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) announced a positive CHMP opinion recommending approval of a high dose regimen of nusinersen for 5q spinal muscular atrophy, with a final European Commission decision expected in January 2026.
The CHMP opinion is based on the Phase 2/3 DEVOTE study: Part B (n=75) showed a mean CHOP-INTEND difference of 26.19 points (+15.1 vs -11.1; p<0.0001) and a 68% reduction in risk of death or permanent ventilation versus a matched sham group. Part C (n=38) reported a HFMSE mean increase of 1.8 points at Day 302 after switching from 12 mg. Dosing: two 50 mg loading doses 14 days apart then 28 mg every 4 months (single 50 mg loading for switchers). Safety was generally consistent with known profile; common AEs included pneumonia, COVID-19, aspiration pneumonia, and malnutrition.
Biogen (Nasdaq: BIIB) completed its acquisition of Alcyone Therapeutics on Nov 14, 2025, gaining the investigational implantable drug delivery device ThecaFlex DRx™.
ThecaFlex DRx™ is designed to reduce repeat lumbar punctures for chronic intrathecal administration and has been in development since 2019 with the PIERRE and PIERRE-PK clinical studies for nusinersen (SPINRAZA®) currently underway. Biogen plans to introduce the delivery system for SPINRAZA in early 2028, contingent on successful clinical trial completion and regulatory approval. Biogen cites the acquisition as a way to combine its biopharmaceutical capabilities with device technology to potentially improve patient experience and broaden access to therapies.
Biogen (NASDAQ: BIIB) will present new clinical and translational data for felzartamab, an investigational anti-CD38 monoclonal antibody, at ASN Kidney Week 2025 in Houston (Nov 5–9, 2025).
Key highlights include a first-of-its-kind longitudinal whole blood RNAseq dataset from the Phase 2 IGNAZ study linking gene expression changes to felzartamab’s mechanism in IgA nephropathy, and Phase 2 data showing preservation of humoral immunity and vaccine responses in felzartamab-treated patients. Biogen also notes three pivotal Phase 3 studies initiated in 2025, with the first readout (TRANSCEND) anticipated in 2027. Multiple oral, poster, and exhibitor presentations will cover AMR, IgAN, and primary membranous nephropathy.
Biogen (Nasdaq: BIIB) licensed Vanqua Bio’s preclinical oral C5aR1 antagonist, gaining exclusive worldwide rights to a peripherally-directed program aimed at neutrophil-driven inflammation.
Key deal terms: a $70 million upfront payment, up to $990 million in development/regulatory/commercial milestones, and tiered royalties on net sales. Biogen will record the upfront as an Acquired In-Process R&D expense in Q4 2025 and will lead development, manufacturing and commercialization. Biogen expects, if supportive data continue, to file an IND in 2027.
Biogen (Nasdaq: BIIB) will present additional results from Phase 3 studies of dapirolizumab pegol (DZP) in systemic lupus erythematosus (SLE) at ACR Convergence 2025 (Oct 24-29).
Presentations report DZP met the primary endpoint (BICLA) at 48 weeks, show efficacy across multiple endpoints including low disease activity/remission, flares, fatigue, joint pain and quality of life, and include preclinical/ex vivo data indicating minimal to no human placental transfer. One key secondary endpoint had p = 0.1776, making subsequent secondary/tertiary results descriptive with nominal p-values.
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.
Eisai and Biogen (Nasdaq: BIIB) announced that LEQEMBI IQLIK, a subcutaneous autoinjector formulation of lecanemab for early Alzheimer’s disease, was named to TIME’s Best Inventions of 2025 in Medical & Healthcare.
LEQEMBI IQLIK was approved in the U.S. in August 2025, launched on October 6, 2025, and offers an at‑home injection (~15 seconds) for maintenance dosing after an 18‑month IV initiation period. Eisai has initiated a rolling sBLA to the FDA for a subcutaneous starting dose under Fast Track. Phase 3 Clarity AD data showed a 27% reduction in clinical decline on CDR‑SB at 18 months (difference −0.45; 95% CI −0.67 to −0.23; P<0.001).
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.