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BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.

–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–

BEDFORD, Mass. and CAMBRIDGE, Mass., Sept. 01, 2026 (GLOBE NEWSWIRE) -- 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. 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.

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.

Canada Pension Plan Investment Board purchased a new position in shares of Biogen Inc. (NASDAQ:BIIB – Free Report) during the second quarter, according to its most recent disclosure with the Securities & Exchange Commission. The institutional investor purchased 13,602 shares of the biotechnology company’s stock, valued at approximately $2,939,000.

Several other hedge funds and other institutional investors have also recently made changes to their positions in BIIB. Empowered Funds LLC raised its stake in Biogen by 64.9% in the first quarter. Empowered Funds LLC now owns 7,054 shares of the biotechnology company’s stock valued at $965,000 after buying an additional 2,777 shares during the last quarter. Focus Partners Wealth grew its stake in shares of Biogen by 172.2% during the first quarter. Focus Partners Wealth now owns 10,173 shares of the biotechnology company’s stock worth $1,392,000 after acquiring an additional 6,436 shares during the last quarter. Sivia Capital Partners LLC acquired a new position in shares of Biogen during the second quarter valued at about $216,000. Cerity Partners LLC increased its holdings in shares of Biogen by 15.3% during the second quarter. Cerity Partners LLC now owns 46,552 shares of the biotechnology company’s stock valued at $5,847,000 after acquiring an additional 6,184 shares in the last quarter. Finally, NewEdge Advisors LLC raised its position in shares of Biogen by 13.4% in the 2nd quarter. NewEdge Advisors LLC now owns 2,673 shares of the biotechnology company’s stock valued at $336,000 after purchasing an additional 316 shares during the last quarter. Hedge funds and other institutional investors own 87.93% of the company’s stock.

Biogen Stock Performance NASDAQ BIIB opened at $218.50 on Monday. Biogen Inc. has a 1 year low of $131.52 and a 1 year high of $222.85. The company has a debt-to-equity ratio of 0.39, a current ratio of 1.87 and a quick ratio of 1.26. The company has a market capitalization of $32.28 billion, a PE ratio of 38.67, a P/E/G ratio of 6.81 and a beta of 0.17. The company has a fifty day moving average of $207.81 and a 200 day moving average of $195.69.

Biogen (NASDAQ:BIIB – Get Free Report) last released its quarterly earnings data on Wednesday, July 29th. The biotechnology company reported $3.60 earnings per share for the quarter, beating analysts’ consensus estimates of $2.94 by $0.66. The business had revenue of $2.74 billion during the quarter, compared to analyst estimates of $2.46 billion. Biogen had a return on equity of 11.18% and a net margin of 8.32%.The company’s revenue was up 3.4% on a year-over-year basis. During the same quarter last year, the business posted $5.47 EPS. Biogen has set its FY 2026 guidance at 12.000-13.000 EPS. Research analysts forecast that Biogen Inc. will post 12.39 earnings per share for the current year. Wall Street Analysts Forecast Growth A number of research firms recently commented on BIIB. UBS Group lifted their target price on shares of Biogen from $225.00 to $240.00 and gave the stock a “buy” rating in a research note on Thursday, July 30th. Piper Sandler restated an “overweight” rating on shares of Biogen in a research note on Tuesday, July 14th. Weiss Ratings cut shares of Biogen from a “hold (c)” rating to a “hold (c-)” rating in a report on Wednesday, August 12th. Evercore began coverage on shares of Biogen in a report on Friday, May 15th. They set an “outperform” rating on the stock. Finally, Oppenheimer reissued an “outperform” rating and issued a $300.00 target price on shares of Biogen in a research report on Wednesday, July 29th. One investment analyst has rated the stock with a Strong Buy rating, eighteen have given a Buy rating, thirteen have assigned a Hold rating and one has issued a Sell rating to the stock. According to data from MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and an average price target of $227.79.

Get Our Latest Report on Biogen

Biogen Company Profile (Free Report)

Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer’s disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.

The company’s marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.

See Also Five stocks we like better than Biogen Strike a Balance Between Growth and Stability With These 3 Names Ready to Rally Rubrik’s AI Security Bet Could Power the Next Leg Higher Apple’s Foldable iPhone Could Be a Catalyst, But Not a Cure-All Snowflake Is Up Nearly 50% in 2026—What Are Short Sellers Betting Against? Want to see what other hedge funds are holding BIIB? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Biogen Inc. (NASDAQ:BIIB – Free Report).

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Key Takeaways Eli Lilly and Roche's blood test is FDA-cleared to assess amyloid-beta pathology.Healthcare ETFs offer diversified exposure to companies advancing Alzheimer's diagnostics and therapies.ETFs like IXJ hold companies involved in the growing Alzheimer's market. In a significant development for Alzheimer's diagnostics, the U.S. Food and Drug Administration (FDA) has recently granted clearance to the Elecsys pTau217 blood test, developed jointly by healthcare giants Eli Lilly (LLY - Free Report) and Roche (RHHBY - Free Report) . The test is designed to identify amyloid-beta pathology in individuals aged 55 and older exhibiting signs of cognitive decline, supporting both rule-in and rule-out assessments in primary and specialty care settings.

Notably, it is the first and only FDA-cleared single-biomarker blood test to offer this dual capability using one validated clinical cutoff. 

This regulatory milestone comes against a backdrop of a mounting health crisis, with an estimated 7.4 million Americans aged 65 and older currently living with clinical Alzheimer's dementia, a figure projected to nearly double to 13.8 million by 2060 (as per NIH data). 

With the long-term national care costs for people living with dementia projected to reach $409 billion by the end of this year, the FDA's green light for a more accessible, blood-based diagnostic tool thrusts both Eli Lilly and Roche, and by extension the healthcare exchange-traded funds (ETFs) that hold significant positions in these pharmaceutical giants, into the global investment spotlight. 

But before identifying those particular ETFs, it is important to understand the commercial value of Alzheimer’s diagnostics and therapies and, ultimately, why sector-focused ETFs offer compelling portfolio exposure to this expanding market.

Booming Market for Alzheimer's TreatmentsThe economic landscape surrounding early detection and treatment of Alzheimer's represents one of the largest growth opportunities in modern biopharmaceuticals. To this end, it is imperative to mention that health and long-term care costs for American people living with dementia are projected to reach nearly $1 trillion in 2050.

With Alzheimer's disease being the leading cause of dementia, diagnostic tools like the Elecsys pTau217 getting regulatory approval should exponentially expand the eligible pool of patients for disease-modifying therapies (DMTs). Consequently, this should boost LLY and RHHBY’s revenue growth opportunities, with the global Alzheimer's DMT market projected to surge to $13.1 billion by the end of 2030 (as per BCC Research data). 

Recognizing the growth potential of the Alzheimer’s DMT market, Eli Lilly and Roche, along with other pharmaceutical giants, are also funneling significant capital into this space. For instance, AbbVie (ABBV - Free Report) completed its acquisition of Aliada Therapeutics in late 2024 for $1.4 billion, gaining access to ALIA-1758, an investigational anti-pyroglutamate amyloid beta antibody currently in Phase 1 trials. 

Biogen (BIIB - Free Report) is conducting advanced research to support earlier diagnosis through blood-based biomarkers and investigating therapies directed at key drivers of Alzheimer’s disease biology, including amyloid and tau. Its Lecanemab anti-amyloid antibody, co-developed with Eisai, has recently expanded to include at-home administration options via subcutaneous autoinjector formulations for early-stage Alzheimer's patients. 

