Biogen čeká ve 2. čtvrtletí slabší tržby z léků na RS, ale růst nových produktů Skyclarys, Zurzuvae a příjmů z Alzheimerovy spolupráce by to mohl vyvážit.
Key Takeaways Biogen's new launches may help offset weaker MS franchise sales in second-quarter results due July 29.BIIB may see growth from Skyclarys, Zurzuvae and Alzheimer's collaboration revenues in Q2.Biogen will record acquisition-related IPR&D charges as investors watch Apellis portfolio sales. We expect Biogen (BIIB - Free Report) to beat expectations when it reports second-quarter 2026 results on July 29, before market opens. In the last reported quarter, the company's earnings beat expectations by 21.02%. The Zacks Consensus Estimate for second-quarter sales and earnings is pegged at $2.47 billion and 79 cents per share, respectively.
Factors to Consider for BiogenIn the second quarter, lower sales of Biogen’s multiple sclerosis (“MS”) drugs, excluding Vumerity, are likely to have been offset by sequential revenue growth from new products.
Sales of Biogen’s MS drugs like Tecfidera and Tysabri are likely to have declined due to generic competition for Tecfidera globally, biosimilar competition for Tysabri in Europe and rising competitive pressure in the MS market.
Biogen saw an increased impact of Tecfidera generics in Europe in the last two quarters, with the trend expected to continue in the second quarter.
The Zacks Consensus Estimate for second-quarter sales of Tecfidera is pegged at $103.0 million. The Zacks Consensus Estimate for Tysabri is $375.0 million.
Sales of another MS drug, Vumerity, are expected to have risen due to strong demand in the United States. The Zacks Consensus Estimate for Vumerity is $205.0 million.
Sales of Biogen’s spinal muscular atrophy drug, Spinraza, are likely to have declined due to lower demand in the U.S. market. The Zacks Consensus Estimate for Spinraza is $379.0 million.
The performance of Biogen’s newly launched drug Skyclarys for Friedreich’s ataxia is likely to have continued to improve sequentially, backed by demand growth in outside U.S. markets. The Zacks Consensus Estimate for Skyclarys sales is $155.0 million.
Sales of another new drug, Zurzuvae, are likely to have benefited from strong demand trends.
Biogen has a collaboration with Supernus Pharmaceuticals (SUPN - Free Report) for Zurzuvae. Biogen and Supernus Pharmaceuticals equally share profits and losses for the commercialization of Zurzuvae in the United States. In outside U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea) and pays royalties to Supernus.
Alzheimer’s collaboration revenues are expected to have risen in the quarter. Alzheimer’s collaboration revenues include Biogen’s 50% share of net product revenues and cost of sales (including royalties) from Alzheimer’s drug Leqembi (lecanemab), which has been developed in collaboration with Eisai.
Leqembi sales have been improving sequentially over the past few quarters, driven by demand growth globally. The positive trend is expected to have continued in the second quarter. Eisai records Leqembi sales.
In May, Biogen closed its acquisition of Apellis Pharmaceuticals, adding the commercialized medicines Empaveli and Syfovre for immune-mediated retinal disease and nephrology to its commercial portfolio. Investors will look for sales numbers of these newly added drugs. In June, Biogen announced a definitive agreement to acquire RayThera for $1 billion to strengthen its immunology pipeline.
In the second quarter, Biogen will record IPR&D charges related to the Apellis acquisition and the acquisition of exclusive rights to felzartamab in China from TJ Biopharma, which will hurt its EPS.
In the second quarter, Biogen expects core operating expenses to be roughly consistent with the first quarter.
BIIB’s Earnings Surprise HistoryThe company’s earnings beat estimates in each of the last four quarters. The company has a four-quarter earnings surprise of 26.87%, on average.
Biogen’s stock has risen 14.0% so far this year compared with an increase of 2.2% for the industry.
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What Our Model Says for BIIBOur proven model predicts an earnings beat for Biogen this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat, which is the case here.
Earnings ESP: Biogen’s Earnings ESP is +282.03%. The Zacks Consensus Estimate is pegged at 79 cents per share, while the Most Accurate Estimate is pegged higher at $3.02 per share. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Biogen has a Zacks Rank #3.
Other Stocks to ConsiderHere are two drug/biotech stocks that also have the right combination of elements to beat on earnings this time around:
Regeneron Pharmaceuticals (REGN - Free Report) has an Earnings ESP of +1.22% and a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron stock has declined 15.3% so far this year. REGN beat estimates in each of the last four quarters. The company has a four-quarter earnings surprise of 26.33%, on average. Regeneron is scheduled to report second-quarter results on July 30.
Pfizer (PFE - Free Report) has an Earnings ESP of +2.07% and a Zacks Rank #3 at present.
Shares of Pfizer have risen 3.8% so far this year. Pfizer beat earnings estimates in each of the last four reported quarters, delivering an average earnings surprise of 21.93%. Pfizer is scheduled to report second-quarter results on Aug. 4.
Biogen získal od FDA schválení pro Leqembi Iqlik, týdenní subkutánní startovací dávku pro rané stádium Alzheimerovy choroby. Autoinjektor lze podat za přibližně 15 sekund i doma.
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.
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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.
Studie LEADER ukázala, že u LEQEMBI zůstalo po průměrně 17 měsících léčby stabilních nebo se zlepšilo 82,5 % pacientů s časným stadiem Alzheimerovy choroby. Z toho 75,9 % zůstalo stabilních a 6,6 % se zlepšilo. Bezpečnost byla v souladu se schváleným americkým příbalovým letákem.
Real-World Findings Support Long-Term Benefits of Continuous Treatment with LEQEMBI and Provide Important Insights into Treatment Experience Outside of a Clinical Trial Setting
, /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study show that nearly 83% of early Alzheimer's disease (AD) patients enrolled in the study remained stable (75.9%) or improved (6.6%) while receiving LEQEMBI® therapy over an average of 17 months. The results were consistent across sex, race, ethnicity and APOE genotype. The data was presented during the "Developing Topics Session #3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings" at the Alzheimer's Association International Conference® (AAIC®) 2026 in London and online.
AD is a chronic, progressive disease that requires ongoing treatment. LEQEMBI targets the underlying pathology of the disease and works in two ways throughout treatment - by removing insoluble (plaque) and soluble amyloid beta (protofibrils), helping to slow cognitive decline and loss of daily functioning. Data show continued treatment with LEQEMBI may be able to help keep patients in early AD for longer. Early AD includes mild cognitive impairment (MCI) due to AD and mild AD dementia.
LEADER Study Design
The three-year LEADER Study is a multicenter, retrospective real-world study designed to examine LEQEMBI utilization, treatment persistence, transition to maintenance therapy, safety, cognitive and functional assessments, and healthcare professional (HCP) implementation learnings in diverse U.S. clinical settings for patients with early Alzheimer's disease (AD). The study integrated deidentified chart and electronic medical record (EMR) data from 13 U.S. sites, HCP surveys and HCP interviews. This interim analysis included 432 patients with early AD who received at least seven LEQEMBI infusions as of May 2026.
Patient Characteristics at Baseline
Mean age: 74 years Female Patients: 55.8% Disease Stage at Baseline
Mild cognitive impairment (MCI) due to AD: 63.9% Mild AD dementia: 36.1%. Treatment
The mean duration of LEQEMBI treatment was 520 days. The mean number of LEQEMBI doses was 26. Change in disease stage was defined as: Stable: Patient remaining in the same disease stage (MCI due to AD or mild AD dementia) from baseline throughout the course of LEQEMBI treatment. Improvement: Patient transitioning from mild AD dementia at baseline to MCI due to AD over the course of LEQEMBI treatment. Progression: Patient advancing from MCI at baseline to mild/moderate AD dementia or from mild AD dementia at baseline to moderate AD dementia throughout the course of LEQEMBI treatment. LEADER Study Key Findings
Real-World Evidence Shows Long-Term Benefit with Continuous LEQEMBI Treatment Across Sex, Race, Ethnicity and APOE Genotype
Overall Study Population Findings
Of the 432 participants enrolled in the LEADER Study, disease stage could be evaluated in 427. Among these patients with early Alzheimer's disease, 82.5% remained stable or improved while receiving LEQEMBI, with consistent results across sex, race, ethnicity, and APOE genotype groups. 75.9% remained stable compared with baseline, meaning they remained in the same disease stage throughout treatment. 6.6% improved from baseline, moving from mild AD dementia to MCI due to AD. Nearly 87% of patients chose to remain on LEQEMBI treatment. In analyses by APOE ε4 status, clinician-evaluated stable or improved disease stage was observed in: 81.7% of APOE ε4 heterozygotes (stable: 73.8%; improved: 7.9%) 81.0% of APOE ε4 homozygotes (stable: 75.9%; improved: 5.2%). Maintenance Dosing Population Findings
Of the 432 participants in the LEADER Study, 155 transitioned to once-every-four-weeks intravenous (IV) maintenance treatment, and 14 transitioned to once-weekly subcutaneous (SC) maintenance treatment. Among the 155 participants who transitioned to IV maintenance therapy, nearly 81% remained stable (72.3%) or improved (8.4%). Of the 14 patients who transitioned to SC maintenance treatment, 12 (85.7%) maintained their disease stage. Real-World Safety Consistent with U.S. FDA-Approved Label
Overall safety observations in this real-world study were consistent with the U.S. FDA-approved label.
ARIA (amyloid-related imaging abnormalities)* was observed in 12.3% of patients overall; ARIA-E was observed in 6.3% and ARIA-H in 7.9% and isolated ARIA-H in 6.0%. Most ARIA cases were asymptomatic and mild in radiographic severity. No new ARIA-E events, macrohemorrhages or intracerebral hemorrhages greater than 1 cm were reported during once-every-four-weeks IV maintenance therapy. APOE ε4 status safety observations were consistent with the overall cohort and the U.S. FDA-approved label.
ARIA-E was observed in 5.3% of APOE ε4 noncarriers, 6.1% of APOE ε4 heterozygotes and 10.3% of APOE ε4 homozygotes. ARIA-H was observed in 12.1%, 4.8% and 12.1%, respectively. In APOE ε4 homozygotes, no severe ARIA was reported, and all graded ARIA cases were mild to moderate in radiographic severity. Antithrombotic therapy, including anticoagulants or antiplatelet medications, was used by 106 patients, representing 24.5% of the study population.
Of these, 11 patients were receiving an anticoagulant, either alone or with an antiplatelet medication, and 95 patients were receiving antiplatelet therapy only. Among patients receiving antithrombotic therapy, the incidence of ARIA was not meaningfully different from that observed in patients not receiving antithrombotic therapy. * ARIA refers to amyloid-related imaging abnormalities that can be observed with anti-amyloid beta antibody treatment and includes ARIA-E, which involves edema/effusion, and ARIA-H, which involves hemosiderin deposition, including cerebral microhemorrhage, cerebral macrohemorrhage and superficial siderosis, as observed on brain magnetic resonance imaging (MRI).
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
MEDIA CONTACTS
Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0)3-3817-5120
Eisai Europe, Ltd.
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[email protected]
Eisai Inc. (U.S.)
Julie Edelman
+1-862-213-5915
[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
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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 LEQEMBI IQLIK, the subcutaneous autoinjector formulation of lecanemab, for use as maintenance treatment in August 2025 and as initiation treatment on July 13, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China.
Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.
About Protofibrils
Protofibrils are thought to be the most toxic 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.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.2
Limitations of Real-World Studies
Retrospective real-world studies can be valuable in providing additional information to complement clinical trial data; however, there are potential limitations to consider, including: potential for biases, data completeness and consistency, lack of a control group, interpretation of data due to lack of placebo-controlled arms, and confounding variables, and data inconsistency. Data inconsistency may be mitigated by providing site access to standardized electronic case-report forms.
About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.
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.
Biogen uvedl, že diranersen ve 2. fázi studie CELIA u časné Alzheimerovy choroby zpomalil klinický pokles a snížil tau, zejména v dávce 60 mg. Firma plánuje postup do potvrzující 3. fáze.
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.
Biogen a Ionis Pharmaceuticals uvedly, že jejich lék na Alzheimerovu chorobu zaměřený na tau zpomalil kognitivní pokles o 26 % za 18 měsíců. Výsledek se téměř vyrovná schválenému přípravku Leqembi.
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Jim Roppel: How To Find The Next Golden Opportunities As Bull Market Leaders Take A Breather Biogen (BIIB) and Ionis Pharmaceuticals (IONS) said Tuesday their tau-targeting Alzheimer's treatment slowed cognitive decline by 26% over the course of 18 months. The results nearly match Biogen and Eisai's approved drug, Leqembi, which slowed cognitive decline by 27% over its 18-month, final-phase study. Eli Lilly's (LLY) rival drug, Kisunla, led to a 35% slower decline on the same scale,…
Eisai a Biogen uvedly, že subkutánní autoinjektor LEQEMBI má u rané Alzheimerovy choroby srovnatelnou účinnost i bezpečnost jako intravenózní forma. Data ukázala bioekvivalenci při dávce 500 mg jednou týdně vůči iniciačnímu intravenóznímu režimu 10 mg/kg každé dva týdny.
New clinical and real-world data support a subcutaneous treatment pathway from initiation through maintenance treatment, offering dosing convenience for patients and care partners
, /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that new data presented at the Alzheimer's Association International Conference® (AAIC®) 2026 in London support that the LEQEMBI® (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration for people with early Alzheimer's disease (AD). The data was featured during the "Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations" Developing Topics Session #1-32-FRS-C.
AD is a chronic, progressive disease that requires ongoing treatment. LEQEMBI is an early AD treatment that targets the underlying pathology of the disease, helping to slow cognitive decline and loss of daily functioning. The lecanemab subcutaneous auto‑injector (SC‑AI) was developed to provide a more convenient alternative to intravenous (IV) dosing from the initiation of treatment.
Key Findings
This session presented data from the lecanemab SC-AI development program in early Alzheimer's disease, including pharmacokinetic (PK), pharmacodynamic (PD), efficacy, safety and real-world patient and care partner experience findings. Results showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved intravenous (IV) initiation regimen (10 mg/kg every two weeks), supporting the expectation of similar clinical efficacy and safety, independent of the route of administration.
If approved by the United States Food and Drug Administration (FDA), subcutaneous dosing for initiation may offer a convenient at-home alternative to IV infusion which could support access and delivery of care across healthcare settings.
Data Showed
Bioequivalence Achieved: Once-weekly 500 mg SC-AI demonstrated bioequivalence to the IV initiation regimen (10 mg/kg every two weeks), with an exposure ratio of 104% (90% confidence interval [CI]: 99.1%–109%). Exposure remained consistent across body weight quartiles, demonstrating a stable pharmacokinetic profile in a broad patient population. Efficacy Driven by Exposure, Not Route of Administration: Amyloid removal measured by amyloid PET, clinical efficacy measured by CDR-SB, and the incidence of ARIA-E were driven by lecanemab exposure rather than route of administration. The 500 mg SC-AI initiation regimen achieved exposure comparable to the IV initiation regimen, supporting the expectation of a comparable efficacy and safety profile despite the different route of administration. Consistent Results Across Patient Populations: The 500 mg SC-AI initiation regimen demonstrated consistent exposure, amyloid clearance as measured by amyloid PET, clinical efficacy and safety across body weight groups. In addition, amyloid clearance and clinical outcomes were not meaningfully affected by body weight, supporting the appropriateness of a fixed-dose regimen. Flexible switching between IV and SC administration: Patients may also switch from IV to SC administration, or vice versa, and if a dose is missed patients can take it the next day or up to day six providing greater convenience and flexibility in LEQEMBI administration. Safety Profile Aligned of SC LEQEMBI
Overall safety profile of SC-AI was generally consistent with that observed for the IV formulation. Incidence of ARIA-E with the 500 mg SC-AI initiation regimen was predicted to be similar to that observed with the IV initiation regimen. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed. The incidence of anti-drug antibodies (ADA) was low, at 1.4% in the 500 mg SC-AI group. No neutralizing antibodies were observed, confirming that the low immunogenicity profile was maintained with the SC-AI formulation. Clinical Trial Perspectives and Real-World Evidence: Sustained Clinical Benefit with SC-AI
Data from two U.S. Alzheimer's treatment centers (Alzheimer's Research and Treatment Center, and First Choice Neurology and Visionary Investigators Network) provide early insight into clinical trial and real-world use of subcutaneous LEQEMBI: At Alzheimer's Research and Treatment Center, 28 patients receiving SC administration demonstrated slower cognitive decline as measured by CDR-SB over 36 months relative to a matched Alzheimer's Disease Neuroimaging Initiative (ADNI) natural history cohort. The cohort included 25 patients newly initiated on SC administration and 3 patients who transitioned from IV administration. In a separate case series from First Choice Neurology and Visionary Investigators Network, 10 of 11 evaluable patients (91%) showed improvement or remained stable on MMSE compared with baseline before maintenance therapy. At this center, patients who had received maintenance therapy with SC administration for at least 6 months were included in the analysis. Patient and care partner surveys in these two sites demonstrated high satisfaction with subcutaneous LEQEMBI administration, with satisfaction rates ranging from 75% to 97%, convenience ratings from 83% to 97%, and willingness to recommend treatment ranging from 92% to 100%. Results presented in this session further reinforce the importance of early and continuous treatment, highlighting how LEQEMBI SC initiation and maintenance administration provides greater optionality for long-term disease management.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
MEDIA CONTACTS
Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0)3-3817-5120
Eisai Europe, Ltd.
EMEA Communications Department
+44 (0) 797 487 9419
[email protected]
Eisai Inc. (U.S.)
Libby Holman
+1201-753-1945
[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.
Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai, and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.
About Protofibrils
Protofibrils are thought to be the most toxic 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.1 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.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, which are available on the SEC's website at www.sec.gov.
These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.
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.
Biogen kupuje RayThera až za 1 miliardu USD, aby posílil své imunologické portfolio. Firma zatím neprozradila přesné cíle kandidátů, ale hlavní kandidát má vstoupit do fáze 1 ve třetím čtvrtletí.
Biogen (BIIB +3.04%) built itself into a biotech giant thanks to its portfolio of multiple sclerosis (MS) drugs -- but in biotech and pharma, revenue growth depends on the life of a patent. Once a company loses exclusivity, generics or biosimilars enter the market, and the leader's drug sales decline. This is the challenge Biogen has faced in recent years, as MS blockbusters faced growing competition.
But the biotech giant put into place a recovery and growth plan, shifting many costs out of the MS franchise and into areas that represented growth potential. Biogen also made strategic acquisitions, announcing its intention to buy Apellis Pharmaceuticals, an immunology and rare diseases drug company, in March and closing the deal in May.
And just recently, Biogen announced another purchase. This time, the biotech is paying $1 billion for a company that won't say what it makes. Here's why this actually is good news for Biogen investors.
Image source: Getty Images.
Biogen's multiple sclerosis business Let's start with a quick update on Biogen. As mentioned, the biotech company was once known as an MS giant, and it still sells a number of important MS drugs, such as Tecfidera and Tysabri. But loss of exclusivity made a significant dent in revenue, with Tecfidera's peak sales of $4.4 billion in 2019 dropping to $1.4 billion in 2022. In the latest fiscal year, all of Biogen's MS drugs, together, delivered $4 billion in revenue, further highlighting this decline.
In the recent quarter, chief executive officer Christopher Viehbacher said that after four years of declining earnings in 2023, the turnaround began -- and Biogen finally has been able to "stabilize the business." The shift of focus to growth products helped these drugs deliver a 12% increase in sales to $850 million in the first quarter. These are key neurology drugs such as Leqembi for Alzheimer's disease, Skyclarys for Friedreich ataxia, and postpartum depression drug Zurzuvae. They each brought in double- or triple-digit sales growth.
And though Biogen hasn't returned to its peak earnings levels, it looks like a rebound is taking shape, and this may lead to fresh growth.
BIIB Net Income (Quarterly) data by YCharts
Acquisitions to support growth Biogen, of course, has a solid internal pipeline, but the company, aiming to make immunology another key area, has used acquisitions to gain strength here. As mentioned, Biogen bought Apellis, gaining access to two commercialized drugs in this specialty area: Empaveli for three indications, including two rare kidney diseases, and Syfovre for an immune-mediated retinal disease. These drugs together delivered sales of $689 million last year.
Now, let's consider the company's very latest move, and that's to acquire RayThera for as much as $1 billion, including an upfront payment and potential milestone payments. RayThera's website doesn't offer much detail about its candidates -- we don't know the exact diseases they target. What we do know, from the acquisition press release, is that the portfolio "includes multiple anti-inflammatory assets that could potentially treat immune-mediated conditions across a range of indications." And the company's lead candidate is on track to enter a phase 1 trial in the third quarter.
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Why is all of this good news for shareholders? The above statement suggests that RayThera's candidates aren't just targeting a disease or two. Instead, they might have the ability to treat a significant number of immune-mediated illnesses, and that could equal enormous revenue potential down the road. The global immunology market is massive, totaling more than $112 billion last year, according to Fortune Business Insights. Since Biogen is seeking to build out its immunology business, this addition could be a very wise move.
Of course, it's important to keep in mind that a lead candidate that's about to enter phase 1 doesn't result in revenue right away. The RayThera assets, even if successful through clinical trials, will take years to reach the commercialization stage. But that's OK. A biotech company must have a deep pipeline to generate the winning drugs of tomorrow. So acquiring Apellis to gain access to already commercialized drugs and buying RayThera for its pipeline were great strategic moves.
Biogen, after a few tough years, seems to be on the right track toward building out new growth businesses that may deliver over time -- and this is a solid reason to buy and hold the shares.
Biogen na AAIC 2026 ukáže nová data z fáze 2 studie CELIA pro diranersen u časné Alzheimerovy choroby, včetně klinických, biomarkerových a bezpečnostních výsledků. Představí také nové analýzy lecanemabu.
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.
Biogen uvedl, že jeho růstové produkty v 1. čtvrtletí vygenerovaly tržby 851 milionů USD, což je meziročně o 12 % více. Nové léky ale zatím nestačí kompenzovat pokles tržeb z franšízy na roztroušenou sklerózu.
Key Takeaways Biogen's newer drugs are growing but remain insufficient to offset declining MS franchise sales.Leqembi's subcutaneous autoinjector and blood-based diagnostics may support growth from 2027 onward.Biogen's growth products generated $851 million in Q1 sales, up 12% year over year. Biogen (BIIB - Free Report) is in the midst of a major portfolio transition. The company is seeing declining sales of its key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza, due to generic erosion, increasing competition from newer therapies and pricing headwinds.
To combat the pressure on key drugs, Biogen has been aggressively building a new growth engine around recently launched products, Eisai-partnered Leqembi for Alzheimer’s disease, Skyclarys for Friedreich’s ataxia, Qalsody for amyotrophic lateral sclerosis (ALS) and Supernus Pharmaceuticals (SUPN - Free Report) -partnered Zurzuvae for depression.
The key question for investors is whether these products can eventually compensate for the erosion of blockbuster drugs like Tecfidera, Tysabri and Spinraza. Let us discuss.
Key Multiple Sclerosis Drugs, Spinraza Face Increased CompetitionBiogen’s MS sales are declining due to generic competition for Tecfidera globally, biosimilar competition for Tysabri in Europe and rising competitive pressure in the MS market.
In 2026, Biogen expects revenues for MS products, excluding Vumerity, to decline by a mid-teen percentage versus 2025 due to increased competitive pressure on the ex-U.S. MS business, particularly accelerating generic competition for Tecfidera in Europe.
Spinraza’s sales are also declining due to lower demand amid increasing competitive pressure from newer SMA treatments, including gene therapies and oral medicines that offer greater convenience. Spinraza faces competition from Novartis’ (NVS - Free Report) gene therapy, Zolgensma, and Roche and PTC Therapeutics’ (PTCT - Free Report) Evrysdi (risdiplam), which comes as either a liquid solution or an oral tablet.
BIIB’s New Drug Contributing to Top-Line GrowthAmid declining demand for MS drugs and Spinraza, Biogen believes its new products, Leqembi, Skyclarys and Zurzuvae have the potential to return the company to revenue growth.
The largest opportunity in Biogen's new portfolio is arguably Leqembi. Leqembi/lecanemab gained approval for early Alzheimer’s disease in the United States in 2023. Though the Leqembi launch was slow, it picked up in 2024 and 2025. Leqembi has also been launched in Japan, China, the EU and some other countries. Leqembi commands over 60% of the anti-amyloid therapy market share in the United States.
A less frequent maintenance intravenous dosing version of Leqembi was approved by the FDA in January 2025. A subcutaneous autoinjector for maintenance dosing called Leqembi Iqlik was launched in October 2025, while a supplemental filing seeking approval of the Leqembi Iqlik subcutaneous autoinjector for initiation dosing has been granted priority review by the FDA, with a decision expected in August. Biogen and Eisai believe that the introduction of blood-based diagnostics (which can help earlier detection of Alzheimer’s) and the subcutaneous autoinjector for maintenance and initiation should drive Leqembi’s growth from 2027 onward.
Other new products, Qalsody, Biogen/Supernus’ Zurzuvae and Skyclarys (added from the 2023 acquisition of Reata Pharmaceuticals) are also seeing strong demand trends in the United States.
Skyclarys is seeing strong demand trends in the United States as well as the EU. Biogen expects Skyclarys’ future growth to come from ex U.S. markets as the launches advance. Zurzuvae’s launch also exceeded the company’s internal expectations, with sales more than doubling in 2025. Skyclarys and Zurzuvae’s sales are expected to continue to rise in 2026.
Biogen’s growth products (Skyclarys, Qalsody, Zurzuvae, Vumerity and Spinraza plus Alzheimer’s revenues from the Leqembi collaboration) generated sales of $851 million in the first quarter, rising 12% year over year.
In April, Biogen closed its acquisition of Apellis Pharmaceuticals, adding the commercialized medicines Empaveli and Syfovre for immune-mediated retinal disease and nephrology to its commercial portfolio. These drugs should also contribute to Biogen’s growth in future quarters.
Can BIIB’s New Drugs Offset Key Drugs’ Erosion?After declining for several years, Biogen’s revenues have somewhat stabilized since 2024 due to contributions from newer products and pipeline progress. However, its newer drugs, Leqembi, Skyclarys, Qalsody and Zurzuvae, are currently insufficient to offset the near-term top-line decline of the MS franchise. Though all these new drugs are showing signs of growth, replacing lost revenues from Tecfidera, Tysabri and Spinraza will likely take time.
BIIB’s Price Performance, Valuation and EstimatesBiogen’s stock has risen 14.8% so far this year compared with an increase of 5.4% for the industry.
Image Source: Zacks Investment Research
From a valuation standpoint, Biogen is reasonably priced. Going by the price/earnings ratio, the company’s shares currently trade at 13.44 forward earnings, which is lower than 17.72 for the industry. The stock is trading above its five-year mean of 13.17.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for earnings has declined from $15.04 per share to $13.99 per share for 2026 over the past 60 days. For 2027, the consensus mark for earnings has declined from $16.61 to $16.22 per share over the same time frame.
Image Source: Zacks Investment Research
Biogen has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biogen se dohodl na koupi RayThera až za 1 miliardu USD, čímž posiluje svůj imunologický pipeline. Hlavní kandidát má vstoupit do fáze 1 na začátku 3. čtvrtletí 2026.
Acquisition adds multiple immunology assets to Biogen’s portfolio, including a lead asset poised to enter Phase 1 development June 17, 2026 18:59 ET | Source: Biogen Inc.
CAMBRIDGE, Mass. and SAN DIEGO, June 17, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and RayThera Inc., a private biotechnology company focused on discovering and developing small molecule therapies in immunology, today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire RayThera Inc. for up to $1 billion, consisting of an upfront payment and, predominantly, payments contingent on the achievement of future clinical and regulatory milestones.
RayThera’s portfolio includes multiple anti-inflammatory assets that could potentially treat immune-mediated conditions across a range of indications. The lead candidate is expected to enter Phase 1 development in early Q3 2026.
“With this acquisition, we are further deepening our pipeline in immunology by adding a suite of assets that can allow us to expand into new disease areas,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “We believe these assets can meaningfully contribute to our long-term pipeline potential and we’re excited about the opportunity to rapidly advance the first candidate into the clinic.”
“With its strong global development capabilities in immunology, we believe that Biogen is the natural fit to move these assets forward into Phase 1 development and beyond,” said Qing Dong, co-founder, Chairman and CEO of RayThera. “I am proud of our team at RayThera for the innovative pipeline we have built together and the rapid advancement of these molecules.”
Financial Details and Terms of the Transaction
Under the terms of the agreement, Biogen will make an upfront payment to RayThera’s shareholders, who would also be eligible for clinical and regulatory milestone payments for a total potential deal value of up to $1 billion. The transaction is subject to customary closing conditions, including receipt of necessary regulatory approvals and is currently anticipated to close in the third quarter of 2026. With the acquisition, once closed, Biogen will lead development, manufacturing and global commercialization of these assets.
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.
About RayThera, Inc.
RayThera, Inc. is a small molecule drug discovery company focused on building an immunology pipeline. Based in San Diego, CA, and co-founded by Qing Dong, Ph.D., and Gene Hung, M.D., the company is led by a team of accomplished drug discovery leaders and executives with a proven track record across the biotech and pharma industries. RayThera recently completed its Series A financing co-led by Foresite Capital and OrbiMed Advisors, with participation from TTM Capital. For more information, visit www.raythera.com.
Biogen Safe Harbor
This press release contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 (the PSLRA) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the PSLRA. This press release contains forward-looking statements, relating to: the anticipated benefits of the RayThera Inc. acquisition (the “Acquisition”), our strategy and our future financial and operating results, costs and other anticipated financial impacts of the Acquisition, and our long-term pipeline potential in immunology. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part.
We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, factors relating to: the possibility that the thresholds for clinical and regulatory milestone payments are never met; results of litigation, settlements and investigations; actions by third parties, including governmental agencies; unexpected costs, charges or expenses resulting from the Acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Acquisition; the risk that Biogen may not be able to successfully integrate the business of RayThera and realize the expected benefits of the Acquisition in a timely manner or at all; uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.
These statements speak only as of date hereof and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated, or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
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.
