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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.

Read Our Latest Stock Report on Biogen

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.

Biogen stock receives a bullish upgrade based on expectations the market will cheer the company's detailed data on its experimental Alzheimer's drug.

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Biogen Inc. (BIIB - Free Report) , which belongs to the Zacks Medical - Biomedical and Genetics industry.

This company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 22.31%.

For the last reported quarter, Biogen came out with earnings of $3.57 per share versus the Zacks Consensus Estimate of $2.95 per share, representing a surprise of 21.02%. For the previous quarter, the company was expected to post earnings of $1.61 per share and it actually produced earnings of $1.99 per share, delivering a surprise of 23.60%.

Price and EPS Surprise

For Biogen, estimates have been trending higher, thanks in part to this earnings surprise history. And when you look at the stock's positive Zacks Earnings ESP (Expected Surprise Prediction), it's a great indicator of a future earnings beat, especially when combined with its solid Zacks Rank.

Our research shows that stocks with the combination of a positive Earnings ESP and a Zacks Rank #3 (Hold) or better produce a positive surprise nearly 70% of the time. In other words, if you have 10 stocks with this combination, the number of stocks that beat the consensus estimate could be as high as seven.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a version of the Zacks Consensus whose definition is related to change. 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.

Biogen has an Earnings ESP of +0.22% at the moment, suggesting that analysts have grown bullish on its near-term earnings potential. When you combine this positive Earnings ESP with the stock's Zacks Rank #3 (Hold), it shows that another beat is possibly around the corner. The company's next earnings report is expected to be released on July 29, 2026.

When the Earnings ESP comes up negative, investors should note that this will reduce the predictive power of the metric. But, a negative value is not indicative of a stock's earnings miss.

Many companies end up beating the consensus EPS estimate, though this is not the only reason why their shares gain. Additionally, some stocks may remain stable even if they end up missing the consensus estimate.

Because of this, it's really important to check a company's Earnings ESP ahead of its quarterly release to increase the odds of success. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

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BOSTON, June 29, 2026 (GLOBE NEWSWIRE) -- Block & Leviton LLP announces that the United States District Court for the District of Massachusetts has approved the following announcement of a proposed class action settlement that would benefit purchasers of common stock of Biogen, Inc. (NASDAQ: BIIB):

 
OKLAHOMA FIREFIGHTERS PENSION AND 
RETIREMENT SYSTEM,                                                       Plaintiff,

                              v.

BIOGEN INC., MICHEL VOUNATSOS, AND 
ALISHA ALAIMO,

                                                    Defendants.

Case No. 22-cv-10200-WGY

CLASS ACTION

SUMMARY NOTICE OF PROPOSED
SETTLEMENT OF CLASS ACTION

TO:ALL PURCHASERS AND ACQUIRERS OF BIOGEN INC. COMMON STOCK BETWEEN JUNE 8, 2021 AND JULY 12, 2021, INCLUSIVE
A Federal Court has authorized this notice. This is not a solicitation from a lawyer.

Please read this notice carefully. An $18.9 million settlement has been reached for investors in Biogen Inc. common stock between June 8, 2021 and July 12, 2021.

if you are a member of the Class, your legal rights will be affected whether you act or not.

Notice of Settlement: You are hereby notified that a hearing will be held on September 29, 2026, at 2:00 p.m., before the Honorable William G. Young, at the United States District Court, District of Massachusetts, John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Boston, MA 02210, Courtroom 18 – 5th Floor, to determine whether:

(1) the proposed settlement (the “Settlement”) of the above-captioned Action as set forth in the Stipulation and Agreement of Class Action Settlement, dated June 5, 2026 (“Stipulation”) for $18.9 million in cash should be approved by the Court as fair, reasonable, and adequate;

(2) the Judgment as provided under the Stipulation should be entered dismissing the Action with prejudice;

(3) to award Lead Counsel attorneys’ fees and expenses out of the Settlement Fund (as defined in the Notice of Proposed Settlement of Class Action (“Notice”), which is discussed below) and, if so, in what amounts;

(4) to award Lead Plaintiff expenses pursuant to 15 U.S.C. §78u-4(a)(4) in relation to their representation of the Class out of the Settlement Fund and, if so, in what amount; and

(5) the Plan of Allocation should be approved by the Court as fair, reasonable, and adequate.

