitment to helping address the global cardiovascular epidemic.” In this publication, Merck scientists detail the biocatalytic assembly of enlicitide using a suite of enzymes that catalyze selective peptide fragment formation, coupling, and macrocyclization. Together with efficient purifications using crystallization, this strategy enabled the manufacture of a product that would not be possible with traditional synthetic methods. The method described offers a sustainable blueprint for the scalable development of complex macrocyclic peptide therapeutics, environmental advantages and manufacturing efficiencies that support efforts to expand patient access. About biocatalysis Biocatalysis describes the process of using enzymes to conduct chemical synthesis. Biocatalysis offers environmental sustainability advantages over chemical catalyst methods. For more than 25 years Merck has invested in the development of biocatalysis including the generation of novel enzymes for the synthesis and novel manufacturing of pharmaceutical products at scale. About macrocyclic peptides Over a decade ago, an interdisciplinary team of Merck scientists were challenged to create a type of medicine that may provide the potency and selectivity of a biologic therapy but in the form of a pill. Macrocyclic peptides are intricate ring-shaped molecules with the ability to target and disrupt protein-protein interactions while retaining oral bioavailability. For more information regarding our approach to macrocyclic peptides, visit merck.com About enlicitide and PCSK9 Enlicitide has the potential to be the first approved oral PCSK9 inhibitor. It is designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody, injectable PCSK9 inhibitors but in a daily pill form. Enlicitide is a novel macrocyclic peptide candidate that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors. PCSK9 plays a key role in cholesterol homeostasis by regulating levels of the LDL receptor, which is responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 is designed to prevent the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood. About the CV epidemic and atherosclerotic cardiovascular disease The silent CV epidemic is the leading cause of deaths globally, contributing to the majority of heart attacks and strokes, and deaths related to CV continue to rise. ASCVD accounts for 85% of CV deaths. It is caused by the buildup of plaque within the arteries, leading to narrowed or blocked blood vessels that can result in serious CV events such as heart attacks and strokes as well as coronary artery disease, peripheral artery disease and cerebrovascular disease. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260507354410/en/ Media Contacts:
Julie Cunningham
(617) 519-6264 Kimberly Petrillo
(267) 742-2813 Investor Contacts:
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(732) 594-1579 Ayn Wisler
(917) 691-6218 Original: Merck Scientists Publish Landmark Paper on Novel Method for Large-Scale Biocatalytic Synthesis of Investigational Oral PCSK9 Inhibitor, Enlicitide Decanoate

Merck tops Q1 estimates on strong oncology demand; shares riseApril 30, 2026 8:41 AM
IH Market News
Shares of Merck & Co., Inc. (NYSE:MRK) climbed more than 4% in premarket trading on Thursday after the company reported first-quarter results that exceeded analyst expectations, supported by solid performance in oncology and animal health.The drugmaker posted an adjusted loss per share of $1.28, beating the consensus estimate of a $1.48 loss. Revenue came in at $16.29 billion, above the $15.89 billion forecast and marking a 5% increase year-over-year, or 3% excluding foreign exchange effects, compared with $15.53 billion in the same quarter last year.Both adjusted and GAAP results included a $3.62 per share charge related to the acquisition of Cidara Therapeutics.Sales of KEYTRUDA and KEYTRUDA QLEX reached $8.03 billion, rising 12% from a year earlier, or 8% on a constant currency basis. Growth was driven by stronger global demand in metastatic treatments and continued expansion in earlier-stage indications.WINREVAIR sales jumped 88% to $525 million, reflecting ongoing uptake in the U.S. and initial international launches. The Animal Health division also delivered strong results, with sales increasing 13% to $1.79 billion.“We are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas,” said Robert M. Davis, chairman and chief executive officer.For full-year 2026, Merck raised and tightened its revenue outlook to a range of $65.8 billion to $67.0 billion, compared with the previous $65.5 billion to $67.0 billion.The company also increased its adjusted EPS guidance to between $5.04 and $5.16, up from the prior range of $5.00 to $5.15. This outlook includes the $3.62 per share impact from the Cidara acquisition but excludes the planned acquisition of Terns Pharmaceuticals, expected to close in May, which would result in an additional one-time charge of about $2.35 per share.The midpoint of $5.10 for adjusted EPS reflects the company’s updated expectations for the year.Merck stock price