Pharma giant Novartis (NVS - Free Report) is evaluating VHB937, a TREM2-targeting candidate currently in Phase 2 clinical trials for early Alzheimer's disease. The company has also entered into a massive licensing and collaboration agreement worth up to $1.7 billion with SciNeuro Pharmaceuticals to develop a next-generation, amyloid-beta-targeting antibody program.

Eli Lilly is independently conducting Phase 3 clinical trials for the efficacy of its donanemab in participants with preclinical Alzheimer's Disease. Notably, donanemab is an FDA-approved monoclonal antibody, designed to clear brain amyloid plaques in early symptomatic Alzheimer's patients. 

Why Healthcare ETFs Offer a Strategic Investment ApproachFor investors looking to gain exposure to the potential upside from the Alzheimer’s treatment market, healthcare ETFs present a compelling option. 

Investing directly in individual biotech or pharmaceutical equities carries inherent concentration risk, as clinical trials can produce mixed efficacy results, regulatory delays, or patent disputes.

Instead, by investing in a healthcare ETF that counts the aforementioned stocks among its top holdings, investors can position themselves to benefit from the collective progress these companies are making in Alzheimer's diagnostics and therapeutics.

Healthcare ETFs to TrackConsidering the aforementioned discussion, investors interested in capitalizing on the growth potential of Alzheimer’s treatment can add the following ETFs to their watchlist and invest once they seem fit:

State Street Health Care Select Sector SPDR ETF (XLV - Free Report)  

This fund, with assets under management (AUM) worth $44.57 billion, offers exposure to 60 companies in the pharmaceuticals; health care equipment and supplies; health care providers and services; biotechnology; life sciences tools and services; and health care technology industries. Of these, LLY holds the first spot with 15.43% weightage, while ABBV holds the third spot with 7.42% weightage. 

XLV has rallied 26.7% over the past year and charges 8 basis points (bps) in fees. 

iShares Global Healthcare ETF (IXJ - Free Report)

This fund, with net assets worth $4.38 billion, offers exposure to 110 pharmaceutical, biotech, and medical device companies worldwide. Of these, LLY holds the first spot with 10.33% weightage, while ABBV holds the third spot with 4.97% weightage. RHHBY holds the fifth position in this fund with 3.90% weightage, while NVS holds the seventh spot with 3.49% weightage. BIIB holds 0.39% of this fund’s assets. 

IXJ has gained 21.4% over the past year and charges 38 bps in fees. 

VanEck Pharmaceutical ETF (PPH - Free Report)

This fund, with net assets worth $1.06 billion, offers exposure to 26 companies involved in pharmaceuticals, including research and development, as well as the production, marketing and sale of pharmaceuticals. Of these, LLY holds the first spot with 19.32% weightage, while NVS holds the third spot with 10.07% weightage. ABBV holds the eighth position in this fund with 4.49% weightage. 

PPH has soared 30.4% over the past year and charges 36 bps in fees. 

iShares Neuroscience and Healthcare ETF (IBRN - Free Report)

This fund, with net assets worth $8 million, offers exposure to 68 global companies advancing research and treatment of neurological disorders. Of these, Praxis Precision Medicines holds the first spot with 5.31% weightage, while BIIB holds the ninth position with 4.14% weightage. 

IBRN has surged 60.6% over the past year and charges 47 bps in fees. 

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.)

, /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 INFORMATION

WARNING: 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 ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 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 ε4 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 ε4 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 ε4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 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 ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 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 ε4 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 ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 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 REACTIONS

The 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/mL Subcutaneous injection: 200 mg/mL Please 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 Department

TEL: +81 (0)3-3817-5120 

Biogen Inc.

Madeleine Shin

+1-781-464-3260

[email protected]  

Eisai Europe, Ltd.

EMEA Communications Department

+44 (0) 7760 619251

[email protected]

Eisai Inc. (U.S.)

Julie Edelman

+1-862-213-5915

[email protected] 

INVESTOR CONTACTS

Eisai Co., Ltd.

Investor Relations Department

TEL: +81 (0) 3-3817-5122

Biogen Inc.

Tim Power

+ 1-781-464-2442

[email protected]

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 (Aβ).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<0.00001).* Additionally, LEQEMBI continued to show benefit over a four-year LTE treatment period; in a subgroup analysis, 81 percent of LEQEMBI patients who stayed on treatment remained in the early AD stages at four years.**

Over three years of treatment, including both the core study and the LTE, 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-year mark. In Clarity AD, the most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

*The Centiloid scale is used for amyloid PET, where 0 CL is anchored as the average amyloid in young people without amyloid plaques, and 100 is anchored as the average amyloid level in moderate AD.  The baseline centiloid level in CLARITY AD was approximately 78 CL. Plaque negativity is defined as conversion to amyloid PET negative (<30 centiloid, or CL).

**Prespecified subgroup analysis of reduced risk of progression: Progression was defined as CDR-SB score progressing to moderate or severe dementia (≥9.5), based on Kaplan-Meier plots.

About Protofibrils
Protofibrils are thought to be the most toxic Aβ 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.2 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ 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.3 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.

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, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. 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.

References

National Institute on Aging (NIA), National Institutes of Health. What Is Mild Cognitive Impairment? Available at: https://www.nia.nih.gov/health/memory-loss-and-forgetfulness/what-mild-cognitive-impairment. Accessed July 22, 2026. Amin L, Harris DA. Aβ 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-β 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. SOURCE Eisai Inc.

Allworth Financial LP acquired a new stake in Biogen Inc. (NASDAQ:BIIB – Free Report) in the 2nd quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The fund acquired 8,033 shares of the biotechnology company’s stock, valued at approximately $1,736,000.

A number of other hedge funds have also added to or reduced their stakes in the stock. Bell Investment Advisors Inc purchased a new position in Biogen during the second quarter valued at approximately $27,000. Reflection Asset Management purchased a new stake in Biogen during the fourth quarter worth $25,000. WPG Advisers LLC boosted its position in Biogen by 417.9% during the 4th quarter. WPG Advisers LLC now owns 145 shares of the biotechnology company’s stock valued at $26,000 after acquiring an additional 117 shares in the last quarter. First Horizon Corp bought a new stake in Biogen during the 4th quarter valued at $30,000. Finally, Root Financial Partners LLC increased its holdings in shares of Biogen by 198.4% in the 4th quarter. Root Financial Partners LLC now owns 185 shares of the biotechnology company’s stock valued at $33,000 after acquiring an additional 123 shares during the period. 87.93% of the stock is currently owned by institutional investors.

Wall Street Analysts Forecast Growth Several analysts have commented on BIIB shares. HSBC reissued a “reduce” rating and set a $157.00 price target on shares of Biogen in a research report on Monday, July 6th. UBS Group lifted their price objective on shares of Biogen from $225.00 to $240.00 and gave the stock a “buy” rating in a research report on Thursday, July 30th. TD Cowen boosted their price objective on shares of Biogen from $215.00 to $225.00 and gave the stock a “buy” rating in a research note on Thursday, July 30th. Needham & Company LLC increased their target price on shares of Biogen from $255.00 to $256.00 and gave the company a “buy” rating in a research report on Monday, June 29th. Finally, Freedom Capital upgraded shares of Biogen from a “hold” rating to a “strong-buy” rating in a research note on Friday, May 1st. One analyst has rated the stock with a Strong Buy rating, eighteen have given a Buy rating, thirteen have assigned a Hold rating and one has assigned a Sell rating to the company. According to MarketBeat, the company currently has an average rating of “Moderate Buy” and an average target price of $227.07.