It is possible that the Court may decide to change the date and/or time of the Settlement Hearing, conduct the Settlement Hearing by video or telephonic video conference, or otherwise allow Class Members to appear at the hearing by telephone or video conference, without further written notice to the Class. To determine whether the date and time of the Settlement Hearing have changed, or whether Class Members must or may participate by telephone or video, it is important that you monitor the Court’s docket and the website, www.BiogenSecuritiesLitigation.com, for any update before making any plans to attend the Settlement Hearing.

IF YOU PURCHASED OR ACQUIRED BIOGEN INC. (“BIOGEN”) COMMON STOCK BETWEEN JUNE 8, 2021 AND JULY 12, 2021, INCLUSIVE, YOUR RIGHTS MAY BE AFFECTED BY THE SETTLEMENT OF THIS LITIGATION

Proof of Claim: To share in the distribution of the Net Settlement Fund, you must establish your rights by submitting a Proof of Claim and Release form (“Proof of Claim”) by mail (postmarked no later than September 24, 2026) or electronically via the website (no later than 11:59 ET on September 24, 2026). Failure to submit your Proof of Claim by September 24, 2026 will subject your claim to rejection and preclude you from receiving any of the recovery in connection with the Settlement of this Action.

If you purchased or acquired Biogen common stock during the period between June 8, 2021 and July 12, 2021, inclusive, and do not request exclusion from the Class, you will be bound by the Settlement and any judgment and release entered in this Action, including, but not limited to, the Judgment, whether or not you submit a Proof of Claim.

Notice: The Notice, which more completely describes the Settlement and your rights thereunder (including your right to object to the Settlement), the Proof of Claim, the Stipulation (which, among other things, contains definitions for the defined terms used in this Summary Notice), and other important documents, may be accessed online at www.BiogenSecuritiesLitigation.com, or by writing to or calling:

Biogen Securities Litigation Settlement
c/o Strategic Claims Services
P.O. Box 230
600 N. Jackson St., Ste. 205
Media, PA 19063
1-866-274-4004

Inquiries should NOT be directed to Defendants, the Court, or the Clerk of the Court. Inquiries other than requests for the Notice or for a Proof of Claim may be made to Lead Counsel:

Block & Leviton LLP
Michael D. Gaines
260 Franklin Street, Suite 1860
Boston, MA 02110
(617) 398-5600
[email protected]

Exclusion: If you desire to be excluded from the Class, you must submit a request for exclusion such that it is received by August 25, 2026, in the manner and form explained in the Notice. All Class members will be bound by the Settlement even if they do not submit a timely Proof of Claim.

Objections: If you are a Class member, you have the right to object to the Settlement, the Plan of Allocation, the request by Lead Counsel for an award of attorneys’ fees, and/or the request for an award to Lead Plaintiff in connection with its representation of the Class. Any objections must be filed with the Court and sent to Lead Counsel and Defendants’ counsel such that they are received by September 8, 2026, in the manner and form explained in the Notice available at www.BiogenSecuritiesLitigation.com.

June 16, 2026By Order of the Court
United States District Court, District of Massachusetts

Diranersen presentation will feature Phase 2 CELIA data in early Alzheimer’s disease, including clinical, biomarker and safety results for Biogen’s investigational tau-targeting ASO, following topline results announced in May 2026Lecanemab presentations will highlight emerging data on subcutaneous administration and real-world use, including practical treatment considerations, at-home administration, three-year LEADER data, maintenance dosing and patient experienceAdvances across Biogen’s Alzheimer’s disease portfolio underscore its leadership and continued commitment to innovation in Alzheimer’s care, spanning treatment delivery, real-world evidence and approaches targeting core pathologies, including amyloid and tau
CAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced it will present new data across its Alzheimer’s disease portfolio at the Alzheimer’s Association International Conference (AAIC) 2026, taking place July 12-15 in London, UK. Presentations will include data from the Phase 2 CELIA study evaluating diranersen, an investigational tau-targeting antisense oligonucleotide (ASO), and new analyses from studies of LEQEMBI® (lecanemab).

“Biogen remains committed to advancing innovation across Alzheimer’s care, from treatment delivery and real-world evidence generation to continued progress in addressing core pathologies, including amyloid and tau. Tau has long remained one of the most important targets in Alzheimer’s disease, and the Phase 2 CELIA topline results for diranersen reinforce the potential of tau reduction as a therapeutic approach in early Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “We look forward to presenting initial data from this pioneering study as well as new data on lecanemab on the global stage at AAIC.”