Original: Merck tops Q1 estimates on strong oncology demand; shares rise

Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical MilestonesApril 30, 2026 6:30 AM
Business Wire
Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches



Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX)


KEYTRUDA/KEYTRUDA QLEX1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million



WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX)



Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX)






GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Charge of $3.62 per Share for the Acquisition of Cidara



Presented New Data From Cardio-Pulmonary Pipeline at ACC.26, Including Positive Results From Phase 3 CORALreef AddOn Trial



Received U.S. FDA Approval for IDVYNSO, a Once-Daily, Oral Treatment for Certain Adults With Virologically Suppressed HIV-1



Achieved Multiple Significant Regulatory and Clinical Milestones Across Oncology Pipeline



Announced Agreement To Acquire Terns Pharmaceuticals, Inc. and Expand Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia; Transaction Expected To Close in May



Full-Year 2026 Financial Outlook


Narrows and Raises the Midpoint of Worldwide Sales Range; Now Expects Sales To Be Between $65.8 Billion and $67.0 Billion



Narrows and Raises Expected Non-GAAP EPS Range To Be Between $5.04 and $5.16



Outlook Does Not Reflect Any Impact From Proposed Acquisition of Terns Pharmaceuticals, Inc., Which Is Expected To Close in May and Result in a One-Time Charge of Approximately $5.8 Billion or Approximately $2.35 per Share






Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2026.


“We are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas,” said Robert M. Davis, chairman and chief executive officer. “During the first quarter, we continued to strengthen our pipeline with science-led business development, including our planned acquisition of Terns. We also achieved several important milestones, such as the FDA approval of IDVYNSO – which marks a new chapter in our longstanding commitment to people living with HIV. I am pleased with our progress and excited for what’s ahead, as we enter a particularly robust period of Phase 3 data readouts and deliver on the promise of our pipeline for patients.”


Financial Summary




$ in millions, except EPS amounts






First Quarter








2026 






2025 






Change 






Change 

Ex- 

Exchange 








Sales






$16,286 






$15,529 






5% 






3% 








GAAP net (loss) income2






(4,240) 






5,079 






N/M 






N/M 








Non-GAAP net (loss) income that excludes certain items2,3*






(3,156) 






5,611 






N/M 






N/M 








GAAP EPS






(1.72) 






2.01 






N/M 






N/M 








Non-GAAP EPS that excludes certain items3*






(1.28) 






2.22 






N/M 






N/M 








*Refer to table on page 7.








N/M - Not meaningful.







For the first quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $1.72 and non-GAAP loss per share was $1.28. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Cidara Therapeutics, Inc. (Cidara) of $3.62 per share.


Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities.


First-Quarter Sales Performance

The following table reflects sales of the Company’s top products and significant performance drivers.




 






First Quarter








$ in millions






2026 






2025 






Change 






Change 

Ex- 

Exchange 






Commentary








Total Sales






$16,286 






$15,529 






5% 






3% 






 








Pharmaceutical






14,349 






13,638 






5% 






2% 






Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by declines in vaccines, diabetes and infectious diseases.








KEYTRUDA/ KEYTRUDA QLEX






8,034 






7,205 






12% 






8% 






Growth primarily driven by higher global demand in metastatic indications including urothelial cancer, as well as strong global uptake in earlier-stage indications, including triple-negative breast cancer, cervical cancer and renal cell carcinoma (RCC). Sales growth benefited from the timing of wholesaler purchases in the U.S. Sales of KEYTRUDA QLEX were $128 million.








GARDASIL/

GARDASIL 9






1,069 






1,327 






-19% 






-22% 






Decline primarily due to lower demand in China as well as lower sales in Japan following the national catch-up immunization program. Decline also reflects lower sales in the U.S. primarily due to unfavorable public-sector purchasing patterns, partially offset by higher net pricing.








JANUVIA/JANUMET






574 






796 






-28% 






-29% 






Decline primarily due to lower demand and net pricing in the U.S., as well as lower demand in China and most other international markets due to generic competition.








