Stoke Therapeutics and Biogen Present Long-Term Clinical Data that Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)September 3, 2026 7:30 PM
Business Wire –4-year data from the Phase 1/2a open-label extension (OLE) studies showed substantial and durable reductions in seizures and continuing improvements in cognition and behavior in patients treated with zorevunersen on top of standard of care anti-seizure medicines– –New data showed substantial reductions in the most severe seizure types, the leading risk factor for sudden unexpected death in epilepsy (SUDEP)– –Improvements in quality of life were demonstrated through 28 months of treatment– –Zorevunersen generally well tolerated, with some patients treated for more than 5 years– –Data from the global, pivotal Phase 3 EMPEROR study anticipated in Q3 2027 to complete the planned rolling U.S. NDA submission to the FDA– Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB) today announced presentations of data at the 16th European Epilepsy Congress (EEC), taking place September 5-9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Data presented at EEC represent more than 5 years of clinical experience with zorevunersen in patients with Dravet syndrome, including two Phase 1/2a and ongoing open-label extension studies (OLEs). Four-year OLE results showed substantial and durable reductions in seizures and continuing improvements in cognition and behavior. A new exploratory sub-analysis also showed substantial reductions in the most severe seizure types, which are the leading risk factor for sudden unexpected death in epilepsy (SUDEP)1. SUDEP is the primary cause of premature death in Dravet syndrome2, and up to 20% of children and adolescents with the disease die before reaching adulthood3. An additional sub-analysis presented at EEC demonstrated substantial improvements in quality of life through 28 months in the OLEs. Zorevunersen continues to be generally well tolerated in the OLEs. “Seizures are the most acute symptom of Dravet syndrome but the disease affects nearly every aspect of a child’s development, from their ability to communicate with loved ones to skills like dressing and feeding themselves,” said Helen Cross, MB ChB, Ph.D., Professor, The Prince of Wales’s Chair of Childhood Epilepsy and Director of University College London Great Ormond Street Institute of Child Health, Honorary Consultant in Paediatric Neurology at Great Ormond Street Hospital. “The continuing improvements in cognition and behavior shown in these studies suggest zorevunersen has the potential to narrow the developmental gap between these children and their neurotypical peers, helping them gain more independence and participate in experiences that many thought might never be possible. Taken together, the data from studies of zorevunersen offer hope for a very different future for people living with Dravet syndrome and their families.” The global, pivotal Phase 3 EMPEROR study is underway to evaluate the efficacy and safety of zorevunersen. Enrollment has completed in the planned primary analysis population, which will evaluate zorevunersen compared to sham administered via lumbar puncture (LP) in 162 patients enrolled in the U.S., U.K. and Japan. A Phase 3 data readout is anticipated in the third quarter of 2027 to complete the planned rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2027. Enrollment in Europe has also completed with 34 participants enrolled. Summary of Data from the Phase 1/2a and OLE Studies Presented at EEC 4-year OLE data: Following treatment in the Phase 1/2a studies, 93% (75/81) of eligible patients continued treatment in the OLEs. As of the 4-year data cutoff, 77% (58/75) of patients remained in these studies. Patients receiving zorevunersen on top of standard anti-seizure medicines (ASMs) continued to experience durable reductions in seizures and ongoing improvements in cognition and behavior. Statistically significant improvements in cognition and behavior were demonstrated at 1, 2, 3 and 4 years of treatment compared to OLE baseline. Severe seizure analysis: Patients with Dravet syndrome experience frequent, prolonged and refractory seizures. Compared with the general epilepsy population, patients with Dravet syndrome have a significantly increased risk of SUDEP2. Seizures are classified based on severity, with generalized tonic-clonic (GTC), focal-to-bilateral tonic-clonic (focal-to-BTC) and tonic-clonic seizures of unknown origin considered the most severe and correlated with the highest morbidity and mortality in people with epilepsy1. Substantial reductions in GTC and focal-to-BTC seizures were demonstrated through 3 years of the OLEs, compared to Phase 1/2a baseline, in patients treated with zorevunersen on top of standard of care ASMs. Quality of life analysis: Patients experienced substantial improvements in quality of life through 28 months in the OLEs, compared to Phase 1/2a baseline, as measured by EuroQol Visual Analog Scale (EQ-VAS, a component of the Euro-Qol-5D Youth). EQ-VAS is a validated measure of overall health status ranging from 0 to 100 (worst to best imaginable health) and provides insight into the real-world impact of zorevunersen on patients with Dravet syndrome and their families. “Up to 20% of children and adolescents with Dravet syndrome die before reaching adulthood, and SUDEP is the primary cause,” said Barry Ticho, M.D., Ph.D., Chief Medical Officer of Stoke Therapeutics. “These data are especially meaningful because they show substantial reductions in the severe seizures most strongly correlated with SUDEP and demonstrate continuing improvements in the debilitating neurodevelopmental aspects of the disease. Together with ongoing improvements in quality of life, these data increase our confidence in what zorevunersen may one day deliver for the Dravet community.” “For patients with a chronic disease like Dravet syndrome, safety and tolerability are critically important,” said Stephanie Fradette, Pharm.D., Head of the Rare Neurology Development Unit at Biogen. “The ongoing open-label extension studies will continue to grow the body of evidence shaping our understanding of zorevunersen’s long-term safety as well as its potential to address the underlying genetic cause of Dravet syndrome and improve outcomes for patients. We look forward to results from the Phase 3 EMPEROR study next year.” Summary of Zorevunersen Safety Data Zorevunersen continues to be generally well tolerated, with some patients treated for more than 5 years in the Phase 1/2a and ongoing OLE studies. As of July 31, 2026, more than 930 doses have been administered. Elevated CSF protein lab values occurred in approximately 94% of patients, of which 59% have been classified as a treatment-emergent adverse event. Importantly, no serious or severe clinical manifestations have been associated with CSF protein elevations. There have been no reports of hydrocephalus. About Dravet Syndrome Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57 percent of patients with Dravet syndrome do not achieve ≥50 percent reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20 percent of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures, seizure-related accidents or infections3. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan4. There are no approved disease-modifying therapies for people living with Dravet syndrome. About Zorevunersen Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1 protein production in brain cells from the unaffected (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function in the SCN1A gene, and China’s Center for Drug Evaluation has granted zorevunersen Breakthrough Therapy Designation. Stoke has a strategic collaboration with Biogen (Nasdaq: BIIB) to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. Zorevunersen is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. About the Phase 1/2a and Open-Label Extension Studies Two Phase 1/2a open-label, multicenter studies evaluated the effects of zorevunersen in patients with highly refractory Dravet syndrome ages 2 to 18 years (N=81). Primary endpoints were the safety profile, plasma pharmacokinetics (PK) and exposure in cerebrospinal fluid (CSF) of single and multiple doses of zorevunersen. Secondary endpoints included percentage change from baseline in major motor seizure frequency, overall clinical status (a measure of patients’ overall functioning) and quality of life. The ADMIRAL Phase 1/2a study included an exploratory endpoint to evaluate changes in neurodevelopmental status (cognition & behavior) as measured by Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). The Phase 1/2a studies were completed in November 2023. Following treatment in the Phase 1/2a studies, eligible patients continued treatment with zorevunersen every four months in one of two OLEs. There was at least a 6-month gap between the last dose administered in the Phase 1/2a studies and the first dose administered in the OLEs. The primary endpoints are the safety profile of multiple doses of zorevunersen. Secondary endpoints include PK parameters, percentage change from baseline in major motor seizure frequency, change in overall clinical status, and change from baseline in quality of life. Exploratory endpoints include changes in neurodevelopment status as measured by Vineland-3. Results from the Phase 1/2a and OLE studies were published in The New England Journal of Medicine (NEJM) in March 2026. The OLE studies are ongoing. About the Phase 3 EMPEROR Study The Phase 3 EMPEROR Study (NCT06872125) is a global, double-blind, sham-controlled study evaluating the efficacy, safety and tolerability of zorevunersen in children ages 2 to

Stoke Therapeutics and Biogen to present four-year zorevunersen data at epilepsy congressSeptember 1, 2026 10:00 AM
IH Market News Stoke Therapeutics (NASDAQ:STOK) and Biogen (NASDAQ:BIIB) said they will present clinical data for zorevunersen, their investigational treatment for Dravet syndrome, at the 16th European Epilepsy Congress in Athens, Greece, from September 5 to 9. The presentations will include the first disclosure at a medical meeting of four-year results from ongoing Phase 1/2a open-label extension studies. According to the companies, improvements in cognition and behaviour were sustained through four years alongside reductions in seizures and a generally well-tolerated safety profile. New sub-analyses will also examine the treatment’s effects on the most severe seizure types and patient quality of life. These findings are based on company-reported clinical data and zorevunersen remains investigational. Majority of patients remain in extension studies A total of 81 patients were enrolled in the Phase 1/2a studies, with 93% subsequently continuing into one of two open-label extension studies. At the four-year data cutoff, 77% of those patients remained enrolled. More than 930 doses of zorevunersen had been administered as of July 31, 2026. Elevated cerebrospinal fluid protein levels were observed in approximately 94% of patients, with 59% classified as treatment-emergent adverse events. According to Stoke and Biogen, no serious clinical manifestations or cases of hydrocephalus were reported. The clinical significance of the reported findings remains subject to further evaluation, including results from ongoing late-stage development. Zorevunersen targets the SCN1A gene Zorevunersen is an antisense oligonucleotide designed to increase production of functional NaV1.1 protein by targeting the unaffected copy of the SCN1A gene. Mutations in SCN1A are associated with most cases of Dravet syndrome. The investigational therapy has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, as well as orphan drug designation from both the FDA and the European Medicines Agency. These designations are intended to support the development of qualifying treatments and do not constitute regulatory approval. Phase 3 EMPEROR study underway Stoke Therapeutics and Biogen are currently evaluating zorevunersen in the global Phase 3 EMPEROR study, with results anticipated in the third quarter of 2027. The timing represents the companies’ current expectation and remains subject to the progress of the clinical trial. Under the companies’ collaboration agreement, Stoke retains commercialization rights for zorevunersen in the United States, Canada and Mexico, while Biogen holds exclusive rights in the rest of the world. Zorevunersen has not been approved by any regulatory authority, and its safety and efficacy remain under clinical investigation. Stoke Therapeutics stock price Biogen stock priceThe post Stoke Therapeutics and Biogen to present four-year zorevunersen data at epilepsy congress appeared first on US Editors. Original: Stoke Therapeutics and Biogen to present four-year zorevunersen data at epilepsy congress