Featured Scientific Sessions and Presentations

Diranersen
Diranersen is an investigational ASO that targets MAPT RNA to reduce tau production at its source, a differentiated approach to addressing abnormal tau both inside and outside neurons. At AAIC, Biogen will present clinical, biomarker and safety data that build on the May 2026 topline announcement and further characterize diranersen as the program advances toward Phase 3 development.

Topline Results from CELIA: A Phase 2 Study to Evaluate the Tau-Targeting ASO Diranersen (BIIB080) in Patients with Early Alzheimer’s Disease
Developing Topics Session: Developing Topics in Phase 2 Clinical Trials,
Tuesday, July 14, 2:00–3:30 PM BST This presentation will feature data from CELIA, an 18-month Phase 2 study evaluating diranersen, Biogen’s investigational tau-targeting ASO, in patients with early Alzheimer’s disease. The presentation will include initial clinical, biomarker and safety results from the study.

Lecanemab
Featured lecanemab sessions at AAIC will highlight continued progress in the treatment landscape for early Alzheimer’s disease, with data spanning subcutaneous administration, including at-home use, practical treatment considerations, and three-year real-world evidence from the multicenter LEADER study.

Developing Topics Session: Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations
Sunday, July 12, 4:15–5:45 PM BST This session will feature presentations on the emerging clinical evidence, safety profile, practical use considerations and real-world patient experience with subcutaneous lecanemab administration in early Alzheimer’s disease.

Featured Research Session: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse U.S. Clinical Settings
Tuesday, July 14, 4:15–5:45 PM BST This session will feature new real-world evidence from the LEADER study, including findings on lecanemab use and outcomes across diverse U.S. clinical settings, once-monthly maintenance dosing, patient pathways and physician and perceived patient satisfaction with maintenance therapy.

Selected Additional Oral and Poster Presentations
The following selected presentations highlight additional areas of Alzheimer’s disease research being presented at AAIC, including lecanemab-related data. For a complete list of presentations, please refer to the AAIC scientific program.

Real-world Insights into Clinician Involvement and Testing Approaches for Mild Cognitive Impairment and Alzheimer’s
Monday, July 13, 7:30 AM–4:15 PM BST Continued or Time-limited Treatment Benefits of Anti-amyloid Monoclonal Antibodies in Early Alzheimer’s Disease
Monday, July 13, 7:30 AM–4:15 PM BST
Lecanemab Treatment for Alzheimer’s Disease in Real-World Clinical Practice: A Multicenter, Surveillance Safety Study from the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) Registry
Tuesday, July 14, 9:00–10:30 AM BST
Impact of Biomarker Modalities in the Diagnostic Evaluation of Patients with Suspected Alzheimer’s Disease: A US Retrospective Study
Wednesday, July 15, 7:30 AM–4:15 PM BST Estimating the Economic Impact of Delayed Alzheimer’s Disease Progression with Lecanemab
Wednesday, July 15, 7:30 AM–4:15 PM BST Educational Program on Tau in Alzheimer’s Disease
At AAIC, Biogen will host 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 CELIA 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 in early Alzheimer’s disease.

About LEQEMBI ® (lecanemab)
LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble protofibril and insoluble forms of amyloid beta (Aβ). LEQEMBI is indicated in the U.S. for the treatment of Alzheimer’s disease and treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. 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 treatment phase with intravenous dosing every two weeks for 18 months, intravenous maintenance dosing every four weeks has been approved in 7 countries, including the U.S., China and the UK, with applications filed in additional countries and regions. In the U.S., FDA approved LEQEMBI IQLIK™ for once-weekly subcutaneous maintenance dosing in August 2025. A supplemental Biologics License Application for LEQEMBI IQLIK as a once-weekly subcutaneous starting dose is currently under FDA Priority Review, with a Prescription Drug User Fee Act action date of August 24, 2026.

Eisai and Biogen have been collaborating on the joint development and commercialization of Alzheimer’s disease treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide.

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 (BIIB080) and lecanemab (LEQEMBI); the potential to advance care and improve outcomes for, and address unmet needs of, patients with 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 Biogen’s Alzheimer’s disease portfolio; 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.

, /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. ("Biogen" or the "Company") (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.

The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action]

On May 14, 2026, Biogen issued a press release announcing "topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer's disease."  Although Biogen described the results as "compelling," the study missed its primary dose-response endpoint. 