PROQUAD, M-M-R II and VARIVAX






538 






539 






0% 






-2% 






Sales were flat, primarily driven by unfavorable private sector purchasing patterns for M-M-R II and lower demand for M-M-R II and VARIVAX in the U.S., offset by higher PROQUAD sales in the U.S. due to borrowing of doses in 2025 from a U.S. government stockpile, which lowered sales in that period.








WINREVAIR






525 






280 






88% 






87% 






Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.








BRIDION






472 






441 






7% 






7% 






Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.








Lynparza*






341 






312 






9% 






6% 






Growth primarily due to higher demand in the U.S. and many international markets.








PREVYMIS






272 






208 






31% 






26% 






Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.








Lenvima*






256 






258 






-1% 






-2% 






Relatively flat compared with prior year.








ROTATEQ






206 






228 






-10% 






-11% 






Decrease primarily driven by lower demand in China.








VAXNEUVANCE






202 






230 






-12% 






-16% 






Decrease primarily driven by lower demand in the U.S. and most international markets due to competitive pressure.








WELIREG






199 






137 






45% 






43% 






Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan and certain European markets.








CAPVAXIVE






142 






107 






33% 






31% 






Increase primarily driven by launch uptake in certain European markets and continued uptake in the U.S. U.S. sales growth was partially offset by a reduction in wholesaler inventory.








OHTUVAYRE






131 






- 






- 






- 






Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc (Verona Pharma).








LAGEVRIO






28 






102 






-73% 






-73% 






Decline largely due to lower demand in Japan and the U.S.








Animal Health






1,791 






1,588 






13% 






6% 






Growth attributable to performance in both Livestock and Companion Animal product portfolios.








Livestock






1,064 






924 






15% 






8%






Growth primarily driven by higher demand for ruminant and poultry products as well as price.








Companion Animal






727 






664 






9% 






4% 






Growth from new product launches and price was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $379 million and $327 million in current and prior-year quarters, respectively, which represents an increase of 16%, or 9% excluding impact of foreign exchange.








Other Revenues**






146 






303 






-52% 






4% 






Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements, partially offset by higher milestones received for out-licensing arrangements and higher royalty income.








*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.








**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.







In addition, Koselugo alliance revenue was $161 million for the first quarter of 2026 compared with $44 million for the first quarter of 2025. The increase was due to a $150 million payment received in the first quarter of 2026 in connection with an amendment to the collaboration agreement with AstraZeneca in 2025, which (subject to an annual election by AstraZeneca) discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure.


First-Quarter Expense and Related Information

The table below presents selected expense information.




$ in millions






GAAP 






Acquisition- 

and 

Divestiture- 

Related Costs4 






Restructuring 

Costs 






(Income) 

Loss From 

Investments 

in Equity 

Securities 






Non- 

GAAP3 








First Quarter 2026













Cost of sales






$4,195 






$1,014 






$237 






$ - 






$2,944 








Selling, general and administrative






2,700 






32 






- 






- 






2,668 








Research and development






12,592 






- 






34 






- 






12,558 








Restructuring costs






195 






- 






195 






- 






- 








Other (income) expense, net






138 






- 






- 






(180) 






318 








 






 






 






 






 






 








First Quarter 2025







 






 






 






 








Cost of sales






$3,419 






$620 






$36 






$- 






$2,763 








Selling, general and administrative






2,552 






23 






- 






- 






2,529 








Research and development






3,621 






7 






- 






- 






3,614 








Restructuring costs






69 






- 






69 






- 






- 








Other (income) expense, net






(35) 






(3) 






- 






(107) 






75 







GAAP Expense, EPS and Related Information

Gross margin was 74.2% for the first quarter of 2026 compared with 78.0% for the first quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, higher restructuring costs, the recognition of inventory fair value step-up related to the 2025 Verona Pharma acquisition and the unfavorable impact of foreign exchange, partially offset by favorable product mix.


Selling, general and administrative (SG&A) expenses were $2.7 billion in the first quarter of 2026, an increase of 6% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.


Research and development (R&D) expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending, the unfavorable impact of foreign exchange and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBiotech Limited (EyeBio).


Other (income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities.