Stoke Therapeutics and Biogen Announce Presentations of Clinical Data from Studies of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)September 1, 2026 7:30 AM
Business Wire –4-year data from the Phase 1/2a open-label extension (OLE) studies support the potential disease-modifying effects of zorevunersen– –Improvements in cognition and behavior sustained through 4 years, in addition to durable seizure reductions and a generally well-tolerated safety profile– –New data from sub-analyses of patients treated with zorevunersen in the Phase 1/2a OLEs include effects on severe seizures and quality of life– Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB) today announced presentations of data at the 16th European Epilepsy Congress (EEC), taking place September 5-9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. The global, pivotal Phase 3 EMPEROR study is underway to evaluate the safety and efficacy of zorevunersen, and results are anticipated in the third quarter of 2027. Data to be shared at EEC include the first medical meeting presentation of 4-year results from the ongoing Phase 1/2a open-label extension (OLE) studies of zorevunersen in patients with Dravet syndrome. Improvements in cognition and behavior were sustained through 4 years, in addition to durable seizure reductions and a generally well-tolerated safety profile. New exploratory sub-analyses show effects on the most severe seizure types, which are the leading risk factor for sudden unexpected death in epilepsy (SUDEP)1, as well as improvements in quality of life for patients treated with zorevunersen. "Together with the Phase 1/2a results, the ongoing OLE studies provide more than 5 years of clinical data that continue to deepen our understanding of zorevunersen’s long-term safety and benefits,” said Barry Ticho, M.D., Ph.D., Chief Medical Officer of Stoke Therapeutics. “These data have consistently shown substantial and durable seizure reductions with continued treatment. For the first time at EEC, we will share an additional analysis showing zorevunersen’s effects on the most severe seizure types. Alongside continuing improvements in cognition and behavior over time, these new findings support the potential of zorevunersen to change the course of Dravet syndrome by targeting the underlying genetic cause of the disease.” “Dravet syndrome is a devastating neurodevelopmental disease that impacts nearly every aspect of daily life for patients and those who care for them,” said Stephanie Fradette, Pharm.D., Head of the Rare Neurology Development Unit at Biogen. “The data shared at EEC provide continued support for the potential of zorevunersen to give people living with Dravet syndrome the possibility of more neurotypical development. We look forward to discussing these data with the epilepsy community at EEC.” Details of the EEC presentations are as follows: Title: Zorevunersen Demonstrates Disease-Modifying Potential in Patients with Dravet Syndrome with Improvements in Seizure Burden, Quality of Life, and Overall Clinical Status
Oral Presentation Date & Time: Sunday, September 6, 12:53-1:02 PM EEST/ UTC+3 (5:53-6:02 AM ET)
Oral Presenter: J. Helen Cross, MB ChB, Ph.D., Professor, The Prince of Wales’s Chair of Childhood Epilepsy and Head of the Developmental Neuroscience Programme at University College London Great Ormond Street Institute of Child Health, Honorary Consultant in Paediatric Neurology and Past President of the International League Against Epilepsy Title: Zorevunersen Demonstrates Potential as a Disease-Modifying Therapy in Patients with Dravet Syndrome: A Matching-Adjusted Indirect Comparison Between Natural History and Patients Receiving Zorevunersen
Poster Presentation Date & Time: Monday, September 7, 2:00-3:00 PM EEST/ UTC+3 (7:00-8:00 AM ET)
Poster Presenter: Andreas Brunklaus, MD, Consultant Paediatric Neurologist at the Royal Hospital for Children in Glasgow, Honorary Professor at the University of Glasgow
Poster Number: P0803 Title: Zorevunersen Demonstrates Potential as a Disease-Modifying Therapy in Patients with Dravet Syndrome Through Durable Seizure Reduction and Improvements in Cognition, Behavior, and Quality of Life Through 48 Months of Treatment in Open-Label Extension Studies
Poster Presentation Date & Time: Tuesday, September 8, 2:00-3:00 PM EEST/ UTC+3 (7:00-8:00 AM ET)
Poster Presenter: Elaine Wirrell?, MD, Director of Pediatric Epilepsy at Mayo Clinic, Director of the Child and Adolescent Neurology Residency Training Program at Mayo Clinic
Poster Number: P0797 Summary of Zorevunersen Safety Data Following treatment in the Phase 1/2a studies, 93% (75/81) patients continued treatment in one of two OLE studies. As of the 4-year data cutoff, 77% (58/75) patients remained in these studies. Zorevunersen continues to be generally well tolerated, with some patients treated for more than 5 years in the Phase 1/2a and ongoing OLE studies. As of July 31, 2026, more than 930 doses have been administered. Elevated CSF protein lab values occurred in approximately 94% of patients of which 59% have been classified as a treatment-emergent adverse event. Importantly, no serious or severe clinical manifestations have been associated with CSF protein elevations. There have been no reports of hydrocephalus. About Dravet Syndrome
Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57 percent of patients with Dravet syndrome do not achieve ≥50 percent reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20 percent of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures, seizure-related accidents or infections 2. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan 3. There are no approved disease-modifying therapies for people living with Dravet syndrome. About Zorevunersen
Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1 protein production in brain cells from the unaffected (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function in the SCN1A gene, and China’s Center for Drug Evaluation has granted zorevunersen Breakthrough Therapy Designation. Stoke has a strategic collaboration with Biogen (Nasdaq: BIIB) to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. Zorevunersen is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. About the Phase 1/2a and Open-Label Extension Studies
Two Phase 1/2a open-label, multicenter studies evaluated the effects of zorevunersen in patients with highly refractory Dravet syndrome ages 2 to 18 years (N=81). Primary endpoints were the safety profile, plasma pharmacokinetics (PK) and exposure in cerebrospinal fluid (CSF) of single and multiple doses of zorevunersen. Secondary endpoints included percentage change from baseline in major motor seizure frequency, overall clinical status (a measure of patients’ overall functioning) and quality of life. The ADMIRAL Phase 1/2a study included an exploratory endpoint to evaluate changes in neurodevelopmental status (cognition & behavior) as measured by Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). The Phase 1/2a studies were completed in November 2023. Following treatment in the Phase 1/2a studies, eligible patients continued treatment with zorevunersen every four months in one of two OLEs. There was at least a 6-month gap between the last dose administered in the Phase 1/2a studies and the first dose administered in the OLEs. The primary endpoints are the safety profile of multiple doses of zorevunersen. Secondary endpoints include PK parameters, percentage change from baseline in major motor seizure frequency, change in overall clinical status, and change from baseline in quality of life. Exploratory endpoints include changes in neurodevelopment status as measured by Vineland-3. Results from the Phase 1/2a and OLE studies were published in The New England Journal of Medicine (NEJM) in March 2026. The OLE studies are ongoing. About Stoke Therapeutics
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ or follow us on LinkedIn. About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, Instagram, LinkedIn, X, YouTube. Stoke Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the ability of zorevunersen to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior and cognition at the indicated dosing levels or at all; the potential benefits, safety and efficacy of zorevunersen; the design, timing and expected progress of clinical trials, data readouts, regulatory meetings, regulatory decisions and other presentations; and the participation of scientists associated with Stoke making presentations at EEC and the presentation of data at EEC. Statements including words such as “plan,” “potential,” “will,” “continue,” “expect,” or similar words and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause Stoke’s results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: Stoke’s ability to advance, obtain regulatory approval and ultimately commercialize its product candidates; that if Biogen were to breach or terminate the collaboration, Stoke would not obtain the anticipated financial or other benefits; the possibility that Stoke and Biogen may not be successful in their development of zorevunersen and that, even if successful, they may be unable to successfully commercialize zorevunersen; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; Stoke’s ability to protect its intellectual property; Stoke’s ability to fund development activities and achieve development goals into 2028; and the other risks and uncertainties described under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2025, its quarterly reports on Form 10-Q, and the other documents it files with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Stoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Biogen Safe Harbor
This news release contains forward-looking statements, including, among others, relating to: the potential clinical effects of zorevunersen; the potential for zorevunersen to change the course of Dravet syndrome and improve outcomes for patients; the expected timing of Phase 3 study results; the potential benefits, safety and efficacy of zorevunersen; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of the underlying causes of Dravet syndrome; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with Stoke Therapeutics; the potential of Biogen's commercial business and pipeline programs, including zorevunersen; and risks and uncertainties associated with drug development and commercialization. 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Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Biogen Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors. References: Beniczky, S. et al. Updated classification of epileptic seizures: Position paper of the International League Against Epilepsy. Epilepsia. 2025; 1804–1823. Symonds, J. et al. Early childhood epilepsies: epidemiology, classification, aetiology, and socio-economic determinants. Brain. 2021;144(9):2879-2891. Based on Stoke Therapeutics’ preliminary estimates, which scaled annual incidence to prevalence using country-specific live birth rates over the past 85 years and adjusted for Dravet-specific mortality. The estimate is based on incidence rates published by Wu et al., Pediatrics, 2015.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260901006975/en/ Stoke Media & Investor Contacts:
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+1 781 464 2442 Original: Stoke Therapeutics and Biogen Announce Presentations of Clinical Data from Studies of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 16th European Epilepsy Congress (EEC)