On this news, Biogen's stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Danielle Peyton
Pomerantz LLP
[email protected]
646-581-9980 ext. 7980

SOURCE Pomerantz LLP

By Reuters

June 17, 202611:10 PM UTCUpdated June 18, 2026

Biogen logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration/File Photo Purchase Licensing Rights, opens new tab

CompaniesJune 17 (Reuters) - Biogen (BIIB.O), opens new tab has struck a deal to acquire ​private biotechnology company RayThera for ‌up to $1 billion, the companies said on Wednesday, as the U.S.-listed ​drugmaker seeks to expand ​its pipeline in immunology.

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The transaction will ⁠include an upfront payment ​to RayThera shareholders, along with ​additional payments tied to clinical and regulatory milestones, the companies said in a ​statement.

San Diego-based RayThera's portfolio ​includes several anti-inflammatory drug candidates, with its ‌lead ⁠program expected to enter Phase 1 clinical trials in early third quarter, 2026.

The deal comes ​at a ​time ⁠of biotech dealmaking frenzy, with large drugmakers on a ​spending spree to expand ​their ⁠product pipelines this year.

In March, Biogen acquired Apellis Pharmaceuticals for about $5.6 ⁠billion, ​expanding its presence ​in kidney disease treatments.

Reporting by Ananya Palyekar ​in Bengaluru; Editing by Joyjeet Das

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

Key Takeaways BIIB agreed to acquire RayThera for up to $1B, with milestone-based payments included.RayThera adds anti-inflammatory candidates, including a lead asset entering phase I in Q3 2026.BIIB's RayThera acquisition is expected to be closed in the third quarter of 2026. Biogen (BIIB - Free Report) announced that it has entered into a definitive agreement to acquire San Diego-based privately held biotech RayThera Inc. for up to $1 billion. The deal includes an undisclosed upfront payment to RayThera's shareholders and additional payments tied to the achievement of certain clinical and regulatory milestones.

The transaction is expected to be closed in the third quarter of 2026, subject to customary closing conditions.

Biogen's proposed acquisition of RayThera will add several anti-inflammatory candidates to its pipeline, including a lead asset that is expected to enter phase I development in early third quarter 2026. These candidates are being developed as potential treatments for immune-mediated diseases across multiple indications.

BIIB’s Price PerformanceYear to date, shares of Biogen have rallied 12.9% against the industry’s decline of 0.9%.

Image Source: Zacks Investment Research

BIIB’s Recent Acquisition DealThe acquisition of RayThera is expected to strengthen BIIB’s immunology pipeline by adding a portfolio of anti-inflammatory candidates.

The latest deal comes on the heels of Biogen’s recent acquisition of Apellis, which added two differentiated commercialized immunology medicines, Empaveli (pegcetacoplan) and Syfovre (pegcetacoplan injection), to its commercial portfolio.

Such acquisitions highlight the continued interest among large drugmakers in bolstering their pipelines through targeted acquisitions of promising clinical-stage biotechnology companies.

Biotech, Pharma on a M&A SpreeThe biotech and pharma sector is seeing strong merger and acquisition (M&A) activity in 2026, with deals accelerating in recent times.

The recent surge in dealmaking underscores the industry’s broader focus on portfolio expansion and continuous pipeline innovation, alongside a growing emphasis on AI-driven drug discovery. Oncology and immuno-oncology companies have always been at the top of acquisition targets.

So far in 2026, Eli Lilly (LLY - Free Report) has announced six proposed acquisitions — Centessa Pharmaceuticals, Ajax Therapeutics, Kelonia Therapeutics, Orna Therapeutics, CrossBridge Bio and Ventyx Biosciences — to diversify beyond its GLP-1 franchise and strengthen its pipeline in oncology, neuroscience, RNA and cell therapies.

LLY also agreed to acquire three private vaccine developers in May 2026, adding programs targeting shingles, bacterial infections and Epstein-Barr virus. The company also announced several M&A deals in 2025.

Earlier this month, GSK plc (GSK - Free Report) announced that it will acquire clinical-stage biopharmaceutical company Nuvalent for $10.6 billion, gaining three lung cancer assets, including late-stage ROS1 inhibitor zidesamtinib and ALK inhibitor neladalkib, both under FDA review.

The deal strengthens GSK’s oncology pipeline, expands its presence in lung cancer, and is expected to contribute to sales and operating profit growth beginning in 2027.