The income tax provision for the first quarter of 2026 was $709 million on a pretax loss of $3.5 billion, resulting in an effective income tax rate of (20.1)%. This effective income tax rate includes a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded.


GAAP loss per share was $1.72 for the first quarter of 2026 compared with earnings per share of $2.01 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.


Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 81.9% for the first quarter of 2026 compared with 82.2% for the first quarter of 2025. The decrease was primarily due to the unfavorable impact of foreign exchange, partially offset by favorable product mix.


Non-GAAP SG&A expenses were $2.7 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.


Non-GAAP R&D expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending and the unfavorable impact of foreign exchange, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBio.


Non-GAAP other (income) expense, net, was $318 million of expense in the first quarter of 2026 compared with $75 million of expense in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense.


The non-GAAP income tax provision for the first quarter of 2026 was $957 million on a pretax loss of $2.2 billion, resulting in a non-GAAP effective income tax rate of (43.5)%. This effective income tax rate includes a 57.6 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded.


Non-GAAP loss per share was $1.28 for the first quarter of 2026 compared with earnings per share of $2.22 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.


A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows.





First Quarter








$ in millions, except EPS amounts






2026 






2025 








EPS







 








GAAP EPS






$(1.72) 






$2.01 








Difference






0.44 






0.21 








Non-GAAP EPS that excludes items listed below3






$(1.28) 






$2.22 








 






 






 








Net (Loss) Income







 








GAAP net (loss) income2






$(4,240) 






$5,079 








Difference






1,084 






532 








Non-GAAP net (loss) income that excludes items listed below2,3






$(3,156) 






$5,611 








 






 






 








Excluded Items:







 








Acquisition- and divestiture-related costs4






$1,046 






$647 








Restructuring costs






466 






105 








Income from investments in equity securities






(180) 






(107) 








Increase to net loss / decrease to net income before taxes






1,332 






645 








Estimated income tax benefit5






(248) 






(113) 








Increase to net loss / decrease to net income






$1,084 






$532 







Pipeline and Portfolio Highlights

In the first quarter, the Company continued to advance its pipeline, achieving significant regulatory and clinical milestones across a broad range of therapeutic areas.



Oncology:


U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for the treatment of certain adults with PD-L1+ (combined positive score [CPS] ≥1) platinum-resistant ovarian cancer, based on Phase 3 KEYNOTE-B96 trial.


The European Commission (EC) also approved this KEYTRUDA regimen for this population.






In April, FDA approved a label update for KEYTRUDA QLEX based on results from Phase 2 MK-3475A-F11 trial, which evaluated patient-reported preference for subcutaneous administration of KEYTRUDA QLEX over intravenous administration of KEYTRUDA in participants with multiple tumor types.



In April, FDA granted priority review for ifinatamab deruxtecan (I-DXd) for certain adults with previously treated extensive-stage small cell lung cancer, based on Phase 2 Ideate-Lung01 trial. I-DXd is part of the Company’s collaboration with Daiichi Sankyo.


FDA set Prescription Drug User Fee Act (PDUFA) date of Oct. 10, 2026.






FDA accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for the adjuvant treatment of certain patients with RCC, based on the Phase 3 LITESPARK-022 trial.


FDA set PDUFA date of June 19, 2026.






FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial. Lenvima is being developed as part of a collaboration with Eisai Co., Ltd (Eisai).


FDA set PDUFA date of Oct. 4, 2026.






Announced positive results from Phase 3 KEYNOTE-B15 trial (also known as EV-304) demonstrating KEYTRUDA plus Padcev reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC) when given before and after surgery.


KEYNOTE-B15 is the sixth study demonstrating overall survival (OS) with a KEYTRUDA-based regimen in an earlier-stage cancer.






In April, FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for cisplatin-eligible patients with MIBC, based on the Phase 3 KEYNOTE-B15 trial.


FDA set PDUFA date of Aug. 17, 2026.






In a pre-specified interim analysis of the Phase 3 LITESPARK-012 study, compared to KEYTRUDA plus Lenvima, the triplet combination therapy of KEYTRUDA plus Lenvima plus WELIREG, as well as the combination of MK-1308A (an investigational fixed dose coformulation of KEYTRUDA and the anti-CTLA-4 antibody quavonlimab) plus Lenvima, did not show a statistically significant improvement in the primary endpoints of progression-free survival and OS in patients with advanced clear cell RCC.