LEQEMBI IQLIK®(lecanemab-irmb) Autoinjector for Initiation of Therapy Now Available in the U.S. for Early Alzheimer's DiseaseAugust 24, 2026 8:00 AM
PR Newswire (US) LEQEMBI IQLIK is the first-of-its-kind anti-amyloid treatment worldwide offering at-home dosing
for initiation and maintenance (approved in the U.S.)TOKYO and CAMBRIDGE, Mass., Aug. 24, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that once weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) is now available in the U.S. for initiation therapy for early Alzheimer's disease (AD) in adults with mild cognitive impairment (MCI) or mild dementia due to AD, collectively referred to as early AD. MCI due to AD is the earliest symptomatic stage of AD and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words.1  LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two consecutive 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous (SC) treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as SC injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration.Expanding Treatment Convenience and Flexibility Across the Alzheimer's Disease Care Pathway
The availability of LEQEMBI IQLIK for both initiation and maintenance therapy in the U.S. enhances treatment convenience and flexibility, offering early AD patients and their care partners more control in managing their care while lowering barriers to initiating and continuing treatment with LEQEMBI. LEQEMBI IQLIK may reduce the time spent receiving anti-amyloid therapy via IV infusions. In addition, at-home administration allows patients and their care partners to continue treatment without the burden of clinic visits, making it easier to go out and travel. LEQEMBI IQLIK also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring. These features may help streamline the overall AD treatment pathway. For ARIA monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation.Support Resources for LEQEMBI IQLIK
Eisai and Biogen will provide a range of resources to help patients, care partners, healthcare providers, health systems and pharmacies successfully implement and use LEQEMBI IQLIK.Patient Support
Resources include an Instructions for Use (IFU) video and IQLIK Welcome Kit. The IQLIK Welcome Kit provides a What to Expect Treatment Tracker, an injection reminder magnet, and a Demo Kit to help patients and care partners understand what to expect, prepare for at-home injections, and administer injections safely at home. The LEQEMBI Companion® app will also be available. It brings the information patients and care partners need into one experience, including education about the injection process and tools for tracking each dose.Patients initiating IQLIK will be encouraged to bring the Welcome Kit to their initial dosing appointment. Kits will be available through: The LEQEMBI Specialty Pharmacy Network (CareMed Specialty Pharmacy and Walgreens Specialty Pharmacy)  Integrated Delivery Networks (IDNs) or the prescribing physician LEQEMBI Companion® - a program?offering financial support information and options for eligible patients.  Through the LEQEMBI Specialty Pharmacy Network, patients may receive support with prescription fulfillment, insurance coverage navigation, onboarding, delivery coordination, device-use education, and – if they choose to participate – treatment reminders and educational support during the first six months of therapy. Patients using other eligible specialty pharmacies may have access to similar support, which may vary by pharmacy.Healthcare Provider Resources
Electronic Health Record (EHR) support materials and a step-by-step Getting Started Guide will help providers navigate the process from prescription submission through therapy initiation.Financial Assistance
To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria.*The LEQEMBI Companion app was developed to deliver behavior-driven digital support for patients and care partners along their treatment journey, in partnership with Medisafe Ltd., a behavioral patient engagement engine built for complex and specialty therapies. Patients can visit LEQEMBI.com/CompanionAppSignUp to get started.Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.INDICATION
LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.IMPORTANT SAFETY INFORMATIONWARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)•Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.
•Apolipoprotein E e4 (ApoE e4) Homozygotes: Patients who are ApoE e4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA.•Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.WARNINGS AND PRECAUTIONSAMYLOID-RELATED IMAGING ABNORMALITIES
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.Risk Factors of ARIA and ICHApoE e4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE e4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE e4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE e4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE e4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers.Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE e4 allele is also associated with CAA.The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE e4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE e4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.HYPERSENSITIVITY REACTIONSHypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.INFUSION-RELATED REACTIONS (IRRs)IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.ADVERSE REACTIONSThe most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)The safety profile of subcutaneous LEQEMBI was similar to intravenous infusion. Subcutaneous dosing was associated with mostly localized (erythema, induration, swelling, heat, pain, pruritus, rash, ecchymosis, nodule, and hematoma) and less frequent systemic (headache, chills, fever, and fatigue) injection-related reactions, majority at first dose when initiating therapy. Localized reactions that were recurrent and/or delayed were observed. Severe localized reactions and cases leading to dose discontinuation or interruption occurred.LEQEMBI (lecanemab-irmb) is available:Intravenous infusion: 100 mg/mLSubcutaneous injection: 200 mg/mLPlease see full Prescribing Information for LEQEMBI, including Boxed WARNING.Click here to access the LEQEMBI digital library with assets available for download.MEDIA CONTACTS
Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120  Biogen Inc.Madeleine Shin +1-781-464-3260public.affairs@biogen.com  Eisai Europe, Ltd. EMEA Communications Department+44 (0) 7760 619251Emea-comms@eisai.net


Eisai Inc. (U.S.)Julie Edelman+1-862-213-5915Julie_Edelman@eisai.com 


INVESTOR CONTACTS
Eisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Tim Power+ 1-781-464-2442IR@biogen.comNotes to EditorsAbout lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).Lecanemab has been approved in 53 countries and regions including Japan, the U.S., China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the United States in July 2026, and applications are under review in four countries, including Japan and China. In China, the application has been granted Priority Review designation. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List," recently introduced by the National Healthcare Security Administration (NHSA) of China.LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's global placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Clarity AD evaluated lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897). 95% of patients who completed the core study (18 months) chose to continue in the long-term extension study (LTE), with 478 patients still receiving treatment for four years. In the Clarity AD core clinical study, data showed LEQEMBI IV significantly slowed disease progression at 18 months (27% vs placebo), and the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale.To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person's ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.LEQEMBI also rapidly reduced plaque as early as three months (-59.1 CL difference vs placebo in amyloid level at 18 months; P

Biogen Beats Second-Quarter Expectations as Growth Portfolio Drives Revenue HigherJuly 29, 2026 8:16 AM
IH Market News Biogen (NASDAQ:BIIB) reported stronger-than-expected second-quarter results on Wednesday, with revenue and adjusted earnings exceeding Wall Street forecasts as its expanding portfolio of growth products continued to offset weakness in its legacy multiple sclerosis business. The biotechnology company posted revenue of $2.74 billion for the quarter, an increase of 3% from a year earlier and well above Bloomberg’s consensus estimate of $2.47 billion. Product revenue rose 2% to $1.92 billion, comfortably exceeding analysts’ expectations of $1.77 billion. Adjusted earnings came in at $3.60 per share, down from $5.47 in the prior-year period but ahead of the consensus estimate of $2.89. Growth Portfolio Becomes Largest Business Biogen said revenue from its Growth Portfolio increased 24% year over year to $1.06 billion, supported by continued momentum from recently acquired products. The company noted that its Growth Portfolio generated more revenue during the quarter than its long-established multiple sclerosis franchise, highlighting the ongoing transformation of its business. Leqembi Sales Continue to Grow Global in-market sales of Alzheimer’s treatment Leqembi increased 15% from a year earlier to $184 million, although the figure came in slightly below analysts’ expectations of $186.4 million. In the United States, in-market sales reached $97 million, reflecting continued sequential growth. During the quarter, the U.S. Food and Drug Administration also approved Leqembi IQLIK for at-home treatment initiation, expanding access to the therapy. Demand Supports Growth Across Key Products Among Biogen’s other growth medicines, Spinraza generated revenue of $402 million, up 2% year over year, supported by demand for the high-dose regimen and customer stocking activity, partially offset by shipment timing in certain international markets. Revenue from Skyclarys increased 29% to $168 million, driven by stronger global demand, while Zurzuvae sales climbed 53% to $71 million as adoption continued to expand. Meanwhile, Vumerity revenue declined 7% to $197 million, primarily reflecting inventory-related dynamics. Company Raises Underlying Earnings Outlook Biogen updated its financial outlook for 2026, citing improving underlying business performance. The company increased its forecast for underlying non-GAAP diluted earnings per share to a range of $15.85 to $16.85, compared with its previous guidance of $15.25 to $16.25. Reported non-GAAP diluted earnings per share guidance was revised to between $12.00 and $13.00 to reflect acquisition-related expenses and milestone payments. Biogen also said it expects full-year 2026 revenue to increase by a mid-single-digit percentage compared with 2025. Biogen stock priceThe post Biogen Beats Second-Quarter Expectations as Growth Portfolio Drives Revenue Higher appeared first on US Editors. Original: Biogen Beats Second-Quarter Expectations as Growth Portfolio Drives Revenue Higher

Synapticure Launches Groundbreaking Ataxia Care Program, Expanding Access to Specialized Neurology NationwideJuly 16, 2026 7:47 AM
PR Newswire (US) Virtual-first, multidisciplinary care model delivers care for adults living with ataxias, connecting them to expert neurologist options nationwide. CHICAGO, July 16, 2026 /PRNewswire/ -- Synapticure, a leading virtual care company dedicated to improving access and outcomes for patients and caregivers living with neurodegenerative diseases, today announced the launch of a virtual ataxia care program. This program can help to provide timely access to specialized care for adults living with ataxias — a group of neurological conditions characterized by progressive loss of coordination, balance, and motor function. Synapticure partnered with Biogen Inc. (Nasdaq: BIIB) to support disease education and awareness efforts of this resource, helping to address a critical gap in access to care for the ataxia community. Biogen is not involved in developing, administering, or responsible for the Synapticure healthcare services, clinical considerations, or patient care. Adults with ataxias can receive specialized neurological care from Synapticure's care team or be co-managed alongside their existing care team. With this expansion, Synapticure adds to its comprehensive virtual platform for neurodegenerative care in the United States, now extending its reach to serve individuals living with ataxias across the country."For people living with ataxias and their families, accessing expert neurological care is often a years-long struggle," said Sandra Abrevaya, CEO and Co-Founder of Synapticure. "Synapticure was built to change that dynamic — to expand access to specialized neurological expertise directly to patients where they live, and to make personalized, proactive care the standard rather than the exception. We are proud to now open our doors to the ataxia community." Ataxias affect tens of thousands of people in the United States1. With a growing landscape of disease-modifying research, the need for informed, ataxia-knowledgeable care has never been greater. "Highly specialized ataxia care and expertise can be difficult to find locally, posing a significant challenge for individuals and families," said Kristen Fortino, Head of the U.S. Rare Disease Franchise at Biogen. "Our commitment to people living with rare neurological diseases, including the broader ataxia community, extends beyond treatment. We are dedicated to providing meaningful support every step of the care journey including supporting greater awareness of available care resources."Synapticure's ataxia care program will be led by Dr. Elizabeth Ferluga, MD, Director of Movement Disorders at Synapticure, who brings deep clinical expertise in movement disorders and a longstanding commitment to rare neurological conditions. Dr. Ferluga and the Synapticure clinical team can provide patients with access to specialized evaluations, genetic counseling, and comprehensive longitudinal care — all delivered virtually by Synapticure's independent healthcare providers. "Patients with ataxias are a community that has been underserved by the traditional healthcare system for far too long," said Dr. Elizabeth Ferluga, MD, Director of Movement Disorders at Synapticure. "The Synapticure model is transformative for this population — we can meet patients where they are, perform a thorough evaluation, help them understand their diagnosis and what it means for them and their families, provide information about potential clinical trials, and be a consistent, knowledgeable partner in their care over time. I am incredibly excited to bring this level of support to the ataxia community."Synapticure's ataxia care program can provide patients with: Virtual medical evaluations with independent neurologists trained in movement disorders, including ataxiasAt-home genetic testing, where appropriate, including pre and post-test counseling by Synapticure's certified genetic counselorsCoordinated evaluation of acquired causes of ataxias including comprehensive laboratory testing, brain imaging, and EMG/NCS as indicatedReview of current medications and discussion of evidence-based treatment optionsEducation about clinical trials studying ataxias and general guidance on how patients may explore participationCoordination with physical, occupational, and speech therapists, as well as other members of a patient's care team as appropriate and with patient consent Behavioral health support and caregiver resources to help families manage the full impact of receiving a neurological diagnosis As with all conditions Synapticure providers can treat, Synapticure can serve as a patient's primary neurologist, where permitted or work in collaboration with other physicians on a patient's existing care team. The Synapticure model is designed to complement, not replace, any existing specialist relationships a patient may have. Synapticure operates independently and is solely responsible for its clinical services and patient care.Patients living with ataxias anywhere in the United States can visit synapticure.com/with/ataxia or call (708) 630-1534 to schedule an intake appointment or learn more about Synapticure's services. About SynapticureFounded by Sandra Abrevaya, Brian Wallach, Peter Wallach, and Jason Langheier, Synapticure is a patient- and caregiver-founded virtual care provider offering access to expert neurologists, cutting-edge treatments and trials, wraparound care coordination, and behavioral health support in all 50 states. Partnering with providers and health plans, including CMS' GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases like Alzheimer's, Parkinson's, ALS, and now ataxias. For more information, visit www.synapticure.com. Synapticure's medical group, CareND, is in-network with Medicare and various commercial insurance plans, with new payer agreements added regularly. Where CareND is not yet in-network, claims will be submitted as an out-of-network provider. The Synapticure billing team is committed to cost transparency, providing patients with a cost estimate prior to any visit. Patients without insurance or those who prefer to pay out of pocket will be informed of visit costs in advance. Coverage and out-of-pocket costs vary based on a patient's health plan and individual circumstances.Media Contactmarketing@synapticure.com References: 1. National Ataxia Foundation. What is Ataxia? Available at: https://www.ataxia.org/what-is-ataxia/. Last accessed: May 2026. View original content to download multimedia:https://www.prnewswire.com/news-releases/synapticure-launches-groundbreaking-ataxia-care-program-expanding-access-to-specialized-neurology-nationwide-302826696.htmlSOURCE Synapticure Original: Synapticure Launches Groundbreaking Ataxia Care Program, Expanding Access to Specialized Neurology Nationwide