Check Out Our Latest Analysis on BIIB Biogen Stock Performance BIIB opened at $216.78 on Friday. The firm has a fifty day moving average price of $205.53 and a 200 day moving average price of $194.48. Biogen Inc. has a 1 year low of $131.52 and a 1 year high of $222.15. The stock has a market cap of $32.03 billion, a P/E ratio of 38.37, a P/E/G ratio of 6.68 and a beta of 0.17. The company has a debt-to-equity ratio of 0.39, a current ratio of 1.87 and a quick ratio of 1.26.

Biogen (NASDAQ:BIIB – Get Free Report) last announced its quarterly earnings results on Wednesday, July 29th. The biotechnology company reported $3.60 earnings per share for the quarter, beating the consensus estimate of $2.94 by $0.66. The firm had revenue of $2.74 billion during the quarter, compared to analyst estimates of $2.46 billion. Biogen had a return on equity of 11.18% and a net margin of 8.32%.Biogen’s revenue for the quarter was up 3.4% compared to the same quarter last year. During the same quarter in the previous year, the business earned $5.47 EPS. Biogen has set its FY 2026 guidance at 12.000-13.000 EPS. Equities research analysts anticipate that Biogen Inc. will post 12.39 earnings per share for the current year.

About Biogen (Free Report)

Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer’s disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.

The company’s marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.

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BIIB's newer drugs, M&A activity and pipeline progress are fueling its turnaround, but declining MS sales remain a key risk.

Lead program now in Phase 1 development August 06, 2026 18:15 ET  | Source: Biogen Inc.

CAMBRIDGE, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the completion of the acquisition of RayThera Inc., a privately held biotechnology company focused on discovering and developing small-molecule therapies in immunology.

The acquisition strengthens Biogen’s growing immunology portfolio, adding multiple assets that have potential to treat immune-mediated conditions across a range of indications. The lead program entered Phase 1 development in July 2026.

“We are excited about the potential of these immunology assets as we continue to strengthen and diversify our pipeline for long-term growth,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “With the lead program now in Phase 1, this acquisition highlights strong execution on our open innovation model in sourcing external opportunities and reflects our continued investment in immunology as a strategic growth area.”

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, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This press release contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 (the PSLRA) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the PSLRA. This press release contains forward-looking statements, including relating to: the anticipated benefits of the RayThera Inc. acquisition (the “Acquisition”); our growing immunology portfolio, including the potential strengthening and diversification of our pipeline for long-term growth; our investment in immunology as a strategic growth area; and the anticipated financial impacts of the Acquisition. 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,” 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, factors relating to: the possibility that the thresholds for clinical and regulatory milestone payments are never met; results of litigation, settlements and investigations; actions by third parties, including governmental agencies; unexpected costs, charges or expenses resulting from the Acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Acquisition; the risk that Biogen may not be able to successfully integrate the business of RayThera and realize the expected benefits of the Acquisition in a timely manner or at all; 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 date hereof 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, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. 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.

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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.

One of these enterprises was Biogen (BIIB +1.76%), which did quite well in its second quarter. As a reward, investors snapped up the stock, sending it to a nearly 2% gain on the day. This beat the S&P 500 index's 0.2% rise.

A biotech in transition Before market open that day, Biogen published those quarterly figures. For the period, the big biotech's revenue was $2.7 billion, 3% higher year over year. The story was quite different on the bottom line, as net income not under generally accepted accounting principles (non-GAAP, or adjusted) slipped to $536 million, or $3.60 per share, from the year-ago profit of $803 million.

Image source: Getty Images.

Despite the bottom-line swoon, Biogen beat on both revenue and profitability. Analysts tracking the stock were, as a group, estimating $2.4 billion for the former line item and $3.17 per share for adjusted earnings per share (EPS).

As has been the case lately for the company, its growth portfolio of medicines was the motor driving the top-line improvement. Drugs in that category collectively raked in $1.06 billion in revenue, a 24% year-over-year improvement.

Higher expenses for items such as upfront and milestone payments, plus higher interest payments from financing needed to acquire Apellis Pharmaceuticals, affected the biotech's adjusted net income line.

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Making the right moves Biogen updated its full-year guidance. It now expects revenue to rise at a mid-single-digit percentage rate over 2025, where previously it expected a decline at roughly the same rate.

Some of the same factors that drove down second-quarter adjusted earnings were also the key reasons for management's reduction in annual adjusted net income. This guidance was lowered to $12 to $13 per share, from the preceding $14.25 to $15.25.

Usually when a company cuts guidance, particularly for the bottom line, investors react negatively. It's telling that this didn't happen in this case because Mr. Market realizes -- correctly, I believe -- that Biogen's pivot is working, and the growth portfolio will continue to do exactly what it says on the label.

Revenue Tops Expectations On Growth Across Key ProductsThe Alzheimer’s drug maker reported revenues of $2.736 billion, beating the consensus of $2.458 billion, up 3% on a reported and 2% on a constant currency basis.

Spinraza revenue of $402 million, up 2% year-over-year, driven by demand and stocking for the high-dose regimen, partially offset by shipment timing in certain ex-U.S. markets; conversion to the high-dose

regimen has been ahead of company expectations in all launched geographies.

Vumerity revenue of $197 million, down 7% year-over-year, primarily impacted by inventory dynamics; first half growth of 7% year-over-year.

Leqembi (Alzheimer’s drug) revenue was $184 million, with U.S. in-market sales of around $97 million.

Revenues from Skyclarys (Friedreich’s ataxia drug), acquired via the Reata acquisition, reached $168 million, up 29%.

Zurzuvae’s (postpartum depression drug) revenue of $71 million, up 53%, was driven by demand growth.

Biogen completed the acquisition of Apellis, adding Syfovre and Empaveli to its portfolio, which contributed $128 million in revenue and are expected to grow in the mid- to high-teens through 2028.

Biogen Raises Full-Year GuidanceThe company raised its fiscal 2026 adjusted earnings guidance from $15.25-$16.25 to $15.85-$16.85, compared to the consensus of $12.83.

Full-year total revenue is now expected to increase by a mid-single-digit percentage for 2026 vs. 2025.

Pipeline AdvancesBiogen also shared Phase 2 data for BIIB091 in relapsing-remitting multiple sclerosis, which showed that BIIB091 has achieved proof-of-concept, and the company will be exploring next steps for the asset.

As part of the option exercise, Biogen paid Ionis a $15 million one-time license fee.

Barclays maintains Equal-Weight on Biogen, while raising the price forecast from $185 to $200.

BIIB Price Action: Biogen shares were up 1.99% at $209.70 at the time of publication on Wednesday, according to Benzinga Pro data.

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Biogen Inc. (BIIB - Free Report) reported $2.74 billion in revenue for the quarter ended June 2026, representing a year-over-year increase of 3.4%. EPS of $3.60 for the same period compares to $5.47 a year ago.

The reported revenue compares to the Zacks Consensus Estimate of $2.5 billion, representing a surprise of +9.4%. The company delivered an EPS surprise of +18.42%, with the consensus EPS estimate being $3.04.

While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.

As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately.