GSK earlier acquired RAPT Therapeutics to strengthen its immunology pipeline. The company also bought 35Pharma, adding HS235, a potential best-in-class therapy for pulmonary hypertension.

Merck (MRK - Free Report) recently completed the acquisition of California-based cancer biotech, Terns Pharmaceuticals. The acquisition added TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor, to Merck’s hematology/cancer pipeline.

Merck acquired Verona Pharma in 2025 and Cidara Therapeutics in early 2026, which likely strengthened its respiratory and infectious disease portfolios.

Several large pharmaceutical companies, including Novartis, Gilead Sciences and Johnson & Johnson, have been actively pursuing targeted acquisitions of clinical-stage biotech firms to strengthen their pipelines and drive long-term growth.

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.

NEW YORK, June 23, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.

The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action]

On May 14, 2026, Biogen issued a press release announcing “topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease.”  Although Biogen described the results as “compelling,” the study missed its primary dose-response endpoint. 

On this news, Biogen’s stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Danielle Peyton
Pomerantz LLP
[email protected]
646-581-9980 ext. 7980

NEW YORK, May 29, 2026 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Biogen Inc.:

Due to the forgoing, The Gross Law Firm is investigating potential securities fraud claims on behalf of certain Biogen Inc. investors. If you incurred a loss on your BIIB investment, please contact us using the link below to discuss your rights.

https://securitiesclasslaw.com/securities/biogen-inc-loss-submission-form-3/?id=187164&from=3 

WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
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Email: [email protected] 
Phone: (646) 453-8903

It has been about a month since the last earnings report for Biogen Inc. (BIIB - Free Report) . Shares have added about 3.8% in that time frame, underperforming the S&P 500.

Will the recent positive trend continue leading up to its next earnings release, or is Biogen due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts.

Q1 Earnings & Sales BeatBiogen reported first-quarter 2026 adjusted earnings per share (EPS) of $3.57, which significantly beat the Zacks Consensus Estimate of $2.95. Earnings rose 18% year over year. The adjusted EPS reflected approximately 20 cents per share impact of IPR&D charges, related primarily to Alteogen and Alloy transactions.

Total revenues during the quarter came in at $2.48 billion, up 2% year over year on a reported basis. However, revenues declined 2% on a constant-currency basis. Revenues beat the Zacks Consensus Estimate of $2.25 billion.

Lower sales of key Tecfidera and Spinraza were partially offset by higher revenues from new drugs, 
Skyclarys, Qalsody and Zurzuvae. Improved inventory dynamics also benefited sales of MS drugs like Tysabri and Vumerity in the quarter.

Biogen’s growth products (Skyclarys, Qalsody, Zurzuvae, Vumerity and Spinraza Alzheimer’s revenues form Leqembi collaboration) generated sales of $851 million in the first quarter, rising 12% year over year.

Product sales in the quarter were $1.75 billion, down 3% year over year on a constant currency basis.

Revenues from anti-CD20 therapeutic programs rose 11% to $419 million.

Contract manufacturing and royalty revenues declined 20% year over year to $247.0 million. Alzheimer’s collaboration revenues were $60 million, up 80% year over year.

Alzheimer’s collaboration revenues include Biogen’s 50% share of net product revenues and cost of sales (including royalties) from Leqembi. Eisai recorded nearly $168 million in global revenues from Leqembi sales in the first quarter, up 74% year over year and 25% sequentially, driven by demand growth globally. The drug’s U.S. sales rose 10.3% quarter over quarter to $86 million.

Multiple Sclerosis RevenuesMS revenues totaled $958 million, down 3% on a constant-currency basis, due to generic competition for Tecfidera globally and Tysabri in Europe and rising competitive pressure in the MS market.

Tecfidera sales declined 47% to around $109.5 million due to generic erosion globally, particularly in Europe. The drug’s sales also missed the Zacks Consensus Estimate of $111 million.

Vumerity recorded $179 million in sales, up around 29% year over year, driven by strong demand and improved inventory dynamics in the United States. This metric beat the Zacks Consensus Estimate of $164 million.

Tysabri sales rose 15.7% year over year to $441.5 million as the impact of biosimilar competition in Europe and a decrease in U.S. demand were offset by favorable adjustments to discounts and allowances and the favorable impact of inventory timing. The drug’s sales beat the Zacks Consensus Estimate of $359 million.

Combined interferon revenues (Avonex and Plegridy) were almost flat year over year at about $227.5 million.