LEQEMBI® Real-World LEADER Study Presented at AAIC® 2026 Finds Over 75% of Early Alzheimer's Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of TreatmentJuly 14, 2026 11:15 AM
PR Newswire (US) Real-World Findings Support Long-Term Benefits of Continuous Treatment with LEQEMBI and Provide Important Insights into Treatment Experience Outside of a Clinical Trial SettingTOKYO and CAMBRIDGE, Mass., July 14, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study show that nearly 83% of early Alzheimer's disease (AD) patients enrolled in the study remained stable (75.9%) or improved (6.6%) while receiving LEQEMBI® therapy over an average of 17 months. The results were consistent across sex, race, ethnicity and APOE genotype. The data was presented during the "Developing Topics Session #3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings" at the Alzheimer's Association International Conference® (AAIC®) 2026 in London and online. AD is a chronic, progressive disease that requires ongoing treatment. LEQEMBI targets the underlying pathology of the disease and works in two ways throughout treatment - by removing insoluble (plaque) and soluble amyloid beta (protofibrils), helping to slow cognitive decline and loss of daily functioning. Data show continued treatment with LEQEMBI may be able to help keep patients in early AD for longer. Early AD includes mild cognitive impairment (MCI) due to AD and mild AD dementia.LEADER Study Design
The three-year LEADER Study is a multicenter, retrospective real-world study designed to examine LEQEMBI utilization, treatment persistence, transition to maintenance therapy, safety, cognitive and functional assessments, and healthcare professional (HCP) implementation learnings in diverse U.S. clinical settings for patients with early Alzheimer's disease (AD). The study integrated deidentified chart and electronic medical record (EMR) data from 13 U.S. sites, HCP surveys and HCP interviews. This interim analysis included 432 patients with early AD who received at least seven LEQEMBI infusions as of May 2026.Patient Characteristics at BaselineMean age: 74 yearsFemale Patients: 55.8% Disease Stage at BaselineMild cognitive impairment (MCI) due to AD: 63.9%Mild AD dementia: 36.1%.TreatmentThe mean duration of LEQEMBI treatment was 520 days.The mean number of LEQEMBI doses was 26.Change in disease stage was defined as:Stable: Patient remaining in the same disease stage (MCI due to AD or mild AD dementia) from baseline throughout the course of LEQEMBI treatment.Improvement: Patient transitioning from mild AD dementia at baseline to MCI due to AD over the course of LEQEMBI treatment.Progression: Patient advancing from MCI at baseline to mild/moderate AD dementia or from mild AD dementia at baseline to moderate AD dementia throughout the course of LEQEMBI treatment.LEADER Study Key Findings
Real-World Evidence Shows Long-Term Benefit with Continuous LEQEMBI Treatment Across Sex, Race, Ethnicity and APOE GenotypeOverall Study Population FindingsOf the 432 participants enrolled in the LEADER Study, disease stage could be evaluated in 427. Among these patients with early Alzheimer's disease, 82.5% remained stable or improved while receiving LEQEMBI, with consistent results across sex, race, ethnicity, and APOE genotype groups.75.9% remained stable compared with baseline, meaning they remained in the same disease stage throughout treatment.6.6% improved from baseline, moving from mild AD dementia to MCI due to AD.Nearly 87% of patients chose to remain on LEQEMBI treatment.In analyses by APOE e4 status, clinician-evaluated stable or improved disease stage was observed in:81.7% of APOE e4 heterozygotes (stable: 73.8%; improved: 7.9%)81.0% of APOE e4 homozygotes (stable: 75.9%; improved: 5.2%).Maintenance Dosing Population FindingsOf the 432 participants in the LEADER Study, 155 transitioned to once-every-four-weeks intravenous (IV) maintenance treatment, and 14 transitioned to once-weekly subcutaneous (SC) maintenance treatment.Among the 155 participants who transitioned to IV maintenance therapy, nearly 81% remained stable (72.3%) or improved (8.4%).Of the 14 patients who transitioned to SC maintenance treatment, 12 (85.7%) maintained their disease stage.Real-World Safety Consistent with U.S. FDA-Approved LabelOverall safety observations in this real-world study were consistent with the U.S. FDA-approved label.ARIA (amyloid-related imaging abnormalities)* was observed in 12.3% of patients overall; ARIA-E was observed in 6.3% and ARIA-H in 7.9% and isolated ARIA-H in 6.0%. Most ARIA cases were asymptomatic and mild in radiographic severity.No new ARIA-E events, macrohemorrhages or intracerebral hemorrhages greater than 1 cm were reported during once-every-four-weeks IV maintenance therapy.  APOE e4 status safety observations were consistent with the overall cohort and the U.S. FDA-approved label.ARIA-E was observed in 5.3% of APOE e4 noncarriers, 6.1% of APOE e4 heterozygotes and 10.3% of APOE e4 homozygotes.ARIA-H was observed in 12.1%, 4.8% and 12.1%, respectively.In APOE e4 homozygotes, no severe ARIA was reported, and all graded ARIA cases were mild to moderate in radiographic severity.Antithrombotic therapy, including anticoagulants or antiplatelet medications, was used by 106 patients, representing 24.5% of the study population.Of these, 11 patients were receiving an anticoagulant, either alone or with an antiplatelet medication, and 95 patients were receiving antiplatelet therapy only.Among patients receiving antithrombotic therapy, the incidence of ARIA was not meaningfully different from that observed in patients not receiving antithrombotic therapy.* ARIA refers to amyloid-related imaging abnormalities that can be observed with anti-amyloid beta antibody treatment and includes ARIA-E, which involves edema/effusion, and ARIA-H, which involves hemosiderin deposition, including cerebral microhemorrhage, cerebral macrohemorrhage and superficial siderosis, as observed on brain magnetic resonance imaging (MRI).Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.MEDIA CONTACTS 
Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department+44 (0)7760 619251Emea-comms@eisai.net Eisai Inc. (U.S.)Julie Edelman+1-862-213-5915Julie_Edelman@eisai.com Biogen Inc.Madeleine Shin +1-781-464-3260public.affairs@biogen.com 

INVESTOR CONTACTS
 Eisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122 Biogen Inc.Tim Power+1-781-464-2442IR@biogen.comNotes to EditorsAbout lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved LEQEMBI IQLIK, the subcutaneous autoinjector formulation of lecanemab, for use as maintenance treatment in August 2025 and as initiation treatment on July 13, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.About Protofibrils
Protofibrils are thought to be the most toxic Aß species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aß plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.2Limitations of Real-World Studies
Retrospective real-world studies can be valuable in providing additional information to complement clinical trial data; however, there are potential limitations to consider, including: potential for biases, data completeness and consistency, lack of a control group, interpretation of data due to lack of placebo-controlled arms, and confounding variables, and data inconsistency. Data inconsistency may be mitigated by providing site access to standardized electronic case-report forms.About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including  lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.ReferencesAmin L, Harris DA. Aß receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-zOno K, Tsuji M. Protofibrils of Amyloid-ß are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.  View original content to download multimedia:https://www.prnewswire.com/news-releases/leqembi-real-world-leader-study-presented-at-aaic-2026-finds-over-75-of-early-alzheimers-patients-enrolled-in-the-study-remained-stable-and-nearly-7-improved-over-an-average-of-17-months-of-treatment-302825236.htmlSOURCE Eisai Inc. Original: LEQEMBI® Real-World LEADER Study Presented at AAIC® 2026 Finds Over 75% of Early Alzheimer's Patients Enrolled in the Study Remained Stable and Nearly 7% Improved Over an Average of 17 Months of Treatment