Here is how Biogen performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenue- Product- Rare Disease- SPINRAZA- United States: $204.3 million versus $149.18 million estimated by 22 analysts on average. Compared to the year-ago quarter, this number represents a +36.8% change.Revenue- Product- Multiple Sclerosis (MS)- United States: $621 million compared to the $573 million average estimate based on 21 analysts. The reported number represents a change of -5.5% year over year.Revenue- Product- Rare Disease- SKYCLARYS - United States: $82.3 million versus the 21-analyst average estimate of $84.27 million. The reported number represents a year-over-year change of +5.5%.Revenue- Product- Multiple Sclerosis (MS)- Interferon- United States: $146.1 million versus the 21-analyst average estimate of $138.46 million. The reported number represents a year-over-year change of -2.6%.Revenue- Anti-CD20 therapeutic programs: $513.5 million compared to the $473.33 million average estimate based on 25 analysts. The reported number represents a change of +9.9% year over year.Revenue- Contract manufacturing, royalty and other revenue: $242.4 million versus $151.82 million estimated by 23 analysts on average.Revenue- Product- Multiple Sclerosis (MS)- Fumarate- Total: $287.4 million compared to the $308.1 million average estimate based on 23 analysts. The reported number represents a change of -29.2% year over year.Alzheimer's collaboration revenue: $63.7 million versus $65.97 million estimated by 23 analysts on average. Compared to the year-ago quarter, this number represents a +16% change.Revenue- Product- Rare Disease- SKYCLARYS- Total: $167.9 million versus $154.66 million estimated by 23 analysts on average. Compared to the year-ago quarter, this number represents a +28.9% change.Revenue- Product- Rare Disease- SPINRAZA- Total: $401.9 million compared to the $379.46 million average estimate based on 23 analysts. The reported number represents a change of +2.3% year over year.Revenue- Product- Multiple Sclerosis (MS)- TYSABRI- Total: $450.8 million versus the 23-analyst average estimate of $374.73 million. The reported number represents a year-over-year change of -0.8%.Revenue- Product- Biosimilars- Total: $152.8 million versus the 22-analyst average estimate of $160.18 million. The reported number represents a year-over-year change of -15.9%.View all Key Company Metrics for Biogen here>>>

Shares of Biogen have returned -4.8% over the past month versus the Zacks S&P 500 composite's +1.9% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.

Key Takeaways South Korean Measures to Cap Volatility for 1st TimeDiscussions Abound Whether the Fed May Raise Interest RatesPG Mixed, HUM and BIIB Beat, VFC Misses on Quarterly Numbers Wednesday, July 29th, 2026

Pre-market futures are flat-to-down ahead of today’s open, with overseas turbulence in the memory chip market reverberating on domestic shores. We also see something of a hesitation in trading ahead of this afternoon’s Fed decision on interest rates. The Dow is off -340 points at this hour, the tech-heavy Nasdaq is -7, while the S&P 500 and small-cap Russell 2000 are flat.

Saudi Arabia attacked Iran-backed forced in Iraq, demonstrating a further widening of the conflict that originally had been contained to the U.S. and Israel versus Iran. Spot oil prices are back up again this morning, but still just in the $80s per barrel (/bbl); a week ago, Brent crude had surged back over $100/bbl.

South Korean Finance Takes Measures to Calm Market
The finance minister of South Korea overnight has initiated caps on single-stock leveraged ETFs — a clear move to quiet market volatility related to SK Hynix (SKHY - Free Report) , one of the top memory chip producers in the world, which is a key component in the AI trade. The Korean stock market, KOSPI, was down another -6%, -15% over the last week.

This is reportedly the first time the country has applied the breaks to a particular stock trading entity, and it comes the day SK Hynix missed on both top and bottom lines in its first publicly trading earnings report this morning. Both operating profits and sales, however, rose triple-digits in the quarter. The company, one of the biggest suppliers to NVIDIA (NVDA - Free Report) , is down -1% on the news, -22% since its IPO less than three weeks ago.

FOMC Decision: No Longer a Slam Dunk?
The Federal Open Market Committee (FOMC) concludes its fifth meeting so far in 2026, and the first one where analysts have an inkling something might change on the Fed funds rate. Particularly, a quarter-points rate hike has been bandied about as a possibility today over the past week or so, likely due to inflation rates dancing up around +4% over the past couple months and uncertainties around the Strait of Hormuz.

With Fed Chair Kevin Warsh’s new methodology intentionally less transparent than the last three Fed chairs (Ben Bernanke, Janet Yellen and Jerome Powell), it’s tough to get a read on what results his leadership will glean this afternoon at 2pm ET. But from this vista, despite whether more hawkish members of the Fed cast their votes to raise interest rates, it’s hard to see a Warsh-led consensus bringing this about so early into his tenure. Unless he’s looking for a fight from President Trump.

Q2 Roundup at a Glance: PG, HUM & More
Procter & Gamble (PG - Free Report) beat on fiscal Q4 earnings this morning by 2 cents per share, while missing slightly on its top line to $21.2 billion, above the $20.89 billion reported a year ago. For more on PG’s earnings, click here.

Health insurance giant Humana (HUM - Free Report) posted a huge Q2 earnings beat this morning: $7.61 per share versus $6.22 in the Zacks consensus, for a +22.35% positive earnings surprise. Revenues of $40.89 billion outpaced expectations by +0.59%. For more on HUM’s earnings, click here.

Biotech major Biogen (BIIB - Free Report) provided one of the strongest quarterly reports of the morning, with Q2 earnings of $3.60 per share well above the $3.04 projected, on revenues of $2.74 billion which outperformed estimates by +9.4%. For more on BIIB’s earnings, click here.

Vans, Timberland and The North Face parent V.F. Corp. (VFC - Free Report) posted its first earnings miss in the last four quarters: -$0.27 per share versus -$0.22 expected. Revenues of $1.67 billion was -0.29% below consensus. For more on VFC’s earnings, click here.

After the close, we’ll see results from two key “Mag 7” companies, Microsoft (MSFT - Free Report) and Meta Platforms (META - Free Report) , In addition, reports are also due from Qualcomm (QCOM - Free Report) and Starbucks (SBUX - Free Report) , among others, this afternoon.

Questions or comments about this article and/or author? Click here>>

Biogen Inc. (BIIB - Free Report) came out with quarterly earnings of $3.6 per share, beating the Zacks Consensus Estimate of $3.04 per share. This compares to earnings of $5.47 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +18.42%. A quarter ago, it was expected that this company would post earnings of $2.95 per share when it actually produced earnings of $3.57, delivering a surprise of +21.02%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Biogen, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $2.74 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 9.40%. This compares to year-ago revenues of $2.65 billion. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Biogen shares have added about 16.8% since the beginning of the year versus the S&P 500's gain of 8.5%.

What's Next for Biogen?While Biogen has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Biogen was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $3.19 on $2.56 billion in revenues for the coming quarter and $11.59 on $10.08 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, Kamada (KMDA - Free Report) , is yet to report results for the quarter ended June 2026.

This biopharmaceutical is expected to post quarterly earnings of $0.12 per share in its upcoming report, which represents a year-over-year change of -7.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Kamada's revenues are expected to be $51.62 million, up 15.4% from the year-ago quarter.

A test tube is seen in front of displayed Biogen logo in this illustration created on December 1, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Purchase Licensing Rights, opens new tab

CompaniesJuly 29 (Reuters) - Biogen (BIIB.O), opens new tab reported second-quarter profit and revenue that topped Wall Street estimates on Wednesday, driven by strong demand for its rare-disease ​medicines, while sales of its legacy multiple sclerosis drugs ‌stayed under pressure.

Investors are closely watching whether recent deals and newer products including its Alzheimer's drug Leqembi can reignite growth and help the company ​navigate mounting competition and pricing pressure across its aging multiple ​sclerosis portfolio.

Jumpstart your morning with the latest legal news delivered straight to your inbox from The Daily Docket newsletter. Sign up here.

Despite an upbeat quarter, Biogen cut its 2026 adjusted per-share ⁠profit forecast to between $12 and $13 from between $14.25 and $15.25 per share ​earlier, reflecting a $3.85 per share impact from acquisition-related charges.

Analysts were expecting ​2026 profit of $12.72 per share, according to data compiled by LSEG.

The drugmaker said its $5.6 billion buyout of Apellis Pharmaceuticals earlier this year would account for ​an 85-cent-per-share hit to annual profit.