In 2026, Biogen expects revenues for MS products, excluding Vumerity, to decline by a mid-teen percentage versus 2025.

Rare Disease DrugsSales of Spinraza declined around 12% to $374 million. The figure missed the Zacks Consensus Estimate of $379 million

Spinraza’s U.S. sales declined 8% year over year to $142.2 million due to lower demand and unfavorable inventory dynamics. In the rest of the world, Spinraza sales declined 14% to $231.8 million due to unfavorable timing of shipments.

Skyclarys generated sales of $150.7 million, up 21.6% year over year, driven by continued demand growth. In the United States, revenues of $71.8 million rose 4% year over year. However, on a sequential basis, Skyclarys’ U.S. sales declined 19.2% due to unfavorable inventory dynamics, which offset the positive impact of moderate demand growth. In ex-U.S. markets, sales rose 44% to $78.9 million, driven by strong adoption trends.

Qalsody added sales of $32.5 million, up more than 100% year over year, driven by demand growth.

In 2026, Biogen expects Rare Disease revenues to grow due to the continued launch of Skyclarys in the EU and other ex-U.S. markets and the continued launch of Qalsody in Europe. Biogen expects global Spinraza revenues to be relatively flat in 2026.

Other ProductsNew drug Zurzuvae (for postpartum depression) recorded sales of nearly $55.4 million in the quarter, down 16% on a sequential basis as demand growth was partially offset by inventory dynamics.

Biosimilar revenues declined 7% year over year to $182 million during the quarter.

Costs DeclineAdjusted research and development (R&D) expenses rose 13% year over year to $480 million due to increased costs behind the company’s late-stage candidates like litifilimab and felzartamab.

Adjusted selling, general and administrative (SG&A) expenses rose 5% to $600 million due to higher costs to support the new product launches.

In the quarter, the collaboration profit-sharing was a net expense of around $74 million, which included nearly $57 million of net profit-sharing expenses related to Biogen’s biosimilar collaboration with Samsung Bioepis and around $17 million of net profit-sharing expenses linked to Biogen’s collaboration with Supernus Pharmaceuticals for marketing Zurzuvae in the United States.

Maintains 2026 GuidanceBiogen maintained its revenue guidance for the year while lowering its earnings guidance to include IPR&D charges related to M&A activities.

Total revenues are expected to decline by a mid-single-digit percentage in constant currency terms in 2026 from the 2025 level. A decline in MS revenues (excluding Vumerity) is expected to be partially offset by higher revenues from growth products.

Adjusted EPS guidance was lowered from a range of $15.25 to $16.25 to $14.25 to $15.25 to include an IPR&D charge of $1.00 per share. The charge comprised approximately 20 cents recorded in the first quarter and approximately 80 cents expected to be recorded in the second quarter (mainly for the TJ Bio transaction for felzartamab rights in China) but does not include any costs related to the Apellis transaction.

Biogen expects Apellis to be accretive to earnings in 2027 and the acquisition to boost Biogen’s adjusted EPS growth rate over the remainder of the decade.

The gross margin in 2026 is expected to be similar to the 2025 levels. Combined adjusted R&D and SG&A costs are also expected to be similar to 2025 levels.

In the second quarter, Biogen expects core operating expenses to be roughly consistent with the first quarter.

How Have Estimates Been Moving Since Then?Since the earnings release, investors have witnessed a downward trend in estimates revision.

The consensus estimate has shifted -20.37% due to these changes.

VGM ScoresAt this time, Biogen has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. However, the stock has a grade of B on the value side, putting it in the second quintile for this investment strategy.

Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Biogen has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.

NEW YORK, June 02, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or the “Company”) (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.

The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

[Click here for information about joining the class action]

On May 14, 2026, Biogen issued a press release announcing “topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer’s disease.” Although Biogen described the results as “compelling,” the study missed its primary dose-response endpoint.

On this news, Biogen’s stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Danielle Peyton
Pomerantz LLP
[email protected]
646-581-9980 ext. 7980

Steroid use reduction and disease control: In additional results from the Phase 3 PHOENYCS GO study, dapirolizumab pegol (DZP) plus standard of care was associated with sustained disease control at lower glucocorticoid doses through Week 48 compared with placebo plus standard of care, supporting reduced long-term steroid exposureReduced flare rates and immune marker improvements: In other findings presented at EULAR 2026, improvements in immunological markers and reduced flare rates were observed, supporting the potential of dapirolizumab pegol to address the complex burden of SLE BRUSSELS, Belgium and CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (Nasdaq: BIIB) today announced data, comprising two posters and three abstracts, at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, demonstrating the clinical profile of dapirolizumab pegol (DZP), an investigational biologic in patients with systemic lupus erythematosus (SLE).