In the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT), KEYTRUDA plus dCRT did not show a statistically significant improvement in the primary endpoint of EFS in certain patients with locally advanced unresectable esophageal carcinoma.



In a prespecified interim analysis of the Phase 3 KEYNOTE-866 study, compared to perioperative placebo plus neoadjuvant chemotherapy, perioperative KEYTRUDA plus neoadjuvant chemotherapy did not show a statistically significant improvement in the primary endpoint of EFS in patients with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection.







Vaccines and Infectious Diseases:


In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. IDVYNSO was also approved in Japan for these patients in March.



Presented data from three Phase 3 trials evaluating DOR/ISL at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI), including:


Results from Phase 3 MK-8591A-053 trial demonstrated that DOR/ISL is the first two-drug regimen that does not include an integrase strand transfer inhibitor to demonstrate non-inferiority and similar safety profile at Week 48 versus bictegravir/emtricitabine/tenofovir alafenamide6 [(50 mg/200 mg/25 mg) (BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment.



Results from the Phase 3 MK-8591A-052 and MK-8591A-051 trials demonstrated that DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other antiretroviral therapies, including BIC/FTC/TAF.






In April, EC approved ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season, based on Phase 2b/3 CLEVER and Phase 3 SMART trials.



Announced positive second RSV season results from Phase 3 SMART trial evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV disease over two RSV seasons.



European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion for an expanded indication for CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumococcal pneumonia in certain children and adolescents at increased risk of pneumococcal disease.







Cardiometabolic and Respiratory:


Presented new data at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26) including:


Positive results from Phase 3 CORALreef AddOn trial demonstrated significantly greater LDL-C reductions at eight weeks compared to guideline-recommended oral non-statin therapies when added to background statins. This is the third positive Phase 3 study of enlicitide.



Positive data from Phase 2 CADENCE trial provided definitive proof-of-concept for WINREVAIR in adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). Totality of evidence supports advancing development of WINREVAIR for this distinct patient population into a registrational Phase 3 study.










Animal Health:


FDA approved NUMELVI for dogs, the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older.







Business Development:


Announced an agreement to acquire Terns Pharmaceuticals, Inc. (Terns) through a subsidiary.


Expands hematology pipeline with the addition of TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with chronic myeloid leukemia (CML).



Transaction expected to close in May.









Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*




Oncology






KEYTRUDA and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, FDA Approved for Certain Adults With PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second- or Third-Line Treatment; Based on Results From Phase 3 KEYNOTE-B96 Trial








EC Approved KEYTRUDA Plus Paclitaxel ± Bevacizumab for Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment Regimens; Based on Results From Phase 3 KEYNOTE-B96 Trial 








I-DXd Granted Priority Review in U.S. for Adult Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer Who Experienced Disease Progression on or After Platinum-Based Chemotherapy; Based on Results From Phase 2 Ideate-Lung01 Trial; FDA Set PDUFA Date of Oct. 10, 2026








FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, for Cisplatin-Eligible Patients With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial; FDA Set PDUFA Date of Aug. 17, 2026








KEYTRUDA Plus Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Results From Phase 3 KEYNOTE-B15 Trial








KEYTRUDA Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of OS Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer; Results From Phase 3 KEYNOTE-B96 Trial








KEYTRUDA Plus WELIREG Given as Adjuvant Therapy Reduced Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage RCC; Results From Phase 3 LITESPARK-022 Trial; FDA Set PDUFA Date of June 19, 2026 for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX








WELIREG Plus Lenvima Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With RCC; Results From Phase 3 LITESPARK-011 Trial; FDA Set PDUFA Date of Oct. 4, 2026








The Company and Eisai Provided Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced RCC








Vaccines and

Infectious Diseases






FDA Approved the Company’s Once-Daily IDVYNSO for Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials








The Company Announced Late-Breaking Data From Three Phase 3 Trials Evaluating DOR/ISL, an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living With HIV-1, at CROI 2026