The deal, Biogen's largest since its ​2023 buyout of Reata Pharmaceuticals, gave it a foothold in kidney disease treatment and access ‌to ⁠two approved rare disease drugs, which generated a combined revenue of about $689 million last year.

Global sales of Biogen's Alzheimer's drug Leqembi, developed with Eisai (4523.T), opens new tab, rose 15% from a year earlier to about $184 ​million as demand ​gained traction after ⁠early concerns over cost, efficacy and side effects tempered its launch.

Biogen expects recent U.S. approvals for a ​more convenient under-the-skin formulation of Leqembi to drive patient ​uptake.

On an ⁠adjusted basis, it earned $3.60 per share for the quarter ended June 30, compared with an expectation of $2.95 per share.

Quarterly revenue came in ⁠at $2.74 ​billion, above an estimate of $2.46 billion.

Sales of ​legacy multiple sclerosis drugs such as Tecfidera fell 13% to $963 million compared to the ​previous year.

Reporting by Mariam Sunny in Bengaluru; Editing by Pooja Desai

Our Standards: The Thomson Reuters Trust Principles., opens new tab

Biogen Inc (BIIB) released its 8-K filing on July 29, 2026, indicating notable performance in its recent quarter amid ongoing challenges in its legacy business.

Biogen Inc. (BIIB - Free Report) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.

The earnings report, which is expected to be released on July 29, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.

While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.

Zacks Consensus EstimateThis company is expected to post quarterly earnings of $3.13 per share in its upcoming report, which represents a year-over-year change of -42.8%.

Revenues are expected to be $2.43 billion, down 8.1% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 9.33% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Biogen?For Biogen, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -3.60%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination makes it difficult to conclusively predict that Biogen will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Biogen would post earnings of $2.95 per share when it actually produced earnings of $3.57, delivering a surprise of +21.02%.

Over the last four quarters, the company has beaten consensus EPS estimates four times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Biogen doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Expected Results of an Industry PlayerAmong the stocks in the Zacks Medical - Biomedical and Genetics industry, GSK (GSK - Free Report) , is soon expected to post earnings of $1.27 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +3.3%. This quarter's revenue is expected to be $10.77 billion, up 1% from the year-ago quarter.

Over the last 30 days, the consensus EPS estimate for Glaxo has been revised 2.8% up to the current level. Nevertheless, the company now has an Earnings ESP of -0.20%, reflecting a lower Most Accurate Estimate.

When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Glaxo will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.

Posted by Defense World Staff on Jul 20th, 2026

California Public Employees Retirement System raised its position in Biogen Inc. (NASDAQ:BIIB – Free Report) by 3.1% in the first quarter, according to the company in its most recent filing with the Securities and Exchange Commission (SEC). The fund owned 340,903 shares of the biotechnology company’s stock after buying an additional 10,097 shares during the period. California Public Employees Retirement System owned approximately 0.23% of Biogen worth $62,498,000 at the end of the most recent quarter.

Other large investors also recently modified their holdings of the company. SG Americas Securities LLC boosted its stake in shares of Biogen by 1,793.8% during the 4th quarter. SG Americas Securities LLC now owns 183,829 shares of the biotechnology company’s stock valued at $32,352,000 after buying an additional 174,122 shares during the last quarter. LSV Asset Management increased its stake in shares of Biogen by 3.3% in the fourth quarter. LSV Asset Management now owns 316,815 shares of the biotechnology company’s stock worth $55,756,000 after buying an additional 9,976 shares during the last quarter. Catalyst Funds Management Pty Ltd bought a new stake in shares of Biogen in the fourth quarter worth $2,006,000. Systematic Financial Management LP raised its holdings in Biogen by 256.3% in the fourth quarter. Systematic Financial Management LP now owns 16,640 shares of the biotechnology company’s stock valued at $2,928,000 after acquiring an additional 11,970 shares in the last quarter. Finally, Contrarius Group Holdings Ltd acquired a new stake in Biogen in the fourth quarter valued at $11,431,000. 87.93% of the stock is currently owned by institutional investors and hedge funds.

Biogen Price Performance BIIB stock opened at $205.99 on Monday. The firm has a market cap of $30.41 billion, a price-to-earnings ratio of 22.10 and a beta of 0.16. Biogen Inc. has a 1-year low of $121.05 and a 1-year high of $219.72. The firm has a fifty day moving average price of $199.43 and a two-hundred day moving average price of $189.09. The company has a debt-to-equity ratio of 0.34, a current ratio of 3.06 and a quick ratio of 2.41.

Biogen (NASDAQ:BIIB – Get Free Report) last posted its quarterly earnings results on Wednesday, April 29th. The biotechnology company reported $3.57 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $2.95 by $0.62. Biogen had a net margin of 13.81% and a return on equity of 12.83%. The company had revenue of $2.48 billion for the quarter, compared to the consensus estimate of $2.29 billion. During the same period last year, the firm posted $3.02 EPS. The company’s revenue for the quarter was up 1.9% on a year-over-year basis. Biogen has set its FY 2026 guidance at 14.250-15.250 EPS. Research analysts predict that Biogen Inc. will post 13.45 EPS for the current year.

Wall Street Analyst Weigh In BIIB has been the subject of several recent analyst reports. JPMorgan Chase & Co. raised their price objective on shares of Biogen from $175.00 to $185.00 and gave the stock a “neutral” rating in a report on Thursday, April 23rd. Cantor Fitzgerald restated an “overweight” rating on shares of Biogen in a research note on Monday, June 22nd. Truist Financial upgraded shares of Biogen from a “hold” rating to a “buy” rating and upped their target price for the company from $190.00 to $235.00 in a research note on Monday, July 13th. Evercore began coverage on shares of Biogen in a research report on Friday, May 15th. They set an “outperform” rating on the stock. Finally, Zacks Research downgraded Biogen from a “hold” rating to a “strong sell” rating in a research note on Monday, June 29th. One equities research analyst has rated the stock with a Strong Buy rating, seventeen have assigned a Buy rating, eleven have assigned a Hold rating and two have given a Sell rating to the stock. According to data from MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and an average target price of $220.04.

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About Biogen (Free Report)

Biogen Inc is a multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases. Headquartered in Cambridge, Massachusetts, the company has a longstanding emphasis on neuroscience, with research and commercial activities spanning multiple therapeutic areas including multiple sclerosis, spinal muscular atrophy and Alzheimer’s disease. Biogen was founded in 1978 and has grown into a global biopharmaceutical firm with operations and commercial presence across North America, Europe, Japan and other international markets.

The company’s marketed portfolio has historically included several well-known therapies for multiple sclerosis such as Avonex, Tysabri and Tecfidera, and it has pursued treatments for rare neurological conditions and genetic neuromuscular disorders.

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Key Takeaways Biogen presented CELIA data at AAIC, confirming that diranersen missed the phase II primary endpoint.BIIB confirmed the lowest 60mg dose showed the largest numerical slowing across cognitive measures.Biogen has still not disclosed a timeline to begin phase III development for diranersen. Shares of Biogen (BIIB - Free Report) were down 8.2% yesterday after the company presented data from the phase II CELIA study evaluating its experimental tau-targeting Alzheimer’s disease (AD) drug, diranersen, at the Alzheimer’s Association International Conference (AAIC).

The AAIC data confirmed that CELIA did not meet its primary endpoint, which assessed the dose-response for change from baseline at week 76 on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score, a widely used clinical scale that measures cognitive and functional decline in AD patients.