Biogen Shares Rise After Positive Phase 2 Alzheimer’s Trial Results (BIIB)July 14, 2026 9:48 AM
IH Market News Biogen Inc. (NASDAQ:BIIB) traded higher after releasing encouraging Phase 2 data for its experimental Alzheimer’s treatment, diranersen, with results showing meaningful reductions in tau pathology alongside improvements across several measures of cognitive decline. The findings, presented at the Alzheimer’s Association International Conference, support the company’s decision to advance the therapy into Phase 3 clinical development. Study Shows Encouraging Cognitive Benefits The Phase 2 CELIA trial demonstrated clinical benefits across all dose levels after 18 months of treatment. The 60 mg dose delivered the strongest outcomes, slowing cognitive decline by 42% on the ADAS-Cog13 assessment and by 50% on the Mini-Mental State Examination (MMSE). The treatment also reduced disease progression by 26% on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) scale. Tau Biomarkers Decline Across All Doses According to Biogen, diranersen is the first tau-targeting therapy to demonstrate reductions in both cerebrospinal fluid total tau and brain tau pathology in a Phase 2 Alzheimer’s study. The treatment reduced total tau levels in cerebrospinal fluid by an average of 50% to 65%, while PET imaging also showed lower levels of tau accumulation in the brain across every dose evaluated. Diranersen is an antisense oligonucleotide designed to target MAPT messenger RNA, reducing production of all forms of the tau protein associated with Alzheimer’s disease. Phase 3 Programme Planned Based on the latest findings, Biogen confirmed it intends to move diranersen into Phase 3 clinical trials. The CELIA study enrolled 416 patients with early-stage Alzheimer’s disease, who received one of three intrathecal dose levels over an 18-month treatment period. Although the study did not achieve its primary endpoint of demonstrating a dose-response effect on the CDR-SB scale at 18 months, the broader clinical and biomarker results supported continued development. Safety Profile Remains Favourable Biogen said diranersen was generally well tolerated throughout the study. Most adverse events were classified as mild or moderate, with the most frequently reported events including procedural pain, post-lumbar puncture syndrome and episodes of confusional state. More than 90% of participants who completed the placebo-controlled portion of the study chose to continue into the ongoing extension trial. FDA Fast Track Status Supports Development The U.S. Food and Drug Administration granted Fast Track designation to diranersen in 2025 for the treatment of Alzheimer’s disease, potentially helping to accelerate the programme’s regulatory pathway as development progresses. Biogen stock priceThe post Biogen Shares Rise After Positive Phase 2 Alzheimer’s Trial Results (BIIB) appeared first on US Editors. Original: Biogen Shares Rise After Positive Phase 2 Alzheimer’s Trial Results (BIIB)

FDA Approves LEQEMBI IQLIK® (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer's DiseaseJuly 13, 2026 5:36 PM
PR Newswire (US) LEQEMBI IQLIK is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance (approved in the U.S.)U.S. launch of LEQEMBI IQLIK as an initiation dose planned for late August 2026TOKYO and CAMBRIDGE, Mass., July 13, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) as an initiation dose for the treatment of early Alzheimer's disease. Experience the full interactive Multichannel News Release here: https://www.multivu.com/Eisai/9406151-en-fda-approves-leqembi-for-early-alzheimers-diseaseLEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as subcutaneous (SC) injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration.LEQEMBI is indicated in the United States for adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. MCI due to AD is the earliest symptomatic stage of Alzheimer's disease and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words.Clinical Data Supporting FDA Approval of Subcutaneous Initiation DosingThe FDA approval of LEQEMBI IQLIK as an initiation dose is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and a range of dosing regimens. Sub-studies within the Phase 3 Clarity AD long-term extension (LTE), following the 18-month core study in individuals with early Alzheimer's disease, showed:Once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, supporting similar clinical (efficacy) and biomarker (amyloid removal) benefits.The rate of exposure-related adverse events such as ARIA-E with SC administration is expected to be comparable with IV administration. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for LEQEMBI compared to placebo.The overall safety profile of SC administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed."The approval of LEQEMBI IQLIK for initiation dosing marks a new era of Alzheimer's treatments," said Howard Fillit, MD, Co-Founder and Chief Science Officer Emeritus of the Alzheimer's Drug Discovery Foundation (ADDF). "For the first time, patients and their care partners have meaningful choice in how anti-amyloid treatment is delivered. As treatment approaches continue to expand, innovations in drug delivery will play a critical role in improving access to therapies, supporting the investigation of potential combination treatments, and advancing a precision medicine approach to Alzheimer's care."Expanding Treatment Flexibility Across the Alzheimer's Disease Care PathwayThe approval of LEQEMBI IQLIK as a subcutaneous initiation dose provides patients and care partners with the only at-home administration option throughout the Alzheimer's disease treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may:Reduce the burden of clinic visits currently associated with anti-amyloid therapy for patients and care partnersReduce reliance on infusion and associated healthcare resourcesDecrease treatment preparation and administration time, and nursing monitoring requirementsPreserve infusion capacity for patients who prefer or require intravenous therapyInsights from an autoinjector acceptability study indicated that 94% of patients with early Alzheimer's disease and their care partners found the LEQEMBI IQLIK device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting.*Support for Patients
The LEQEMBI CompanionTM program offers help with understanding insurance coverage and potential out-of-pocket costs, and identifying financial support programs, including the LEQEMBI Copay Assistance Program for eligible patients.To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria.LEQEMBI IQLIK for initiation dosing is expected to be available in late August 2026 in the U.S. Patients will receive LEQEMBI IQLIK from a specialty pharmacy.Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.*Based on in-person interviews of 50 patients with early AD and 50 care partners currently assisting people with early AD. Participants were given the opportunity to interact with a training autoinjector device (containing no needles or medication) and an injection pad, then asked to answer computer-based surveys about their experience, including "How difficult or easy was it to use the self-injection device?"INDICATION 
LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.IMPORTANT SAFETY INFORMATIONWARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)•         Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.o    Apolipoprotein E e4 (ApoE e4) Homozygotes: Patients who are ApoE e4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA.•         Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.WARNINGS AND PRECAUTIONSAMYLOID-RELATED IMAGING ABNORMALITIES
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.Incidence of ARIA 
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.Risk Factors of ARIA and ICH
ApoE e4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE e4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE e4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE e4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE e4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers.Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE e4 allele is also associated with CAA.The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE e4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE e4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.INFUSION-RELATED REACTIONS (IRRs)
IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.ADVERSE REACTIONSThe most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)The safety profile of subcutaneous LEQEMBI was similar to intravenous infusion. Subcutaneous dosing was associated with mostly localized (erythema, induration, swelling, heat, pain, pruritus, rash, ecchymosis, nodule, and hematoma) and less frequent systemic (headache, chills, fever, and fatigue) injection-related reactions, majority at first dose when initiating therapy. Localized reactions that were recurrent and/or delayed were observed. Severe localized reactions and cases leading to dose discontinuation or interruption occurred.LEQEMBI (lecanemab-irmb) is available:Intravenous infusion: 100 mg/mLSubcutaneous injection: 200 mg/mLPlease see full Prescribing Information for LEQEMBI, including Boxed WARNING.Click here to access the LEQEMBI digital library with assets available for download.MEDIA CONTACTS
Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd. EMEA Communications Department+44 (0) 7760 619251Emea-comms@eisai.netEisai Inc. (U.S.)Libby Holman+1-201-753-1945Libby_Holman@Eisai.com Biogen Inc.Madeleine Shin +1-781-464-3260public.affairs@biogen.com
INVESTOR CONTACTS

Eisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Tim Power+ 1-781-464-2442IR@biogen.comNotes to EditorsAbout lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's global placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Clarity AD evaluated lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897). 95% of patients who completed the core study (18 months) chose to continue in the long-term extension study (LTE), with 478 patients still receiving treatment for four years. In the Clarity AD core clinical study, data showed LEQEMBI IV significantly slowed disease progression at 18 months  (27% vs placebo), and the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale.To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person's ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.LEQEMBI also rapidly reduced plaque as early as three months (-59.1 CL difference vs placebo in amyloid level at 18 months; P

LEQEMBI® Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer's Disease Presented at the Alzheimer's Association International Conference® (AAIC®) 2026July 12, 2026 11:15 AM
PR Newswire (US) New clinical and real-world data support a subcutaneous treatment pathway from initiation through maintenance treatment, offering dosing convenience for patients and care partnersTOKYO and CAMBRIDGE, Mass., July 12, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that new data presented at the Alzheimer's Association International Conference® (AAIC®) 2026 in London support that the LEQEMBI® (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration for people with early Alzheimer's disease (AD). The data was featured during the "Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations" Developing Topics Session #1-32-FRS-C. AD is a chronic, progressive disease that requires ongoing treatment. LEQEMBI is an early AD treatment that targets the underlying pathology of the disease, helping to slow cognitive decline and loss of daily functioning. The lecanemab subcutaneous auto-injector (SC-AI) was developed to provide a more convenient alternative to intravenous (IV) dosing from the initiation of treatment.Key Findings
This session presented data from the lecanemab SC-AI development program in early Alzheimer's disease, including pharmacokinetic (PK), pharmacodynamic (PD), efficacy, safety and real-world patient and care partner experience findings. Results showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved intravenous (IV) initiation regimen (10 mg/kg every two weeks), supporting the expectation of similar clinical efficacy and safety, independent of the route of administration.If approved by the United States Food and Drug Administration (FDA), subcutaneous dosing for initiation may offer a convenient at-home alternative to IV infusion which could support access and delivery of care across healthcare settings.Data ShowedBioequivalence Achieved: Once-weekly 500 mg SC-AI demonstrated bioequivalence to the IV initiation regimen (10 mg/kg every two weeks), with an exposure ratio of 104% (90% confidence interval [CI]: 99.1%–109%). Exposure remained consistent across body weight quartiles, demonstrating a stable pharmacokinetic profile in a broad patient population.Efficacy Driven by Exposure, Not Route of Administration: Amyloid removal measured by amyloid PET, clinical efficacy measured by CDR-SB, and the incidence of ARIA-E were driven by lecanemab exposure rather than route of administration. The 500 mg SC-AI initiation regimen achieved exposure comparable to the IV initiation regimen, supporting the expectation of a comparable efficacy and safety profile despite the different route of administration.Consistent Results Across Patient Populations: The 500 mg SC-AI initiation regimen demonstrated consistent exposure, amyloid clearance as measured by amyloid PET, clinical efficacy and safety across body weight groups. In addition, amyloid clearance and clinical outcomes were not meaningfully affected by body weight, supporting the appropriateness of a fixed-dose regimen.Flexible switching between IV and SC administration: Patients may also switch from IV to SC administration, or vice versa, and if a dose is missed patients can take it the next day or up to day six providing greater convenience and flexibility in LEQEMBI administration.Safety Profile Aligned of SC LEQEMBIOverall safety profile of SC-AI was generally consistent with that observed for the IV formulation.Incidence of ARIA-E with the 500 mg SC-AI initiation regimen was predicted to be similar to that observed with the IV initiation regimen.Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed.The incidence of anti-drug antibodies (ADA) was low, at 1.4% in the 500 mg SC-AI group. No neutralizing antibodies were observed, confirming that the low immunogenicity profile was maintained with the SC-AI formulation.Clinical Trial Perspectives and Real-World Evidence: Sustained Clinical Benefit with SC-AIData from two U.S. Alzheimer's treatment centers (Alzheimer's Research and Treatment Center, and First Choice Neurology and Visionary Investigators Network) provide early insight into clinical trial and real-world use of subcutaneous LEQEMBI:At Alzheimer's Research and Treatment Center, 28 patients receiving SC administration demonstrated slower cognitive decline as measured by CDR-SB over 36 months relative to a matched Alzheimer's Disease Neuroimaging Initiative (ADNI) natural history cohort. The cohort included 25 patients newly initiated on SC administration and 3 patients who transitioned from IV administration. In a separate case series from First Choice Neurology and Visionary Investigators Network, 10 of 11 evaluable patients (91%) showed improvement or remained stable on MMSE compared with baseline before maintenance therapy. At this center, patients who had received maintenance therapy with SC administration for at least 6 months were included in the analysis.Patient and care partner surveys in these two sites demonstrated high satisfaction with subcutaneous LEQEMBI administration, with satisfaction rates ranging from 75% to 97%, convenience ratings from 83% to 97%, and willingness to recommend treatment ranging from 92% to 100%.Results presented in this session further reinforce the importance of early and continuous treatment, highlighting how LEQEMBI SC initiation and maintenance administration provides greater optionality for long-term disease management.Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.MEDIA CONTACTS
Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120 Eisai Europe, Ltd.  EMEA Communications Department +44 (0) 797 487 9419 Emea-comms@eisai.net  Eisai Inc. (U.S.)Libby Holman+1201-753-1945Libby_Holman@eisai.com  Biogen Inc.Madeleine Shin +1-781-464-3260public.affairs@biogen.com INVESTOR CONTACTS 
Eisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Tim Power+ 1-781-464-2442IR@biogen.comNotes to EditorsAbout lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai, and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.About Protofibrils
Protofibrils are thought to be the most toxic Aß species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aß plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.2About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including  lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.ReferencesAmin L, Harris DA. Aß receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021; 12:3451. doi: 10.1038/s41467-021-23507-z.Ono K, Tsuji M. Protofibrils of Amyloid-ß are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.  View original content to download multimedia:https://www.prnewswire.com/news-releases/leqembi-subcutaneous-autoinjector-clinical-data-supports-similar-efficacy-and-safety-to-iv-formulation-in-early-alzheimers-disease-presented-at-the-alzheimers-association-international-conference-aaic-2026-302823332.htmlSOURCE Eisai Inc. Original: LEQEMBI® Subcutaneous Autoinjector Clinical Data Supports Similar Efficacy and Safety to IV Formulation in Early Alzheimer's Disease Presented at the Alzheimer's Association International Conference® (AAIC®) 2026