EC Approved ENFLONSIA for the Prevention of RSV Lower Respiratory Tract Disease in Infants During Their First RSV Season; Based on Results From Phase 2b/3 CLEVER and Phase 3 SMART Trials








The Company Announced Positive New Data for ENFLONSIA for Infants and Children Under 2 Years of Age at Increased Risk for Severe RSV Disease Over Two RSV Seasons; Results From Phase 3 SMART Trial








The Company Presented New Data Reinforcing Long-Term Efficacy of GARDASIL 9 and GARDASIL at the EUROGIN International Multidisciplinary HPV Congress 2026








Cardiometabolic and

Respiratory






Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins; Results From Phase 3 CORALreef AddOn Trial








Positive Data From Phase 2 CADENCE Trial Provided Definitive Proof-of-Concept for WINREVAIR in Adults With the Syndrome of CpcPH-HFpEF








Ophthalmology






The Company Initiated Pivotal Phase 2b/3 Trial Evaluating MK-8748, an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular Degeneration








Animal Health






FDA Approved NUMELVI for Dogs – First and Only Second-Generation JAK Inhibitor for the Control of Pruritus Associated With Allergic Dermatitis








Research






The Company and Mayo Clinic Announced New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine








The Company and Google Cloud Partnered To Accelerate Agentic AI Enterprise Transformation








*References to the Company’s name in the above news release titles have been modified for the purpose of this announcement.







Upcoming Investor Event

The Company will hold an Oncology Investor Event to coincide with the 2026 American Society of Clinical Oncology Annual Meeting on Monday, June 1, 2026, 6 p.m. CT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Chicago and will be accessible via live audio webcast at this weblink.


Full-Year 2026 Financial Outlook

The following table summarizes the Company’s full-year financial outlook.




 






Full Year 2026








 






Updated






Prior








Sales*






$65.8 billion to $67.0 billion






$65.5 billion to $67.0 billion








Non-GAAP Gross margin3






Approximately 82%






Approximately 82%








Non-GAAP Operating expenses3**






$36.0 billion to $36.8 billion






$35.9 billion to $36.9 billion








Non-GAAP Other (income) expense, net3






Approximately $1.3 billion expense






Approximately $1.3 billion expense








Non-GAAP Effective income tax rate3






23.5% to 24.5%






23.5% to 24.5%








Non-GAAP EPS3***






$5.04 to $5.16






$5.00 to $5.15








Share count (assuming dilution)






Approximately 2.48 billion






Approximately 2.48 billion








*The Company does not have any non-GAAP adjustments to sales.








**Includes a one-time charge of $9.0 billion for the acquisition of Cidara. Outlook does not reflect the proposed acquisition of Terns or assume any additional significant potential business development transactions.








***Includes a one-time charge of $3.62 per share for the acquisition of Cidara.







The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective income tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.


The Company now anticipates full-year 2026 sales to be between $65.8 billion and $67.0 billion, including a positive impact from foreign exchange of approximately 1% at mid-April 2026 exchange rates.


The Company continues to expect the full-year non-GAAP effective income tax rate to be between 23.5% and 24.5% including the impact of the non-tax-deductible one-time charge for the acquisition of Cidara.


The Company now expects full-year 2026 non-GAAP EPS to be between $5.04 and $5.16, including a positive impact from foreign exchange of approximately $0.10 per share at mid-April 2026 exchange rates. This range includes a one-time charge of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions.


In April 2026, the Company announced a tender offer to acquire Terns. The Company’s financial outlook does not reflect this transaction, which is expected to be accounted for as an asset acquisition and result in a one-time charge of approximately $5.8 billion, or approximately $2.35 per share. In addition, taking into consideration operational investment to advance TERN-701, as well as the cost of financing the transaction, the Company also anticipates EPS will be negatively impacted by approximately $0.12 over the remainder of 2026 following the close, which is expected in May.


The financial outlook does not assume additional significant potential business development transactions.


Earnings Conference Call

Investors, journalists and the general public may access a live audio webcast of the call on Thursday, April 30, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.


All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.


About Our Company

At Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.


Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.


Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.


The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).


Appendix

Generic product names are provided below.