More on BIIB’s Data PresentationWhile the investigational tau-targeting therapy demonstrated meaningful reductions in cognitive decline across multiple measures—including a 26% slowing on CDR-SB, 42% on ADAS-Cog13 and 50% on MMSE at the 60 mg dose — along with robust reductions in cerebrospinal fluid tau and brain tau pathology, the study failed to meet its primary endpoint of demonstrating a dose-response relationship because higher doses did not produce greater clinical benefit.

Importantly, in May 2026, Biogen had already confirmed that CELIA failed to meet its primary endpoint and the latest data presentation did not alter that outcome.

The lowest dose (60 mg every six months) generated the strongest clinical results, while the two higher-dose regimens showed progressively smaller benefits. In the press release, Biogen did confirm that “higher doses were not associated with greater slowing of decline.” The 60 mg regimen slowed CDR-SB decline by 26%, while the two 115 mg regimens, given every six months and every three months, showed only 14% and 9% slowing, respectively. Similar variability appeared across other cognitive measures.

Also, it can be inferred that investors seemed more worried about Biogen’s plans to advance diranersen into confirmatory phase III development, as the study failed to demonstrate the expected dose-dependent clinical benefit. The stronger efficacy observed with the lowest dose than with higher doses may have added to the uncertainty surrounding the drug's late-stage prospects.

Biogen has still not disclosed a timeline for initiating the late-stage development program for diranersen.

BIIB’s Stock PerformanceShares of Biogen have risen 9% year to date compared with the industry’s 2.9% growth.

Image Source: Zacks Investment Research

More on Biogen’s Development Activities With DiranersenDiranersen remains among the more advanced tau-targeting therapies currently in development for AD, an area many researchers believe could complement existing amyloid-focused treatments or potentially provide improved disease-modifying benefits.

Biogen is developing diranersen in collaboration with Ionis Pharmaceuticals (IONS - Free Report) .

Biogen currently markets AD therapy Leqembi, which has been developed in collaboration with Japan-based Eisai, with the latter leading the clinical development and regulatory submissions.

Unlike Leqembi, which targets amyloid-beta plaques, diranersen is designed to reduce the production of tau, which is strongly linked to AD progression and cognitive decline.

Another marketed amyloid-targeting AD therapy is Eli Lilly’s (LLY - Free Report) Kisunla. Eli Lilly is also developing experimental candidates targeting tau as interest in alternative AD mechanisms continues to grow across the industry.

BIIB’s Zacks RankBiogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Biogen Inc. (BIIB) Alzheimer's Association International Conference (AAIC Meeting) 2026 July 12, 2026 11:15 AM EDT

Company Participants

Tim Power - Head of Investor Relations
Priya Singhal - Executive VP & Head of Development
Diana Gallagher - Head of Clinical Development of MS&I and AD

Conference Call Participants

Evan Seigerman - BMO Capital Markets Equity Research
Salveen Richter - Goldman Sachs Group, Inc., Research Division
Eric Schmidt - Cantor Fitzgerald & Co., Research Division
Michael DiFiore - Evercore ISI Institutional Equities, Research Division
Paul Matteis - Stifel, Nicolaus & Company, Incorporated, Research Division
Terence Flynn - Morgan Stanley, Research Division
Michael Yee - UBS Investment Bank, Research Division
Taylor Hanley - JPMorgan Chase & Co, Research Division
Sadia Rahman - Wells Fargo Securities, LLC, Research Division
Lin Tsai - Jefferies LLC, Research Division
Alexandra von Riesemann - Piper Sandler & Co., Research Division
Emily Field - Barclays Bank PLC, Research Division
Alexandria Hammond - Wolfe Research, LLC
Philip Nadeau - TD Cowen, Research Division
Jason Zemansky - BofA Securities, Research Division
Myles Minter - William Blair & Company L.L.C., Research Division
Maddalena Delma Caiati - Guggenheim Securities, LLC, Research Division
Jay Olson - Oppenheimer & Co. Inc., Research Division

Presentation

Operator

Good morning. My name is Jess, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen and AAIC 2026 Webcast. [Operator Instructions] Today's conference is being recorded. Thank you.

I would now like to turn the conference over to Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

Tim Power
Head of Investor Relations

Thanks, Jess, and good afternoon, everybody. Thanks for joining us today. I'd like to start by just pointing out that we'll be making forward-looking statements, which are based on our expectations. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in

14.7.2026 22:09

Zámořské akciové trhy během dnešního obchodování posílily, k čemuž přispěla nečekaně nízká čísla o červnové inflaci v USA, která zmírnila obavy z dalšího zvyšování úrokových sazeb ze strany Fedu. Širší index S&P 500 vzrostl o 0,38 % na 7543,86 bodu a technologický Nasdaq Composite si připsal 0,9 % na 26107,01 bodu, zatímco index Dow Jones zakončil se ziskem 0,02 % na hodnotě 52508,27 bodu. Pozitivní náladu na trhu podpořily také solidní hospodářské výsledky velkých bank na začátku nové výsledkové sezóny.

Z jednotlivých odvětví indexu S&P 500 zaznamenaly nejvýraznější růst informační technologie o 1,3 %, následované komunikačními službami, které přidaly 1,1 %, a finančním sektorem se ziskem 0,4 %. Naopak nejvíce oslabila zdravotní péče, která odepsala 1,9 %. V červených číslech skončila také nezbytná spotřeba se ztrátou 1,4 % a reality, které klesly o 0,4 %.

Mezi nejúspěšnější tituly dne se zařadila kyberbezpečnostní společnost Crowdstrike Holdings (CRWD) s nárůstem o 12 %. Výrazně posílila také investiční banka Goldman Sachs Group (GS) o 9,0 %, prodejce aut Carvana (CVNA) o 8,3 %, Palo Alto Networks (PANW) o 6,8 % a Monolithic Power Systems (MPWR) se ziskem 7,1 %. Na druhé straně po slabších kvartálních tržbách prudce propadla společnost IBM (IBM), která odepsala 25 %. Nedařilo se ani společnosti Biogen (BIIB) se ztrátou 8,2 %, HCA Healthcare (HCA) s poklesem o 7,0 %, Intuitive Surgical (ISRG) o 6,8 % a GE HealthCare Technologies (GEHC), která oslabila o 6,1 %.

Na komoditním trhu rostla severoamerická lehká ropa WTI o 1,9 % na 79,65 dolaru za barel a spotové zlato posílilo o 1,3 % na 4054,53 dolaru za unci. Americký dolar pod vlivem inflačních dat oslabil. Euro vůči němu vzrostlo o 0,4 % na 1,1424 dolaru a britská libra si připsala 0,3 % na 1,3383 dolaru, zatímco japonský jen posílil o 0,1 % na 162,19 jenu za dolar. Výnosy desetiletých američních vládních dluhopisů v reakci na nižší inflaci klesly o čtyři bazické body na 4,58 %. Bitcoin zaznamenal nárůst o 3,9 % na 64554,91 dolaru.

Index Dow Jones +0,02 % na 52508,27 b.
S&P 500 +0,38 % na 7543,86 b.
Nasdaq Composite +0,9 % na 26107,01 b.

