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    Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease

    10/6/25 4:30:00 PM ET
    $BIIB
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $BIIB alert in real time by email

    New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more

    LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months

    TOKYO and CAMBRIDGE, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

    Eisai and Biogen have also launched the LEQEMBI Companion™ program, an initiative rooted in both companies' commitment to providing access to LEQEMBI and resources for people living with early Alzheimer's disease. The program aims to provide expanded resources that support patients throughout their LEQEMBI treatment journey, from initiation through maintenance therapy.

    In addition to the current resources already provided (e.g., help with understanding insurance coverage and potential out-of-pocket costs and identifying financial support programs), the new LEQEMBI Companion program will now offer patients:

    • Injection education through Nurse Educators either in-person or virtually to provide patients with training on injecting their maintenance dose using the LEQEMBI IQLIK (nurse educators train on the device only; patients should discuss any treatment-related questions with their doctor).
    • A welcome kit that includes educational resources to help patients and care partners know what to expect, prepare for at-home injections, and more.

    Designed to serve as a digital solution to help support patients and care partners along their treatment journey, the LEQEMBI Companion app was developed with Medisafe, a digital patient engagement and medication management platform. From educational information about the injection process to a tool for tracking where and when injections occur, the LEQEMBI Companion app offers resources and more all in one place. Patients can visit LEQEMBI.com/CompanionAppSignUp to get started.

    To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured and underinsured patients, who meet financial need and other program criteria.

    To learn more, or if you are already enrolled and have questions, visit LEQEMBI.com/PatientSupport or call 1-833-4-LEQEMBI (1-833-453-7362), Monday-Friday, 8 a.m. to 8 p.m. Eastern Time.

    AD is a progressive, relentless disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. It is caused by a continuous underlying neurotoxic process that begins before amyloid plaque accumulation and continues after plaque removal.1-3 The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process,4-6 and only LEQEMBI fights AD in two ways – targeting both amyloid plaque and protofibrils*, which can impact tau downstream.

    Due to the reaccumulation of AD biomarkers and return to placebo rate of decline after therapy is stopped,4-5 continuing maintenance treatment after the initial 18-month therapy is essential to slow the progression of AD and extend the therapeutic benefits, helping patients maintain who they are for longer.

    The availability of LEQEMBI IQLIK in the U.S. offers patients and care partners the ability to use the device at home, shortening treatment time, and providing an option to continue treatment without having to worry about visiting an infusion center. The LEQEMBI IQLIK also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while increasing infusion capacity for new eligible patients to begin initiation treatment and streamlining the overall AD treatment pathway.

    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.

    * 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.6 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.5

    INDICATION

    LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

    IMPORTANT SAFETY INFORMATION

             WARNING: AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA)
    • Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI.
      • Apolipoprotein E ε4 (ApoE ε4) Homozygotes: Patients who are ApoE ε4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE ε4 homozygotes and at higher risk for ARIA.
    • Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI.
     

    CONTRAINDICATION

    Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis.

    WARNINGS AND PRECAUTIONS

    AMYLOID-RELATED IMAGING ABNORMALITIES

    Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time.

    Incidence of ARIA

    Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation. ARIA, including asymptomatic radiographic events, was observed: LEQEMBI, 21%; placebo, 9%. ARIA-E was observed: LEQEMBI, 13%; placebo, 2%. ARIA-H was observed: LEQEMBI, 17%; placebo, 9%. No increase in isolated ARIA-H was observed for LEQEMBI vs placebo.

    Incidence of ICH

    ICH >1 cm in diameter was reported in 0.7% with LEQEMBI vs 0.1% with placebo. Fatal events of ICH in patients taking LEQEMBI have been observed.

    Risk Factors of ARIA and ICH

    ApoE ε4 Carrier Status

    Of the patients taking LEQEMBI, 16% were ApoE ε4 homozygotes, 53% were heterozygotes, and 31% were noncarriers. With LEQEMBI, ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes vs 2% of heterozygotes and 1% of noncarriers. Serious ARIA events occurred in 3% of ApoE ε4 homozygotes and in ~1% of heterozygotes and noncarriers. The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

    Radiographic Findings of CAA

    Neuroimaging findings that may indicate CAA include evidence of prior ICH, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for ICH. The presence of an ApoE ε4 allele is also associated with CAA.

    The baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, have been identified as risk factors for ARIA. Patients were excluded from Clarity AD for the presence of >4 microhemorrhages and additional findings suggestive of CAA (prior cerebral hemorrhage >1 cm in greatest diameter, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of ICH.

    Concomitant Antithrombotic or Thrombolytic Medication

    In Clarity AD, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. Most exposures were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of ICH: 0.9% in patients taking LEQEMBI with a concomitant antithrombotic medication vs 0.6% with no antithrombotic and 2.5% in patients taking LEQEMBI with an anticoagulant alone or with antiplatelet medication such as aspirin vs none in patients receiving placebo.

    Fatal cerebral hemorrhage has occurred in 1 patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent.

    Additional caution should be exercised when considering the administration of antithrombotics or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with LEQEMBI.

    Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for ICH and, in particular, patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of CAA.

    Radiographic Severity With LEQEMBI

    Most ARIA-E radiographic events occurred within the first 7 doses, although ARIA can occur at any time, and patients can have >1 episode. Maximum radiographic severity of ARIA-E with LEQEMBI was mild in 4%, moderate in 7%, and severe in 1% of patients. Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. Maximum radiographic severity of ARIA-H microhemorrhage with LEQEMBI was mild in 9%, moderate in 2%, and severe in 3% of patients; superficial siderosis was mild in 4%, moderate in 1%, and severe in 0.4% of patients. With LEQEMBI, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes (5%) vs heterozygotes (0.4%) or noncarriers (0%). With LEQEMBI, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (13.5%) vs heterozygotes (2.1%) or noncarriers (1.1%).

    Monitoring and Dose Management Guidelines

    Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment. Depending on ARIA-E and ARIA-H clinical symptoms and radiographic severity, use clinical judgment when considering whether to continue dosing or to temporarily or permanently discontinue LEQEMBI. If a patient experiences ARIA symptoms, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.

    HYPERSENSITIVITY REACTIONS

    Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred with LEQEMBI. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.

    INFUSION-RELATED REACTIONS (IRRs)

    IRRs were observed—LEQEMBI: 26%; placebo: 7%—and most cases with LEQEMBI (75%) occurred with the first infusion. IRRs were mostly mild (69%) or moderate (28%). Symptoms included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.

    IRRs can occur during or after the completion of infusion. In the event of an IRR during the infusion, the infusion rate may be reduced or discontinued, and appropriate therapy initiated as clinically indicated. Consider prophylactic treatment prior to future infusions with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids.

    ADVERSE REACTIONS

    • The most common adverse reactions reported in ≥5% with LEQEMBI infusion every 2 weeks and ≥2% higher than placebo were IRRs (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%)
    • Safety profile of LEQEMBI IQLIK for maintenance treatment was similar to LEQEMBI infusion. Patients who received LEQEMBI IQLIK experienced localized and systemic (less frequent) injection-related reactions (mild to moderate in severity)

    LEQEMBI (lecanemab-irmb) is available:

    • Intravenous infusion: 100 mg/mL
    • Subcutaneous injection: 200 mg/mL

    Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

    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

    +1-201-753-1945

    [email protected]

    Biogen Inc.

    Madeleine Shin 

    +1-781-464-3260

    [email protected]



      
    INVESTOR CONTACTS 
    Eisai Co., Ltd.

    Investor Relations Department

    TEL: +81 (0) 3-3817-5122
    Biogen Inc.

    Tim Power

    + 1-781-464-2442

    [email protected]

    Notes to Editors

    1. 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 50 countries and is under regulatory review in 8 countries. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S., and application have been filed in nine (9) countries and regions.



      LEQEMBI's approvals in these countries was based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with lecanemab reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001). In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the lecanemab group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.



      The subcutaneous maintenance dosing approval is based on LEQEMBI subcutaneous (SC) sub-studies of the Phase 3 Clarity AD open-label extension (OLE) trial in individuals with early AD which evaluated a range of subcutaneous doses. Data shows that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing. The safety of LEQEMBI IQLIK autoinjector was studied in over 600 patients at a range of doses as part of the Clarity AD OLE. Across all subcutaneous doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with subcutaneous dosing—less than 1% compared to approximately 26% with IV infusions. ARIA rates in patients who received a weekly 360 mg subcutaneous maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after 18 months and are similar to the background rates of ARIA in patients without treatment.



      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.



    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.



    3. 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.



    4. 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.



    5. About Biogen 

      Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.



      The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.



      Biogen Safe Harbor

      This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for lecanemab-irmb (LEQEMBI IQLIK); the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would," and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.



      These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned "Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

    References

    1. LEQEMBI (lecanemab-irmb) injection, for intravenous use [package insert]. Nutley, NJ: Eisai Inc.
    2. Iwatsubo T, Irizarry M, van Dyck C, Sabbagh M, Bateman RJ, Cohen S. Clarity AD: a phase 3 placebo-controlled, double-blind, parallel-group, 18-month study evaluating lecanemab in early Alzheimer's disease. Presented at: CTAD Conference; November 29-December 2, 2022; San Francisco, CA.
    3. Hampel H, Hardy J, Blennow K, et al. The amyloid-? pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503.
    4. 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
    5. 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.
    6. Morris JC. Neurology. 1993;43(11):2412-4.


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    FDA Approval for VUMERITY issued to BIOGEN INC

    Submission status for BIOGEN INC's drug VUMERITY (ORIG-1) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 09/12/2024. Application Category: NDA, Application Number: 761347, Application Classification: Type 3 - New Dosage Form

    9/16/24 6:52:10 AM ET
    $BIIB
    Biotechnology: Biological Products (No Diagnostic Substances)
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    FDA Approval for VUMERITY issued to BIOGEN INC

    Submission status for BIOGEN INC's drug VUMERITY (SUPPL-17) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 09/11/2024. Application Category: NDA, Application Number: 211855, Application Classification: Manufacturing (CMC)

    9/16/24 6:24:32 AM ET
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    Biotechnology: Biological Products (No Diagnostic Substances)
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    FDA Approval for VUMERITY issued to BIOGEN INC

    Submission status for BIOGEN INC's drug VUMERITY (SUPPL-15) with active ingredient DIROXIMEL FUMARATE has changed to 'Approval' on 03/22/2024. Application Category: NDA, Application Number: 211855, Application Classification: Labeling

    3/25/24 4:41:37 AM ET
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    SEC Filings

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    Biogen Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

    8-K - BIOGEN INC. (0000875045) (Filer)

    7/31/25 6:13:54 AM ET
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    Biotechnology: Biological Products (No Diagnostic Substances)
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    SEC Form 10-Q filed by Biogen Inc.

    10-Q - BIOGEN INC. (0000875045) (Filer)

    7/31/25 6:05:42 AM ET
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    Biotechnology: Biological Products (No Diagnostic Substances)
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    Biogen Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

    8-K - BIOGEN INC. (0000875045) (Filer)

    7/7/25 4:10:34 PM ET
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    Biotechnology: Biological Products (No Diagnostic Substances)
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    Press Releases

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    Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease

    New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that lecanemab-irmb subcutaneous inj

    10/6/25 4:30:00 PM ET
    $BIIB
    Biotechnology: Biological Products (No Diagnostic Substances)
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    "LEQEMBI®" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in China

    TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (brand name in China: "乐意保®", generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China. In January 2024, LEQEMBI was approved for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild d

    9/28/25 7:30:00 PM ET
    $BIIB
    Biotechnology: Biological Products (No Diagnostic Substances)
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    LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Australia

    TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD) (collectively referred to as early AD) in adults who are either ApoEε4* non-carriers or heterozygous carriers. In response to February 2025 TGA de

    9/24/25 7:30:00 AM ET
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    $BIIB
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

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    Director Dorsa Caroline bought $151,559 worth of shares (1,235 units at $122.72), increasing direct ownership by 5% to 27,842 units (SEC Form 4)

    4 - BIOGEN INC. (0000875045) (Issuer)

    5/5/25 4:17:10 PM ET
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    Rowinsky Eric K bought $101,256 worth of shares (455 units at $222.54), increasing direct ownership by 2% to 20,629 units (SEC Form 4)

    4 - BIOGEN INC. (0000875045) (Issuer)

    2/20/24 9:13:26 PM ET
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    Financials

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    Biogen to Advance Investigational Spinal Muscular Atrophy Asset to Registrational Studies Based on Positive Interim Phase 1 Results

    Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA)Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersenBased on these encouraging Phase 1 data, Biogen is engaging with regulators to advance salanersen to registrational stage studies, building on extensive experience in SMA CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) announced topline results from the Phase 1 study of

    6/25/25 7:30:37 AM ET
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    $IONS
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    Biotechnology: Pharmaceutical Preparations

    Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.

    Strengthens and expands U.S. biosimilars immunology portfolio with multi-indication arthritis treatment Organon (NYSE:OGN), a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. (NASDAQ:BIIB) regulatory and commercial rights in the U.S. for TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion. TOFIDENCE, the first approved tocilizumab biosimilar entrant in the U.S. market, was launched in May 2024 and is indicated in certain patients for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and

    4/1/25 7:30:00 AM ET
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    $OGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Biotechnology: Pharmaceutical Preparations

    GeneDx Reports Fourth Quarter and Full Year 2024 Financial Results and Issues Guidance for Full Year 2025

    Grew fourth quarter 2024 revenues1 to $95.3 million Expanded fourth quarter 2024 adjusted gross margins1,2 to 70% Generated fourth quarter 2024 adjusted net income2 of $16.8 million FY 2025 revenue guidance of $350M to $360M, exome/genome volume and revenue growth of at least 30% GeneDx to host conference call today at 8:30 a.m. ET GeneDx Holdings Corp. (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the fourth quarter and full year of 2024. "The fourth quarter capped an outstanding year for GeneDx, as we work to end the diagnostic odyssey with earlier intervention using our industry-leading exome and gen

    2/18/25 6:00:00 AM ET
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    Leadership Updates

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    Entrada Therapeutics Appoints Maha Radhakrishnan, M.D., to its Board of Directors

    BOSTON, June 03, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (NASDAQ:TRDA) today announced the appointment of Maha Radhakrishnan, M.D., to its Board of Directors. "We are pleased to have Dr. Radhakrishnan join the Board at this time of tremendous clinical momentum at Entrada, led by the continued advancement of our Duchenne muscular dystrophy franchise. Dr. Radhakrishnan's deep and meaningful experience in global drug development will be invaluable as we quickly advance our novel Duchenne programs into multiple patient-focused clinical trials throughout this year," said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. "I'm honored to join the Board of Entrada

    6/3/25 7:00:00 AM ET
    $BIIB
    $TRDA
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Cardurion Pharmaceuticals Appoints Karen Lewis as Chief People Officer

    Cardurion Pharmaceuticals, Inc. ("Cardurion"), a clinical-stage biotechnology company discovering and developing new therapeutic approaches for the treatment of cardiovascular diseases, today announced that Karen Lewis has joined the company as Chief People Officer. She joins Cardurion with more than 25 years of experience in human resources helping to build organizations and develop programs that support companies at various stages of growth. She most recently was Chief People Officer at Apellis Pharmaceuticals (NASDAQ:APLS) during a period of rapid growth, and previously held leadership roles in human resources at Biogen (NASDAQ:BIIB) and Bristol-Myers Squibb (NYSE:BMY). "We're delighted

    3/20/25 8:00:00 AM ET
    $APLS
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    Biotechnology: Pharmaceutical Preparations
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    Biotechnology: Biological Products (No Diagnostic Substances)

    Cardurion Pharmaceuticals Appoints Charlotte Newman as Chief Business Officer

    Cardurion Pharmaceuticals, Inc. ("Cardurion"), a clinical-stage biotechnology company discovering and developing new therapeutic approaches for the treatment of cardiovascular diseases, today announced that Charlotte (Charlie) Newman has joined the company as Chief Business Officer. A biopharmaceutical industry executive with over 25 years of industry experience, Ms. Newman most recently led corporate, portfolio and program strategy and business development as Chief Business Officer of Agios Pharmaceuticals (NASDAQ:AGIO), and previously held strategic product and portfolio roles at Biogen (NASDAQ:BIIB). In her role at Cardurion, she will be responsible for leading corporate development, bus

    1/8/25 8:00:00 AM ET
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    Large Ownership Changes

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    Amendment: SEC Form SC 13G/A filed by Biogen Inc.

    SC 13G/A - BIOGEN INC. (0000875045) (Subject)

    11/12/24 1:24:28 PM ET
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    Amendment: SEC Form SC 13G/A filed by Biogen Inc.

    SC 13G/A - BIOGEN INC. (0000875045) (Subject)

    11/4/24 11:20:12 AM ET
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    SEC Form SC 13G filed by Biogen Inc.

    SC 13G - BIOGEN INC. (0000875045) (Subject)

    10/16/24 12:11:53 PM ET
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