Biogen Shares Surge After Positive Mid-Stage Alzheimer’s Trial ResultsMay 14, 2026 10:08 AM
IH Market News Biogen (NASDAQ:BIIB) shares jumped 10% on Thursday after the company released encouraging Phase 2 data for diranersen, its experimental Alzheimer’s treatment targeting tau protein accumulation.The results came from the company’s CELIA study, which evaluated the therapy in patients with early-stage Alzheimer’s disease. Trial Shows Reductions in Tau Pathology Biogen said diranersen produced significant reductions in tau pathology across all dose levels tested.The findings were consistent with data previously observed in an earlier Phase 1b trial.The treatment reduced both cerebrospinal fluid tau levels and tau pathology measured through positron emission tomography imaging, with reductions maintained throughout the dosing period. Cognitive Decline Slowed Across Tested Doses Pre-specified analyses of cognitive endpoints showed slowing of clinical decline across all studied doses.According to the company, the most notable benefit was observed with the lowest dose of 60 mg administered every 24 weeks.However, the study did not achieve its primary endpoint, which evaluated dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes at Week 76. Study Included More Than 400 Participants The 18-month CELIA study enrolled 416 participants diagnosed with either mild cognitive impairment related to Alzheimer’s disease or mild Alzheimer’s dementia.Participants had not previously received anti-amyloid therapies.Researchers evaluated three dosing regimens during the study: 60 mg every 24 weeks 115 mg every 24 weeks 115 mg every 12 weeks Safety Profile Largely Consistent With Earlier Study Biogen said the safety and tolerability profile of diranersen was generally in line with results from the earlier Phase 1b study.The frequency of adverse events was similar across dose groups, although the highest-dose group experienced a greater number of serious adverse events. Biogen Plans Registrational Development The company said it intends to move diranersen into registrational development and plans to discuss the next regulatory steps with health authorities.The U.S. Food and Drug Administration granted Fast Track designation to diranersen for Alzheimer’s disease treatment in 2025.Diranersen is an antisense oligonucleotide designed to reduce production of tau protein.Unlike therapies targeting only extracellular tau, diranersen aims to reduce both extracellular and intracellular tau.Biogen said additional data from the study will be presented at the Alzheimer’s Association International Conference 2026. Analysts View Advancement Decision as Positive Signal Paul Matteis of Stifel said the company’s decision to continue development despite missing the primary endpoint reflects strong internal confidence in the program.“We would be surprised if they were advancing this on efficacy data that looks worse than the amyloid drugs,” Matteis wrote in a note to clients. “The ’bar’ for advancing this shouldn’t necessarily be statistical significance, because there is still a lot we don’t know around the right population to test the tau thesis.”Matteis also noted that under chief executive Chris Viehbacher, Biogen has aggressively reduced exposure to higher-risk research projects, suggesting management likely sees meaningful potential in the therapy. Dose Response Raises Questions for Investors One of the key discussion points for investors is the study’s non-linear dose response pattern.Typically, higher doses are expected to deliver stronger efficacy, but the CELIA study showed the greatest cognitive benefit at the lowest 60 mg dose rather than at the higher 115 mg levels.Matteis described the issue as an “open question,” suggesting it is theoretically possible that reducing tau levels too aggressively could create offsetting negative effects, although he stressed that conclusion remains speculative until more detailed data becomes available.Biogen stock price Original: Biogen Shares Surge After Positive Mid-Stage Alzheimer’s Trial Results

Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's DiseaseMay 8, 2026 2:30 AM
PR Newswire (US) TOKYO and CAMBRIDGE, Mass., May 8, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026.   As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose.Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025.LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease.Eisai and Biogen look forward to ongoing discussions with the FDA as the review progresses and are committed to bringing this important advancement to patients and care partners as quickly as possible to provide greater flexibility and choice in how anti-amyloid treatment is delivered.INDICATION
LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.IMPORTANT SAFETY INFORMATIONWARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.Apolipoprotein E e4 (ApoE e4) Homozygotes: Patients who are ApoE e4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA.Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.CONTRAINDICATION
Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.WARNINGS AND PRECAUTIONS
Amyloid-Related Imaging Abnormalities
Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.Incidence of ARIA
Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.Incidence of ICH
ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.Risk Factors of ARIA and ICH
ApoE e4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE e4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE e4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE e4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE e4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers.Radiographic Findings of CAA
Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE e4 allele is also associated with CAA.The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.Concomitant Antithrombotic or Thrombolytic Medication
In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.Radiographic Severity With LEQEMBI
Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE e4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE e4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).Monitoring and Dose Management Guidelines
Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.Infusion-Related Reactions (IRRs)
IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.ADVERSE REACTIONSThe most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)LEQEMBI (lecanemab-irmb) is available:Intravenous infusion: 100 mg/mLSubcutaneous injection: 200 mg/mLPlease see full Prescribing Information for LEQEMBI, including Boxed WARNING.MEDIA CONTACTS
Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Inc. (U.S.)Julie Edelman+1-862-213-5915Julie_Edelman@eisai.comBiogen Inc.Madeleine Shin +1-781-464-3260public.affairs@biogen.com

INVESTOR CONTACTS
Eisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Tim Power+ 1-781-464-2442IR@biogen.comNotes to EditorsAbout lecanemab (generic name, brand name: LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai, and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.About Protofibrils
Protofibrils are thought to be the most toxic Aß species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms. The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aß plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including  lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.  View original content to download multimedia:https://www.prnewswire.com/news-releases/update-on-fda-priority-review-of-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-as-a-starting-dose-for-early-alzheimers-disease-302766585.htmlSOURCE Eisai Co., Ltd. Original: Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's Disease

Bright Horizons Family Solutions and Remitly Global Set to Join S&P SmallCap 600May 7, 2026 6:01 PM
PR Newswire (US) NEW YORK, May 7, 2026 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P SmallCap 600 effective prior to the opening of trading on Thursday, May 14: Bright Horizons Family Solutions Inc. (NYSE: BFAM) will replace Tri Pointe Homes Inc. (NYSE: TPH). Sumitomo Forestry Group (TSE: 1911) is acquiring Tri Pointe Homes in a deal expected to close soon, pending final closing conditions.Remitly Global Inc. (NASD: RELY) will replace Apellis Pharmaceuticals Inc. (NASD: APLS). S&P 500 constituent Biogen Inc. (NASD: BIIB) is acquiring Apellis Pharmaceuticals in a deal expected to close soon, pending final closing conditions.Following is a summary of the changes that will take place prior to the open of trading on the effective date:Effective DateIndex Name       ActionCompany NameTickerGICS SectorMay 14, 2026S&P SmallCap 600AdditionBright Horizons Family SolutionsBFAMConsumer DiscretionaryMay 14, 2026S&P SmallCap 600DeletionTri Pointe HomesTPHConsumer DiscretionaryMay 14, 2026S&P SmallCap 600AdditionRemitly GlobalRELYFinancialsMay 14, 2026S&P SmallCap 600DeletionApellis PharmaceuticalsAPLSHealth CareABOUT S&P DOW JONES INDICESS&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.S&P Dow Jones Indices is a division of S&P Global (NYSE: SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spglobal.com/spdji/en/.FOR MORE INFORMATION:S&P Dow Jones Indices
index_services@spglobal.comMedia Inquiries
spdji.comms@spglobal.com View original content:https://www.prnewswire.com/news-releases/bright-horizons-family-solutions-and-remitly-global-set-to-join-sp-smallcap-600-302766326.htmlSOURCE S&P Dow Jones Indices Original: Bright Horizons Family Solutions and Remitly Global Set to Join S&P SmallCap 600

Results from Real-World, Long-Term Treatment Persistence with LEQEMBI® (lecanemab-irmb) in the United States Presented at AD/PD™ 2026March 20, 2026 12:05 PM
PR Newswire (US)

Real-World LEQEMBI Data Shows Patients Choose to Stay on Long-Term Treatment TOKYO and CAMBRIDGE, Mass., March 20, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that new real-world findings from an analysis of long-term treatment persistence and baseline characteristics among people receiving intravenous (IV) lecanemab (generic name, brand name LEQEMBI®), an anti-amyloid-ß (Aß) protofibril antibody, showed that most patients continue with ongoing lecanemab therapy after the initial 18 months of treatment. The analysis was presented at the 20th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online.