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple organs, including skin, joints and kidneys, often requiring long-term treatment to control disease activity.1 Patients with SLE frequently experience flares, transient worsening of disease activity that can lead to permanent organ damage, increased morbidity, and even early mortality.2 Many patients rely on steroid-based therapy to manage flares; however, prolonged steroid use is associated with significant cumulative toxicity, making steroid tapering while maintaining disease control a key goal in SLE management.3,4

“Achieving and maintaining durable disease control while reducing glucocorticoid exposure is one of the central challenges in managing SLE,” said Megan E. B. Clowse, M.D., MPH, Chief of the Division of Rheumatology and Immunology, Duke University, and primary author of the PHOENYCS GO primary results. “The Phase 3 PHOENYCS GO data showed patients receiving dapirolizumab pegol were more likely to maintain disease control while tapering steroids – an important finding given strong evidence that cumulative steroid exposure and uncontrolled disease activity are major drivers of organ damage accrual, morbidity and mortality in SLE.”

Post hoc analyses displayed in one of the posters from the PHOENYCS GO program showed that, in patients with baseline glucocorticoid dose >7.5 mg/day prednisone equivalent, treatment with DZP plus standard of care was associated with a higher proportion of patients achieving control of disease activity while enabling glucocorticoid tapering to ≤7.5 mg/day through Week 48, compared with placebo plus standard of care.5 Importantly, these findings suggest that higher proportions of patients receiving DZP plus standard of care versus placebo plus standard of care achieved sustained glucocorticoid tapering while also achieving BICLA response, achieving SRI-4 response, or remaining free from moderate or severe BILAG-2004 flares through Week 48.5

“At UCB, our mission is to help improve the lives of people living with serious inflammatory diseases by advancing therapies that address unmet needs,” said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs at UCB. “These data showed the potential of dapirolizumab pegol to reduce long-term glucocorticoid use while maintaining disease control, an important goal for people living with SLE and the clinicians who care for them.”

Additional EULAR 2026 presentations highlighted the breadth of data from the PHOENYCS GO program, including:

Improvements in key immunological markers, including reduced anti-dsDNA antibodies and increased complement proteins C3 and C4 in patients with abnormal levels at baseline (Poster POS1364).6Lower rates of moderate or moderate/severe BILAG-2004 flares with DZP plus standard of care versus placebo plus standard of care through Week 48, using alternative definitions of flares to increase measurement sensitivity (Abstract AB1163).7Insights into how symptoms and flares are assessed in SLE, including fatigue as a burdensome patient-reported symptom that can be difficult to capture in clinical trials (Abstracts AB1184 and AB1125).8,9
Together, these findings support the importance of tools that can measure patient experience and help inform more meaningful assessment of disease impact in both clinical practice and research.8,9

“Systemic lupus erythematosus is a biologically complex disease, and these EULAR data further characterize dapirolizumab pegol’s impact across clinical, biological and patient-reported outcomes,” said Diana Gallagher, MD, Head of Immunology, MS and Alzheimer’s Development Units at Biogen. “Delivering this data reflects the strength of the UCB and Biogen collaboration and our shared commitment to advancing evidence that may help address the complex and multifaceted needs of people living with SLE.”

The EULAR data follow the recent publication of the Phase 3 PHOENYCS GO study in The Lancet, reporting clinically meaningful improvements in disease activity with dapirolizumab pegol at Week 48.10 In the Phase 3 PHOENYCS GO study, DZP demonstrated a generally favorable safety profile, with safety findings consistent with previous DZP studies.10,11 Treatment-emergent adverse events were more common with DZP plus standard of care versus placebo plus standard of care, while serious treatment-emergent adverse events were less frequent in the DZP plus standard of care arm, and discontinuations due to treatment-emergent adverse events were low in both groups.10

About Dapirolizumab Pegol
Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment.11 Dapirolizumab pegol inhibits CD40L signaling, which has been shown to reduce B-cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion and attenuate T-cell and antigen-presenting cell (APC) activation.11 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.12,13

Dapirolizumab pegol is an investigational biologic currently in clinical development. The safety and efficacy have not been established, and it is not approved by any health authority worldwide.