Pharmaceutical

BRIDION (sugammadex)

CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)

ENFLONSIA (clesrovimab-cfor)

GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

IDVYNSO (doravirine/islatravir)

JANUMET (sitagliptin and metformin HCl)

JANUVIA (sitagliptin)

KEYTRUDA (pembrolizumab)

KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)

LAGEVRIO (molnupiravir)

Lenvima (lenvatinib)

Lynparza (olaparib)

M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)

OHTUVAYRE (ensifentrine)

PREVYMIS (letermovir)

PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)

VARIVAX (Varicella Virus Vaccine Live)

ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)

WELIREG (belzutifan)

WINREVAIR (sotatercept-csrk)


Animal Health

BRAVECTO (fluralaner)

NUMELVI (atinvicitinib tablets)



________________________________ 



1 Available in some markets as KEYTRUDA SC.








2 Net (loss) income attributable to the Company.








3 The Company is providing certain 2026 and 2025 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release.








4 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions.








5 Includes the estimated income tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented.








6 Bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY) is a registered trademark of Gilead Sciences, Inc.








(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)


(UNAUDITED)


Table 1


 





 





GAAP






 






% Change











 





 





1Q26






1Q25






 











 





 


 





 


Sales


$






16,286






 






$






15,529






 







5%








 





 





 


Costs, Expenses and Other





 








Cost of sales


 






4,195






 






 






3,419






 







23%








Selling, general and administrative


 






2,700






 






 






2,552






 







6%








Research and development


 






12,592






 






 






3,621






 







*








Restructuring costs


 






195






 






 






69






 







*








Other (income) expense, net


 






138






 






 






(35






)







*








(Loss) Income Before Taxes


 






(3,534






)






 






5,903






 







*








Income Tax Provision


 






709






 






 






818






 







 








Net (Loss) Income


 






(4,243






)






 






5,085






 







*








Less: Net (Loss) Income Attributable to Noncontrolling Interests


 






(3






)






 






6






 







 








Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA


$






(4,240






)






$






5,079






 







*








 





 





 


(Loss) Earnings per Common Share Assuming Dilution (1)


$






(1.72






)






$






2.01






 







*








 





 


Average Shares Outstanding Assuming Dilution (1)


 






2,472






 






 






2,531






 










Tax Rate


 






-20.1






%






 






13.9






%










 





 


* 100% or greater








 


(1) Because the Company recorded a net loss in the first quarter of 2026, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.




MERCK & CO., INC., RAHWAY, N.J., USA


FIRST QUARTER 2026 GAAP TO NON-GAAP RECONCILIATION


(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)


(UNAUDITED)


Table 2a


 





GAAP






 






Acquisition- and

Divestiture-Related

Costs (1)






 






Restructuring

Costs (2)






 






(Income) Loss

from Investments

in Equity Securities






 






Adjustment

Subtotal






 






Non-GAAP










 






 






 






 






 







First Quarter














Cost of sales


$






4,195






 







1,014






 







237






 









1,251






 







$






2,944






 







Selling, general and administrative


 






2,700






 







32






 











32






 







 






2,668






 







Research and development


 






12,592






 









34






 









34






 







 






12,558






 







Restructuring costs


 






195






 









195






 









195






 







 






–






 







Other (income) expense, net


 






138






 











(180






)







(180






)







 






318






 







Loss Before Taxes


 






(3,534






)







(1,046






)







(466






)







180






 







(1,332






)







 






(2,202






)







Income Tax Provision (Benefit)


 






709






 







(202






)






(3)






(85






)






(3)






39






 






(3)






(248






)







 






957






 







Net Loss


 






(4,243






)







(844






)







(381






)







141






 







(1,084






)







 






(3,159






)







Net Loss Attributable to Merck & Co., Inc., Rahway, N.J., USA


 






(4,240






)







(844






)







(381






)







141






 







(1,084






)







 






(3,156






)







Loss per Common Share Assuming Dilution (4)


$






(1.72






)







(0.34






)







(0.16






)







0.06






 







(0.44






)







$






(1.28






)



















 


Tax Rate


 






-20.1






%















 






-43.5






%







 











 


Only the line items that are affected by non-GAAP adjustments are shown.