Index S&P 500 +0,38 % na 7543,86 b. Nejsilnější sektory S&P Změna Nejslabší sektory S&P Změna Informační technologie +1,3 % Zdravotní péče -1,9 % Komunikační služby +1,1 % Nezbytná spotřeba -1,4 % Energie +0,4 % Reality -0,4 % Nejsilnější akcie S&P Změna Nejslabší akcie S&P Změna Crowdstrike Holdings (CRWD) +12 % IBM (IBM) -25 % Goldman Sachs Group (GS) +9,0 % Biogen (BIIB) -8,2 % Carvana (CVNA) +8,3 % HCA Healthcare (HCA) -7,0 % Dell Technologies (DELL) +7,1 % Intuitive Surgical (ISRG) -6,8 % Palo Alto Networks (PANW) +6,8 % Stryker Corp (SYK) -6,1 %
Daniel Marván
Fio banka, a.s.
Prohlášení

Key Takeaways Biogen won FDA approval for Leqembi Iqlik as a weekly SC starter dose for early Alzheimer's disease.BIIB said the SC autoinjector delivers treatment in about 15 seconds and can be used at home.BIIB plans to launch Leqembi Iqlik by the end of next month after studies matched IV drug exposure. Shares of Biogen (BIIB - Free Report) rose nearly 5% yesterday after the company announced that the FDA approved a subcutaneous (SC) autoinjector version of Leqembi as an initiation dosing option for the treatment of early Alzheimer’s disease (AD). The SC version of the drug is marketed under the brand name Leqembi Iqlik.

Previously, patients initiating Leqembi therapy were required to receive intravenous (IV) infusions once every two weeks for 18 months before transitioning to monthly IV maintenance dosing or weekly SC maintenance dosing. With the latest approval, patients now start treatment with a once-weekly SC autoinjector, eliminating the need for biweekly IV infusions during the initiation phase.

The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming, nearly one hour for each infusion. According to Biogen, this SC version can be administered in about 15 seconds and can even be used by patients at home or in medical centers. Patients may also switch from IV to SC administration or vice versa, providing greater convenience and flexibility in Leqembi administration.

BIIB’s Stock PerformanceThe latest approval marks an important milestone for Leqembi, as patients can now receive the entire course of treatment through the SC formulation, including at-home administration, if appropriate. While Leqembi Iqlik requires weekly administration, it can be delivered in about 15 seconds using an autoinjector, offering a more convenient alternative to hour-long IV infusions. Investors likely cheered the approval, driving Biogen's shares higher.

Year to date, the stock has risen 19% compared with the industry’s 2% growth.

Image Source: Zacks Investment Research

More on BIIB’s LeqembiThe latest FDA approval is supported by data from multiple clinical studies, which indicated that weekly dosing with Leqembi Iqlik achieved drug exposure equivalent to that of the IV version. Biogen plans to commercially launch this version by the end of next month.

Leqembi was initially approved by the FDA in 2023 as a biweekly IV medication (for both initial and maintenance dosing) to treat AD patients with mild cognitive impairment (MCI) or the mild dementia stage of the disease (collectively referred to as ‘early AD’). The drug is approved for a similar indication in the European Union.

Biogen has developed Leqembi in collaboration with Japan-based Eisai, with the latter leading the clinical development and regulatory submissions. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.

Biogen Bets on Tau in Next Phase of AD Drug DevelopmentLeqembi is an amyloid-targeting therapy designed to slow disease progression by removing amyloid-beta plaques. Another approved amyloid-targeting AD treatment is Eli Lilly's (LLY - Free Report) Kisunla, which poses significant competition to the Biogen/Eisai drug. Both companies are exploring additional disease mechanisms that could further improve AD patient outcomes.

Recently, Biogen made headlines after deciding to advance its experimental tau-targeting therapy, diranersen, into late-stage development despite the candidate missing the primary endpoint in a mid-stage study. Although the study did not demonstrate the expected dose-dependent clinical benefit, pre-specified analyses of cognitive endpoints showed a reduction in clinical decline across all studied doses, particularly among participants receiving the lowest drug dose. The drug is being developed in collaboration with Ionis Pharmaceuticals (IONS - Free Report) .

Diranersen remains among the more advanced tau-targeting therapies currently in development for AD, an area that many researchers believe could complement existing amyloid-focused treatments or potentially provide improved disease-modifying benefits.

BIIB’s Zacks RankBiogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Clinical outcomes: Diranersen demonstrated efficacy across all studied doses at 18 months, with consistent results across multiple prespecified clinical endpoints; the 60 mg dose showed the strongest response with slowing of clinical decline on the cognitive endpoints—42% on ADAS-Cog13 and 50% on MMSE—alongside a 26% slowing on CDR-SBBiomarker response: Diranersen is the first tau-directed therapy to demonstrate robust reductions in both CSF total tau, with mean reductions of 50–65%, and brain tau pathology, as measured by PET, across all studied doses in a Phase 2 studyDose response: CDR-SB results favored diranersen versus placebo across all studied doses; higher doses were not associated with greater slowing of declineMechanism of action: Distinct from other tau-lowering approaches, diranersen targets MAPT mRNA to reduce the production of all tau isoforms, lowering both intracellular and extracellular tau protein CAMBRIDGE, Mass., July 14, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced data from the Phase 2 CELIA study evaluating diranersen, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease. The data, presented at the Alzheimer’s Association International Conference (AAIC) 2026, expand upon previously reported topline results and demonstrate a combination of meaningful clinical efficacy and robust biomarker effects, providing Phase 2 proof of concept for diranersen’s tau-directed mechanism of action. Based on the growing and consistent body of evidence from the Phase 1b and Phase 2 studies, Biogen plans to advance diranersen into confirmatory Phase 3 development.1

“The CELIA data provide some of the clearest evidence that reducing tau pathology can translate into clinically meaningful benefit,” said Professor Cath Mummery, Professor of Clinical Neurology at the UCL Queen Square Institute of Neurology and Consultant Neurologist at University College London Hospitals NHS Foundation Trust. “The magnitude of tau reduction and cognitive benefit observed in CELIA is among the most compelling reported to date in Alzheimer’s disease drug development and supports advancing diranersen to Phase 3 development.”

“The CELIA clinical, biomarker, and safety data presented at AAIC provide proof of concept and important evidence of diranersen’s novel tau-reduction mechanism of action translating into clinical benefit. If confirmed in Phase 3, diranersen could represent an important new therapeutic approach targeting one of the core pathologies of Alzheimer's disease,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “Patients and families urgently need new approaches that address the complexity of Alzheimer’s disease. We look forward to working with health authorities and the broader Alzheimer’s community as diranersen advances to Phase 3.”

Diranersen demonstrated efficacy across all studied doses at 18 months, with consistent efficacy across multiple prespecified secondary endpoints, including the Clinical Dementia Rating Sum of Boxes (CDR-SB), a global measure of cognition and daily function; ADAS-Cog13 and MMSE, measures of cognition; modified iADRS and ADCOMS, composite measures of cognition, function, and disease progression; as well as the individual cognitive and functional domains of CDR-SB. Diranersen 60 mg administered intrathecally every six months (n=60) showed the strongest response at 18 months. Compared with placebo (n=115), diranersen 60 mg demonstrated slowing of clinical decline by 0.54 points (26%) on CDR-SB; 42% on ADAS-Cog13; 50% on MMSE; 30% on modified iADRS; and 23% on ADCOMS. The majority of these endpoint differences achieved nominal statistical significance compared with placebo.

Clinical effects were also observed in the other studied dose regimens. Compared with placebo, diranersen 115 mg administered intrathecally every six months (n=115) and diranersen 115 mg administered intrathecally every three months (n=116) demonstrated slowing of clinical decline by 0.28 and 0.18 points (14% and 9%) on CDR-SB; 32% and 29% on ADAS-Cog13; 34% and 38% on MMSE; 29% and 18% on modified iADRS; and 21% and 7% on ADCOMS, respectively. At 18 months, no separation from placebo was observed across dose groups on ADCS-ADL-MCI, a measure of daily functioning, and longer-term follow-up continues to assess whether a longer duration of diranersen therapy impacts this endpoint. Of note, while ADCS-ADL-MCI results were inconsistent across dose regimens, slowing of functional decline based on the functional domains of CDR-SB favored diranersen across all studied doses.  