About UCB
UCB, Brussels, Belgium (www.ucb.com), is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB).

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.

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.

Forward-looking Statements - UCB
This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document.

Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.

UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Biogen Safe Harbor
This news release contains forward-looking statements, including, among others, relating to: the potential benefits, safety and efficacy of dapirolizumab pegol (DZP); the potential of dapirolizumab pegol to address the needs of people living with systemic lupus erythematosus (SLE), including the potential to help patients maintain disease control while tapering steroids; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with UCB; the potential of Biogen's commercial business and pipeline programs, including dapirolizumab pegol; potential regulatory discussions, submissions and approvals and the timing thereof; and the 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,” 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: 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 presentation and the discussions during this conference call 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:

Pons-Estel GJ, Alarcón GS, Scofield L, et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010;39(4):257-68.Thanou A, Jupe E, Purushothaman M, et al. Clinical disease activity and flare in SLE: current concepts and novel biomarkers. J Autoimmun. 2021;119:102615. doi:10.1016/j.jaut.2021.102615.Palmowski A, Pankow A, Terziyska K, et al. Continuing versus tapering low-dose glucocorticoids in patients with rheumatoid arthritis and systemic lupus erythematosus in states of low disease activity or remission: a systematic review and meta-analysis of randomised trials. Semin Arthritis Rheum. 2024;64:152349. doi:10.1016/j.semarthrit.2023.152349.Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019;78(6):736–45. doi:10.1136/annrheumdis-2019-215089.Morand EF, Bertsias G, Carter LM, et al. Glucocorticoid-sparing maintenance of disease control in patients with systemic lupus erythematosus: 48-week results from a phase 3 trial of dapirolizumab pegol. Ann Rheum Dis. 2026;85(Suppl 1):POS0730.Dörner T, Pisetsky DS, Fava A, et al. Dapirolizumab pegol treatment and improvement in laboratory markers of disease activity in patients with systemic lupus erythematosus: 48-week results from a phase 3 trial. Ann Rheum Dis. 2026;85(Suppl 1):POS1364.Furie RA, Bertsias G, Carter LM, et al. Dapirolizumab pegol and flare reduction in patients with systemic lupus erythematosus in a 48-week phase 3 trial: an updated post hoc analysis of alternative definitions of flares that reflect clinical practice. Ann Rheum Dis. 2026;85(Suppl 1):AB1163.de la Loge C, Touma Z, Gordon C, et al. Measuring fatigue in systemic lupus erythematosus: measurement properties of the FATIGUE-PRO total score using data from a phase 3 trial of dapirolizumab pegol. Ann Rheum Dis. 2026;85(Suppl 1):AB1184.Mosca M, Anjohrin S, Rawlings A, et al. Physicians’ perspectives on recognition of flares in patients with systemic lupus erythematosus in the clinic: real world insights from the United States and Europe. Ann Rheum Dis. 2026;85(Suppl 1):AB1125.Clowse MEB, Isenberg DA, Merrill JT, et al. Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published online May 29, 2026. doi:10.1016/S0140-6736(26)00691-4.Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus (SLE). Rheumatology (Oxford). 2021;60(11): 5397-407.ClinicalTrials.gov. NCT04294667. https://clinicaltrials.gov/study/NCT04294667. Accessed May 29, 2026.ClinicalTrials.gov. NCT06617325. https://clinicaltrials.gov/study/NCT06617325. Accessed May 29, 2026.

, /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Biogen Inc. ("Biogen" or the "Company") (NASDAQ: BIIB). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.

The investigation concerns whether Biogen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action]

On May 14, 2026, Biogen issued a press release announcing "topline results from the Phase 2 CELIA study evaluating diranersen (BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer's disease."  Although Biogen described the results as "compelling," the study missed its primary dose-response endpoint. 

On this news, Biogen's stock price fell $13.16 per share, or 6.43%, to close at $191.37 per share on May 14, 2026.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes. 

CONTACT:

Danielle Peyton

Pomerantz LLP

[email protected] 

646-581-9980 ext. 7980

SOURCE Pomerantz LLP

The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biogen Inc. (“Biogen” or “the Company”) (NASDAQ: BIIB) for violations of the securities laws.

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Biogen revealed on May 14, 2026, that the topline data from its Phase 2 CELIA study for diranersen failed to meet its primary endpoints. Based on these facts, the Company’s shares fell about 6.4% on the same day.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected].

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260604049144/en/