In real-world clinical practice, patients with chronic diseases who stay on their treatments longer tend to experience better clinical outcomes and higher satisfaction.1,2 Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD study chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE of the Clarity AD study, patients continue to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer's disease (Alzheimer's Disease Neuroimaging Initiative: ADNI*).Long-Term Persistence and Patient Characteristics for Lecanemab in Real-World Use in the United States (Presentation: March 20, 17:05 CET)
This analysis is the first time real-world lecanemab data on treatment persistence beyond 18 months has been reported.This study was a retrospective observational analysis using the PurpleLab® CLEAR Claims database, a comprehensive dataset based on medical insurance claims across the United States and was conducted to evaluate the long-term treatment persistence of lecanemab in real-world clinical practice.¦ Patient background and dosing
The analysis population consisted of 10,763 individuals who met the requirement for continuous healthcare encounters, out of the 13,388 individuals recorded in the database who received at least one IV treatment with lecanemab between January 6, 2023 and November 30, 2025. At baseline, the mean age was 73.8 years and 56.5% were female. The most common comorbidities were dyslipidemia (42.2%) and hypertension (36.9%). The mean follow-up duration was 350.9 days. The average number of administrations was 1.7 per month, and the mean dosing interval was 16.4 days (median 14 days), which was generally consistent with the recommended every two weeks dosing.¦ Long-Term persistence results
The time-dependent proportion of patients who remained on lecanemab treatment was evaluated using the Kaplan–Meier method in a subgroup of 371 patients who initiated treatment in 2023 and had 20 months of continuous follow-up, thereby enabling assessment of long-term treatment persistence beyond 18 months. As a result, 78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. Of the 78.4% of patients who remained on lecanemab at 18 months, the majority of them continued treatment during the maintenance period beyond 18 months, confirming a high rate of treatment persistence with lecanemab in real-world clinical practice. The patient characteristics and dosing patterns observed in this claims-based analysis were generally similar to those reported in the Clarity AD study. Furthermore, the relatively high treatment adherence observed among individuals suggests that potential delays due to MRI monitoring requirements, adverse events, and other factors did not substantially affect lecanemab dosing.Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.* ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.[Notes to Editors] About lecanemab (generic name, brand name: LEQEMBI)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 10 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A Supplemental Biologics License Application (sBLA) for initiation treatment was accepted in January 2026. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, Lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.In the global Phase 3 placebo-controlled, double-blind, parallel-group, randomized Clarity AD core study, the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person's ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.3,4Over three years of treatment, including both the core study and the OLE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER** cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four years mark.Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.** BioFINDER subjects are similar to Study 301 and ADNI subjects, except all BioFINDER subjects are in the MCI stage and no mild AD subjects are included, and their baseline CDR-SB is lower. BioFINDER is a large-scale, long-term prospective study led by Lund University in Sweden, aiming to establish early. diagnosis and elucidate pathophysiology of neurodegenerative diseases. In addition to AD, the study also focuses on conditions including Parkinson's Disease. Individuals participating in the study undergo regular clinical assessments, cognitive function tests, brain imaging (MRI, Aß PET, Tau PET), and collection of biomarkers from blood and cerebrospinal fluid (CSF).About Protofibrils
Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of soluble Aß, having a primary role in the cognitive decline associated with this progressive, debilitating condition.5 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aß plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.6About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (marketed as LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI); the potential to expand options and reduce healthcare resources by treating Alzheimer's disease at home; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "outlook," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would" or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.ReferencesGuerci B et al. Lack of treatment persistence and treatment nonadherence as barriers to glycaemic control in patients with type 2 diabetes. Diabetes Therapy, 2019; 10(2), 437-449.Menditto E et al. Persistence as a robust indicator of medication adherence-related quality and performance. International journal of environmental research and public health, 2021; 18(9), 4872.Cohen S., et al. J Prev Alzheimers Dis.2022;9(3):507-522.Morris JC. Neurology. 1993;43(11):2412-4.Amin L, Harris DA. Aß receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021; 12:3451. doi:10.1038/s41467-021-23507-z.Ono K, Tsuji M. Protofibrils of Amyloid-ß are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.



View original content to download multimedia:https://www.prnewswire.com/news-releases/results-from-real-world-long-term-treatment-persistence-with-leqembi-lecanemab-irmb-in-the-united-states-presented-at-adpd-2026-302719271.htmlSOURCE Eisai Inc.

Original: Results from Real-World, Long-Term Treatment Persistence with LEQEMBI® (lecanemab-irmb) in the United States Presented at AD/PD™ 2026

Biogen shares Phase 1b findings for salanersen in spinal muscular atrophyMarch 11, 2026 11:09 AM
IH Market News
Biogen Inc. (NASDAQ:BIIB) unveiled results from a Phase 1b clinical study evaluating salanersen, an experimental antisense oligonucleotide therapy for spinal muscular atrophy (SMA), during the 2026 Muscular Dystrophy Association Clinical & Scientific Conference on Wednesday.The trial involved 24 children aged between six months and 12 years who continued to show suboptimal clinical outcomes after receiving gene therapy. Each participant received at least two annual doses of salanersen—either 40 mg or 80 mg. According to a press release, all participants were followed for at least one year.Results showed that patients treated with salanersen experienced a 75% drop in neurofilament light chain levels after six months, with the reduction sustained throughout the follow-up period. All 24 participants demonstrated improvements from baseline on at least one clinical endpoint. Twelve patients achieved at least one additional World Health Organization motor milestone, while every participant maintained the milestones they had already reached.The treatment was generally well tolerated at both dosage levels. Among participants receiving the 40 mg dose, the most frequently reported adverse events were upper respiratory tract infections and vomiting. In the 80 mg group, the most common events were fever and upper respiratory infections. Most side effects were classified as mild to moderate.Biogen also outlined the design of its upcoming Phase 3 clinical programme, which will evaluate an 80 mg dose of salanersen across three international studies. The STELLAR-1 study will focus on treatment-naïve infants younger than six weeks. STELLAR-2, a randomized, double-blind, sham-controlled trial, will examine salanersen administered six months after gene therapy in infants. The SOLAR study will evaluate the therapy in adolescents and adults aged 15 to 60 who are either treatment-naïve or previously treated with risdiplam.Screening for STELLAR-1 has already begun. The SOLAR study is expected to launch in the second quarter of 2026, while STELLAR-2 is planned to start in the third quarter of the year.Biogen obtained global development and commercialization rights for salanersen through a licensing agreement with Ionis Pharmaceuticals.Biogen has also drawn attention from several analysts recently. Barclays initiated coverage with an Equalweight rating and a price target of $185. Goldman Sachs maintained a Buy rating and set a $231 price target, citing strong sales of the Alzheimer’s treatment Leqembi. BMO Capital Markets raised its target price to $196, pointing to potential growth for Biogen’s Spinraza therapy. Meanwhile, TD Cowen increased its price target to $215 after the company reported fourth-quarter results that exceeded revenue and earnings expectations.Biogen stock price

Original: Biogen shares Phase 1b findings for salanersen in spinal muscular atrophy

Biogen stock edges higher after Q4 beat and upbeat 2026 earnings guidanceFebruary 6, 2026 9:45 AM
IH Market News
Biogen Inc. (NASDAQ:BIIB) delivered stronger-than-expected results for the fourth quarter of 2025 and paired them with a confident profit outlook for 2026, lifting its shares modestly higher following the announcement.The biotech group reported adjusted earnings of $1.99 per share, comfortably ahead of analyst expectations of $1.61. Revenue totaled $2.28 billion, topping the consensus forecast of $2.21 billion, although this marked a 7% decline from the prior year. Biogen shares rose around 1.4% after the results were released.Performance from newer growth therapies remained a bright spot. Sales from growth products rose 6% year over year in the quarter. Global in-market sales of LEQEMBI reached about $134 million, up 54% from a year earlier, while ZURZUVAE generated roughly $66 million in revenue, reflecting strong uptake. SKYCLARYS also continued to gain traction, with the number of patients on therapy increasing by around 30% during 2025.“Our 2025 performance reflected continued focus on strong execution and financial discipline, driven by our revenue of nearly $1 billion from LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY, progression of our pipeline, and resilience of our MS franchise,” said Christopher A. Viehbacher, President and Chief Executive Officer.Looking ahead, Biogen forecast adjusted earnings per share of $15.25 to $16.25 for fiscal 2026, above the Street consensus of $14.92. The company cautioned, however, that total revenue is expected to fall by a mid-single-digit percentage versus 2025, as continued declines in multiple sclerosis product sales—excluding VUMERITY—are only partly offset by growth from newer therapies.Biogen stock price

Original: Biogen stock edges higher after Q4 beat and upbeat 2026 earnings guidance

Amazon’s capex surge, Stellantis reset, Bitcoin slide – what’s driving markets: Dow Jones, S&P, Nasdaq, Wall Street FuturesFebruary 6, 2026 5:30 AM
IH Market News
U.S. equity futures edged lower on Friday as weakness in technology stocks persisted. Online retail giant Amazon (NASDAQ:AMZN) unveiled a sharp increase in capital spending, while carmaker Stellantis (NYSE:STLA) flagged a major strategic rethink away from electric vehicles. Bitcoin (COIN:BTCUSD) continued to slide, and oil markets remained focused on the outcome of talks between the United States and Iran.



Amazon plans sharp rise in capital expenditure



Amazon (NASDAQ:AMZN) was among the last major tech groups to report quarterly results after Thursday’s Wall Street close and followed peers in outlining a significant ramp-up in spending on artificial intelligence infrastructure.Chief executive Andy Jassy said Amazon intends to invest $200 billion in expanding its AI capabilities in 2026, implying a more than 50% jump in capital expenditure this year. The scale of the spending increase unsettled investors, pushing the stock sharply lower in after-hours trading.The announcement reinforced expectations that Big Tech is far from easing back on AI investment. The four largest hyperscalers—Amazon, Microsoft, Google and Meta—are now forecast to spend more than $630 billion collectively this year.On the numbers, Amazon posted fourth-quarter 2025 earnings of $1.95 per share on revenue of $213.39 billion, up 13.6% year on year, narrowly missing profit forecasts. Amazon Web Services delivered revenue of $35.6 billion in the December quarter, with sales growth of 24%, its strongest pace in 13 quarters.While AWS represents only around 15–20% of group revenue, it generates more than 60% of Amazon’s operating profit.
“Amazon delivered a slightly mixed picture with strong overall revenue growth and a standout boost from the cloud unit’s much anticipated reacceleration picking up greater speed,” Emarketer principal analyst Sky Canaves said.



U.S. futures slip as Wall Street eyes weekly losses



U.S. stock futures were lower early Friday, extending recent declines as Amazon’s selloff weighed on the broader technology sector. At 03:35 ET, S&P 500 futures were down 0.2%, Nasdaq 100 futures slipped 0.4%, and Dow futures eased 0.1%.Wall Street closed sharply lower on Thursday, with the Nasdaq Composite dropping 1.6%, the S&P 500 falling 1.2% and the Dow Jones Industrial Average shedding more than 500 points. The Nasdaq is on track for its worst weekly performance since early April, down around 4%, while the S&P 500 has lost roughly 2%. The Dow is broadly flat for the week.More corporate results are due later Friday, including updates from Under Armour (NYSE:UAA), Biogen (NASDAQ:BIIB), AutoNation (NYSE:AN) and Philip Morris (NYSE:PM). The U.S. jobs report, originally scheduled for Friday, has been pushed to next week following the resolution of the federal government shutdown.Separately, data from Challenger, Gray & Christmas showed announced layoffs by U.S. employers surged in January to the highest level for the month in 17 years.



Stellantis books major charge in “strategic shift”



Stellantis (NYSE:STLA) said it would take a charge of around €22 billion ($26.5 billion) linked to a reassessment of its electric vehicle strategy, resulting in a preliminary loss of between €19 billion and €21 billion in the second half of 2025.The group said the majority of the write-downs relate to changes in its product roadmap, driven by sharply reduced assumptions for EV demand.
“The charges announced today largely reflect the cost of over-estimating the pace of the energy transition that distanced us from many car buyers’ real-world needs, means and desires,” said Stellantis CEO Antonio Filosa in a statement.The Franco-Italian automaker described the move as a “strategic shift” as it responds to high costs and softer-than-expected EV sales. Stellantis, along with other major European manufacturers such as Volkswagen, has also called for subsidies to support car production in the EU amid pressure from U.S. tariffs and rising competition from China.



Bitcoin heads for steep weekly decline



Bitcoin weakened further on Friday, leaving the world’s largest cryptocurrency on course for a heavy weekly loss as confidence in risk assets continued to fade. Bitcoin fell more than 9% to around $64,730, after earlier touching a 16-month low near $60,100.The digital asset was heading for a third consecutive weekly decline and was down more than 20% over the week. It has also lost over half its value from the record high reached in October and has erased all gains made since President Donald Trump’s election victory in late 2024.Bitcoin has been hit by a broader retreat from speculative assets, with selling pressure intensifying after Trump nominated Kevin Warsh as his preferred candidate for Federal Reserve chair. Warsh has previously opposed the Fed’s asset-purchase programs, and expectations of a leaner central bank balance sheet have weighed on crypto markets.Adding to the pressure, major corporate holder Strategy (NASDAQ:MSTR) reported a much wider fourth-quarter loss on Thursday, largely reflecting declines in the value of its Bitcoin holdings.



Oil prices up, but weekly losses loom ahead of talks



Oil prices rose on Friday but remained on track for their first weekly decline in nearly two months, as investors awaited the outcome of U.S.–Iran talks later in the day. Brent crude climbed 1.3% to $68.38 a barrel, while U.S. West Texas Intermediate gained 1.4% to $64.19.Despite the rebound, Brent was set to finish the week down 3.3% and WTI lower by around 1.8%, with U.S. and Iranian officials due to meet in Oman amid elevated tensions in the Middle East. Markets have been hoping that dialogue between Washington and Tehran could help ease tensions and reduce the risk of wider conflict, prompting traders to remove some geopolitical risk premium from oil prices this week.However, uncertainty remains after reports of disagreement over the scope of the talks, with Iran rejecting U.S. calls to include discussions on its missile program and saying negotiations would be limited to nuclear issues. Iran is a major oil producer and sits next to the Strait of Hormuz, one of the world’s most critical shipping routes for crude.Amazon stock priceStellantis stock priceStrategy stock price

Original: Amazon’s capex surge, Stellantis reset, Bitcoin slide – what’s driving markets: Dow Jones, S&P, Nasdaq, Wall Street Futures

🌿 Multiple Sclerosis: Plant Relief vs. Engineered Immunotherapy
Medical cannabis: Oils, sprays, and edibles are used to ease muscle spasms and nerve pain, marketed as natural symptom management.

Biotech/Pharma: Pharma giants invest in immunotherapies and biologics — highly engineered drugs that target immune cells at the molecular level.

The clash: Cannabis offers accessible, plant-based comfort, while biotech emphasizes cutting-edge science and expensive treatments. $BIIB $MSOS $MJ $TOKE

https://x.com/AnnaRMatson/status/1925611186935984247 $BIIB

BIIB, new 52 week low

BIIB new 52 week low

Biib must be out of AD bullets…or actually more like BB’s. With 3-4 20 billion dollar swap trading by HF’s the stock is at multiyear lows. It used to hit $200 and would spring up like clock work.

I hope the validation of our science upon MAA approval at AVXL puts a fork in this company making their pipeline overly insignificant.

BIIB still in bear mode

https://www.sciencetimes.com/articles/50071/20240508/anavex-life-sciences-alzheimers-treatment-brings-hope-to-millions.htm

BIIB still in bear mode

Oops…. Another HOD


$10

BIIB Took a little short AH when it's PDUFA decision was mixed
Shorted at 261.50
Closed out AH at 260.87
Not expecting more than a hamburger and fries. BIOGEN INC is huge company and hard to move its dial.

https://stockcharts.com/h-sc/ui?s=BIIB

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer's Disease

This board is about to light up!

Well Biib and Esaly look to be joined at the hip. And here I thought they were two profitable independent companies. Amazing how they have traded virtually identical as if this is their only ticket left to punch.

And why no run up? Is the gig finally up Mc? Maybe their MM “cried wolf” one too many times.

Who wants to be the lead Buffalo today?
Can you stampede the herd of bio thieves over the $30Billion dollar cliff for the fourth time? Maybe! But you are stealing from treatments and patients and all those who love them.. for nothing..
The best aduscam will ever be is an adjuvant to anavex or cassava..

The BEST..

Don’t do it again .. even if you can..

Please

Funds swapping spit again, nothing new.

Imagine if fda had denied?
Pyrrhic Victory defined

Amen MC. Im surprised at only a 3.5% rise in pps. Wheres the 10-20 billion MC increase enthusiasm like 4 times before? Maybe they will have to PR it again in a week so the market “gets it”.

Ps not short Biogen..
Just long dementia

Investors can make a difference as to what our healthcare system becomes..

You and your decisions affect millions of lives..

Let Blarcamesine , succesful TLD ,
Be the rule of the day for our sick..

See if other drugs help people once their homeostasis is secured..maybe in smaller doses as an adjuvant ..

Anavex’s Blarcamesine works

If you will give a healthy 5 year old an experimental mRNA drug which creates toxic spike proteins in their system..by design! Nonetheless, why wouldn’t you give death sentenced dementia patients a dangerous possibly brain swelling drug that does almost nothing?

The system is broken

This will be the last chance to extricate your financial future from bioscam
And invest in one of these :
Anavex
Cassava
Annovis

Biovie

In that order of magnitude per solution and timing ..in my humble opinion

Or all four..

Will Biogen drop like a rock by or shoot up by 10 billion come Friday? FDA is in a pickle here. Is there an advisory panel this go around or is this who will weigh in come Friday?

What a scam! Older article but will take afew years to play out Im sure.

Biogen Accused of Baiting Patients With Illegal Drug Co-Pays
ByRobert Burnson
September 24, 2021, 9:57 PM EDT

Biogen Inc. was accused by a managed-care provider of illegally boosting sales of its pricey multiple sclerosis drugs by providing them free to patients on a temporary basis and then funneling money to them for co-payments so they can keep taking the medications.

The first part of the scheme involves “seeding” the drugs -- Tysabri, Avonex, and Tecfidera -- to multiple sclerosis sufferers who lacked medical insurance, according to the lawsuit filed Friday by Humana Inc.

After a few months, Biogen encourages the patients to sign up for government-funded healthcare and then funnels “illegal copayment assistance to those same patients under the guise of unrestricted charitable giving,” Humana said.

The money is funneled through a large specialty pharmacy and two medical charities who provide co-pay assistance, according to the suit.

“Given the high costs of the MS drugs here, copays can be thousands of dollars for any single patient,” Humana says in the suit.“But they are a tiny fraction of the total expense for the drugs. This means that if the manufacturer pays the copays itself, it can earn a major return from a minor investment.”

The drugs cost $50,000 to $80,000 a year, according to the suit.

Biogen didn’t respond after regular business hours to a request for comment.

RGEN is on a run while Biogen is stalled.. Both similar companies,

https://www.marketwatch.com/press-release/grabar-law-office-investigates-claims-on-behalf-of-shareholders-of-biogen-inc-biib-after-it-agrees-to-pay-900-million-for-improper-physician-payments-2022-11-30?siteid=bigcharts&dist=bigcharts&tesla=y

Unlike the patients heads, the share price “swelling” for Biogen always goes down. Another difference is Biogens Alzheimer’s amyloid platform never dies, just a few of their patients here and there in their trials.

Alzheimer’s is tough, didnt you know, just a little collateral damage, now hurry up and give me approval!

How does this dead dog bounce?
On swelled brains of course

One last dance?

Wouldnt touch bioscam
But agree seller salmoat out

Biogen (NASDAQ:BIIB) was upgraded by analysts at Wells Fargo & Company from an "equal weight" rating to an "overweight" rating. They now have a $265.00 price target on the stock, up previously from $235.00.This represents a 23.7% upside from the current price of $214.28

---- Biotechs are due for a run soon....jmo

Phase 4. How many must suffer to pave the linings? When anavex has safe and proved drug available now?
How hateful the crews that say they care about human beings suffering dementia..

You don’t give a shit

Can you imagine the poor bastards that listened to Corey Renauer of motley fool when he said sell Anavex and buy Biogen a few years back?
Can they sue anyone?

What a cruel and twisted effort that was