CELIA was designed with a primary endpoint of dose response on CDR-SB at 18 months to investigate whether higher doses of diranersen could provide greater clinical benefit. As previously disclosed, this was not observed, and the study did not meet its primary endpoint.

Diranersen demonstrated target engagement and robust reductions in cerebrospinal fluid (CSF) total tau across all studied doses, with mean reductions of 50–65% from baseline. In the tau PET imaging substudy (n=131), decreases from baseline were seen across all evaluated brain regions for all diranersen doses. Diranersen is the first tau-directed therapy to demonstrate reductions in both CSF total tau and brain tau pathology, as measured by PET, across all studied doses in a Phase 2 study.

Diranersen was generally well tolerated. During the placebo-controlled period, most participants who experienced adverse events had events that were mild or moderate in severity, non-serious, and did not result in treatment discontinuation or study withdrawal. The most frequent adverse events were procedural pain, post-lumbar puncture syndrome, and confusional state. Most adverse events of confusional state occurred within a few days of dosing and resolved within a week. Among participants who completed the placebo-controlled period, more than 90% elected to continue into the extension study. Amyloid-related imaging abnormalities (ARIA) are not anticipated with diranersen based on its tau-targeting mechanism of action, and the results from CELIA are consistent with that expectation.

The study enrolled a population representative of early Alzheimer’s disease, with baseline characteristics generally balanced across treatment groups. Participants had a mean age of 68 years, 51% were female, and 60% were classified as having mild cognitive impairment, with 40% having mild Alzheimer’s disease dementia. ApoE4 carriers represented approximately 69% of participants, including 23% homozygotes.

Additional analyses and data from CELIA and the ongoing long-term extension study will be presented at future scientific conferences.

A Media Snippet accompanying this announcement is available by clicking on this link.

Educational Program on Tau in Alzheimer’s Disease
At AAIC, Biogen is hosting an interactive booth offering an immersive journey into the role of tau in Alzheimer’s disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on KnowTau.com, building on the resources already available.

For more information, please see the AAIC 2026 program and visit the Biogen AAIC booth.

About diranersen (BIIB080)
Diranersen (BIIB080) is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Unlike many investigational approaches that have focused on targeting extracellular tau, diranersen is designed to reduce both intracellular and extracellular tau.

Diranersen is being investigated as a potential treatment for early Alzheimer’s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of Alzheimer’s disease.

In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize diranersen. Diranersen was discovered by Ionis.   

About the CELIA Study
CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety, and tolerability of diranersen in individuals with early Alzheimer’s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy.

The study evaluated three doses of diranersen administered intrathecally over an 18-month placebo-controlled treatment period: 60 mg every six months, 115 mg every six months, and 115 mg every three months.

The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker, and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). Additional information on the study design is available in the ClinicalTrials.gov listing for the CELIA study.

An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability, and durability of diranersen’s clinical benefit in early Alzheimer’s disease.

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, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This news release contains forward-looking statements, including, among others, relating to: the potential benefits, efficacy and safety of diranersen; the potential that, if confirmed in Phase 3, diranersen could represent a new therapeutic approach targeting one of the core pathologies of Alzheimer's disease; potential regulatory discussions, submissions, decisions and approvals and the timing thereof; the anticipated benefits, risks and potential of our collaboration arrangements; the potential of our commercial business and pipeline programs, including diranersen; 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 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 this social media channel in addition to our press releases, SEC filings, public conference calls and webcasts, as the information posted on them could be material to investors. 

Reference:

Shulman M, Wu S, Ziogas N, et al. Exploratory analyses of clinical outcomes from the BIIB080 phase 1b study in mild Alzheimer’s disease. Nature Aging. 2026;6:445-453. https://doi.org/10.1038/s43587-025-01031-9. Accessed July 2026.

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that its partner, Biogen, shared data from the Phase 2 CELIA study evaluating diranersen, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer's disease. The data, presented at the Alzheimer's Association International Conference (AAIC) 2026, expand upon previously reported topline results and demonstrate a combination of meaningful clinical effi.

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 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-disease

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 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 Dosing

The 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 Pathway

The 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 partners Reduce reliance on infusion and associated healthcare resources Decrease treatment preparation and administration time, and nursing monitoring requirements Preserve infusion capacity for patients who prefer or require intravenous therapy Insights 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 INFORMATION

WARNING: 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 ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 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 ε4 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 ε4 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 ε4 Carrier Status
Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 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 ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 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 ε4 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 ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 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 REACTIONS

The 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/mL Subcutaneous injection: 200 mg/mL Please 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 Department

TEL: +81 (0)3-3817-5120

Eisai Europe, Ltd.

EMEA Communications Department

+44 (0) 7760 619251

[email protected]

Eisai Inc. (U.S.)

Libby Holman

+1-201-753-1945

[email protected] 

Biogen Inc.

Madeleine Shin

+1-781-464-3260

[email protected]

INVESTOR CONTACTS

Eisai Co., Ltd.

Investor Relations Department

TEL: +81 (0) 3-3817-5122

Biogen Inc.

Tim Power

+ 1-781-464-2442

[email protected]

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 (Aβ).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<0.00001).* Additionally, LEQEMBI continued to show benefit over a four-year LTE treatment period; in a subgroup analysis, 81 percent of LEQEMBI patients who stayed on treatment remained in the early AD stages at four years.**

Over three years of treatment, including both the core study and the LTE, 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-year mark. In Clarity AD, the most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

*The Centiloid scale is used for amyloid PET, where 0 CL is anchored as the average amyloid in young people without amyloid plaques, and 100 is anchored as the average amyloid level in moderate AD.  The baseline centiloid level in CLARITY AD was approximately 78 CL. Plaque negativity is defined as conversion to amyloid PET negative (<30 centiloid, or CL).
**Prespecified subgroup analysis of reduced risk of progression: Progression was defined as CDR-SB score progressing to moderate or severe dementia (≥9.5), based on Kaplan-Meier plots.

About Protofibrils
Protofibrils are thought to be the most toxic Aβ 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.18The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ 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.2 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.

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, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. 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.

References

Amin L, Harris DA. Aβ 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-β 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. SOURCE Eisai Inc.

As of 11:45 a.m. ET, the S&P 500 (^GSPC 0.79%) fell 0.39% to 7,546.18, the Nasdaq Composite (^IXIC 1.48%) slid 0.92% to 26,039.24 on tech weakness, and the Dow Jones Industrial Average (^DJI 0.30%) dipped 0.21% to 52,528.23, somewhat cushioned by energy names.

Market moversA sharp rise in oil prices aided energy-linked Dow components while semiconductor names stayed under pressure after steep declines in SK Hynix (SKHY 7.75%) and Samsung Electronics; pockets of resilience appeared in select large-cap tech like Apple (AAPL +0.37%) and biotech name Biogen (BIIB +5.08%) on upbeat analyst calls.

What this means for investorsGeopolitical strife continued to influence stocks as the U.S. and Iran traded words and military strikes. That led global equity markets to take a risk-off stance as oil prices rose about 5%. Tech names in Asia sank overnight, and that continued after U.S. markets opened.

South Korean semiconductor maker SK Hynix reversed course after its strong U.S. market debut on Friday. Samsung also sank even after reporting record profits with a 19-fold year-on-year jump late last week.

The U.S.-Iran conflict continues to take center stage, souring risk sentiment and driving investors toward energy names and away from tech growth stocks.

Earnings season begins tomorrow as major U.S. banks start to report Q2. Investors will be monitoring that closely, as company results will likely determine whether the first-half rally continues or stalls.

Howard Smith has positions in Apple. The Motley Fool has positions in and recommends Apple. The Motley Fool recommends Biogen. The Motley Fool has a disclosure policy.