The Company is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the Company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.


(1) Amounts included in cost of sales reflect expenses for the amortization of intangible assets, as well as the recognition of fair value step-up of inventories related to the 2025 Verona Pharma plc acquisition. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures.


(2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairment charges associated with facilities to be closed or divested, as well as contractual termination costs, associated with activities under the Company's formal restructuring programs.


(3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.


(4) Because the Company recorded a net loss in the first quarter of 2026, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.



MERCK & CO., INC., RAHWAY, N.J., USA


FRANCHISE / KEY PRODUCT SALES


(AMOUNTS IN MILLIONS)


(UNAUDITED)


Table 3


 









 




2026







2025






1Q




1Q

1Q
2Q
3Q
4Q
Full Year

Nom %
Ex-Exch %


TOTAL SALES (1)

$16,286







$15,529






$15,806






$17,276






$16,400






$65,011







5






3







PHARMACEUTICAL

14,349







13,638






14,050






15,611






14,843






58,142







5






2







Oncology












Keytruda

7,906







7,205






7,956






8,142






8,337






31,641







10






6







Keytruda Qlex

128









5






35






40







-






-







Alliance Revenue – Lynparza (2)

341







312






370






379






389






1,450







9






6







Alliance Revenue – Lenvima (2)

256







258






265






258






272






1,053







-1






-2







Welireg

199







137






162






196






220






716







45






43







Alliance Revenue – Reblozyl (3)

148







119






107






136






164






525







25






25







Vaccines (4)












Gardasil/Gardasil 9

1,069







1,327






1,126






1,749






1,031






5,233







-19






-22







ProQuad/M-M-R II/Varivax

538







539






609






684






619






2,451







-






-2







RotaTeq

206







228






121






204






119






673







-10






-11







Vaxneuvance

202







230






229






226






140






825







-12






-16







Capvaxive

142







107






129






244






279






759







33






31







Enflonsia

1









79






21






100







-






-







Cardiometabolic & Respiratory












Winrevair

525







280






336






360






467






1,443







88






87







Ohtuvayre

131










178






178







-






-







Alliance Revenue - Adempas/Verquvo (5)

109







106






123






112






129






470







3






3







Adempas (6)

78







68






80






82






83






312







15






5







Infectious Diseases












Bridion

472







441






461






439






499






1,841







7






7







Prevymis

272







208






228






266






275






978







31






26







Zerbaxa

82







70






74






81






87






312







17






14







Delstrigo

75







67






83






77






79






306







12






1







Isentress/Isentress HD

59







90






86






82






67






325







-34






-36







Dificid

34







83






96






43






25






247







-59






-59







Lagevrio

28







102






83






138






57






380







-73






-73







Diabetes












Januvia

367







549






372






382






302






1,604







-33






-33







Janumet

207







247






251






243






199






940







-16






-18







Other Pharmaceutical (7)

774







865






703






1,004






770






3,340







-11






-12







ANIMAL HEALTH

1,791







1,588






1,646






1,615






1,505






6,354







13






6







Livestock

1,064







924






961






1,023






987






3,896







15






8







Companion Animal

727







664






685






592






518






2,458







9






4







Other Revenues (8)

146







303






110






50






52






515







-52






4







 









 


Sum of quarterly amounts may not equal year-to-date amounts due to rounding.


 









 


(1) Only select products are shown.


(2) Alliance Revenue represents the Company's share of profits, which are product sales net of cost of sales and commercialization costs.


(3) Alliance Revenue represents royalties.


(4) Total Vaccines sales were $2,314 million and $2,607 million in the first quarter of 2026 and 2025, respectively.


(5) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.


(6) Net product sales in the Company's marketing territories.





(7) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million and $44 million in the first quarter of 2026 and 2025, respectively.


(8) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of milestone payments for out-licensed products were $132 million and $95 million in the first quarter of 2026 and 2025, respectively.


 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260430995314/en/
Media Contacts:
Michael Levey

michael.levey@msd.com
John Cummins

john.cummins2@msd.com
Investor Contacts:
Peter Dannenbaum

(732) 594-1579
Steven Graziano

(732) 594-1583


Original: Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones