Welcome to our dedicated page for Biogen news (Ticker: BIIB), a resource for investors and traders seeking the latest updates and insights on Biogen stock.
Biogen Inc. develops and commercializes biopharmaceutical therapies focused on neurodegenerative diseases, rare diseases and adjacent specialty areas. Company news commonly covers Alzheimer’s disease therapy LEQEMBI with Eisai, spinal muscular atrophy treatment SPINRAZA, Friedreich’s ataxia therapy SKYCLARYS, postpartum depression therapy ZURZUVAE, ALS therapy QALSODY, multiple sclerosis products and CD20 collaboration revenue tied to Roche-partnered medicines.
Recurring updates include FDA review activity, supplemental biologics license applications, global regulatory status, clinical development programs, collaboration and licensing economics, asset-rights transactions and product demand trends. Biogen news also includes financial results, acquired in-process research and development expense, governance changes and corporate-status disclosures typical of a Nasdaq-listed biotechnology issuer.
Biogen (Nasdaq: BIIB) and Eisai announced that LEQEMBI IQLIK, a subcutaneous autoinjector formulation of lecanemab for Alzheimer's disease, was named one of TIME's Best Inventions of 2025 in Medical & Healthcare.
Key facts: U.S. approval occurred in August 2025, commercial launch began on October 6, 2025, and Eisai initiated a rolling sBLA in early September 2025 for a subcutaneous starting dose. LEQEMBI IQLIK provides an at-home injection (~15 seconds), aims to reduce IV maintenance resource use, and may expand infusion capacity for new initiations. LEQEMBI is approved in 50 countries and under review in 10 countries. Safety includes ARIA and infusion/ injection reactions; prescribers should follow MRI monitoring and ApoE ε4 testing guidance.
NACD appointed Jesús Mantas and Wes Bricker to its board of directors, effective October 10, 2025. Mantas is recently retired as global leader of IBM Consulting Business Transformation Services and serves on the board of Biogen (Nasdaq: BIIB) where he chairs the compensation and management development committee. Bricker is Global Assurance Leader at PwC, a former SEC chief accountant, and leads PwC assurance teams across the network.
The appointments add expertise in digital transformation, innovation, assurance, governance, and capital markets to NACD as it advises corporate directors on evolving boardroom challenges.
National Association of Corporate Directors (BIIB) announced that Jesús Mantas and Wes Bricker joined the NACD board of directors effective Oct. 10, 2025. Mantas, recently retired as global leader of IBM Business Transformation Services, serves on the board of Biogen (Nasdaq: BIIB) and chairs its compensation and management development committee. Bricker is Global Assurance Leader at PwC and a former SEC chief accountant, overseeing 134,000 assurance partners and staff across the PwC network. The appointments emphasize expertise in governance, digital transformation, audit, and capital markets.
Biogen (Nasdaq: BIIB) and Stoke Therapeutics presented longer-term open-label extension data for zorevunersen at the 54th Child Neurology Society Annual Meeting on Oct 9, 2025. Two‑year analyses showed continuing improvements in cognition and behavior versus minimal change in a two‑year natural history cohort. Clinician and caregiver Global Impression scales reported similar overall clinical improvements in 95% of patients (n=19) at three years. Substantial and durable reductions in major motor seizure frequency were observed through 36 months. Safety data (n=81) showed TEAEs in 30%–53%, CSF protein elevations in 14%–44% (any >50 mg/dL: 42%–86%), one discontinuation, and one SUSAR.
Biogen (NASDAQ: BIIB) and Eisai announced on October 6, 2025 that LEQEMBI IQLIK (lecanemab-irmb) subcutaneous 360 mg weekly maintenance dosing is now available in the U.S. for patients with early Alzheimer’s disease after an initial 18-month IV regimen. The approval follows FDA clearance in August 2025. Patients may continue IV infusions every four weeks or switch to the at-home autoinjector. The companies launched the LEQEMBI Companion program with nurse education, an app, a welcome kit, and a patient assistance program offering LEQEMBI at no cost for eligible patients.
Prescribing information highlights ARIA risks and recommends ApoE ε4 testing and MRI monitoring.
Biogen (NASDAQ:BIIB) and Eisai announced that their Alzheimer's treatment LEQEMBI® (lecanemab) has received approval in China for once-every-four-weeks intravenous maintenance dosing. This approval follows the initial January 2024 authorization for treating early Alzheimer's disease patients with mild cognitive impairment or mild dementia.
The maintenance dosing allows patients to transition from the initial bi-weekly 10 mg/kg dosing to a more convenient monthly schedule after 18 months of treatment. LEQEMBI is notable as the only approved therapy targeting both amyloid plaque and protofibrils, which can impact tau downstream. The market potential is significant, with an estimated 17 million patients with early-stage Alzheimer's in China as of 2024.
Biogen (NASDAQ:BIIB) and Eisai announced that Australia's Therapeutic Goods Administration (TGA) has approved LEQEMBI® (lecanemab) for the treatment of early Alzheimer's disease. The approval specifically targets adults with mild cognitive impairment or mild dementia who are either ApoEε4 non-carriers or heterozygous carriers.
The approval follows a review process initiated in March 2025 after an initial rejection in February 2025. LEQEMBI uniquely targets both toxic protofibrils and amyloid plaque, potentially impacting tau downstream. This approval is particularly significant as Australia faces growing dementia cases, with numbers expected to rise from 425,000 in 2024 to approximately 1,100,000 by 2065.
Biogen (NASDAQ:BIIB) received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application for the high dose regimen of nusinersen in treating spinal muscular atrophy (SMA). The FDA requested updates to technical information in the Chemistry Manufacturing and Controls module, with no concerns cited about clinical data.
The company plans to promptly resubmit the application with readily available information. Notably, the high dose regimen was recently approved in Japan and is under review by the European Medicines Agency (EMA) and other global regulators.
Biogen (Nasdaq: BIIB) has announced its acquisition of Alcyone Therapeutics for an upfront payment of $85 million plus milestone payments. The acquisition centers on ThecaFlex DRx™, an implantable device designed for intrathecal delivery of antisense oligonucleotides (ASOs).
The device aims to provide an alternative to repeat lumbar punctures for chronic medicine administration, initially being evaluated with SPINRAZA® for spinal muscular atrophy patients. Biogen plans to launch the delivery system by early 2028, subject to clinical trials and regulatory approval.
As part of the deal, Alcyone's remaining assets will be divested into a new company, Neela Therapeutics. The transaction includes convertible debt financing in Neela from existing investors, including Biogen.
Biogen (NASDAQ:BIIB) has received European Commission (EC) approval for ZURZUVAE® (zuranolone), marking a significant breakthrough as the first and only treatment approved for postpartum depression (PPD) in Europe. The drug is administered as a once-daily, oral, 14-day treatment.
The approval is based on the successful SKYLARK study, which demonstrated significant reduction in depressive symptoms as early as day 3, with benefits sustained through day 45 compared to placebo. The study met its primary endpoint using the HAMD-17 depression severity scale at day 15.
This approval addresses a critical healthcare need, as up to 20% of European women experience PPD symptoms following pregnancy. ZURZUVAE has already received approvals in the U.S. (August 2023) and U.K. (August 2025).