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 (BIIB) delivers pioneering therapies for neurological disorders through cutting-edge biotechnology research. This page aggregates all official announcements, regulatory developments, and strategic updates directly from the company and verified sources.
Investors and healthcare professionals will find timely updates on clinical trial results, FDA approvals, earnings reports, and research partnerships. Track Biogen's progress in Alzheimer's disease treatments, multiple sclerosis therapies, and rare condition solutions through curated press releases and analysis.
Our news hub simplifies monitoring Biogen's pipeline advancements and market position. Key content includes product launch details, executive leadership changes, collaboration announcements, and financial performance data. All information is organized chronologically for efficient research and decision-making.
Bookmark this page for streamlined access to Biogen's latest developments in neuroscience innovation. Verify publication dates and consult original SEC filings for complete context on all disclosed information.
Biogen (Nasdaq: BIIB) and Eisai announced completion of the rolling submission of an sBLA to the U.S. FDA on Nov 25, 2025 seeking approval of LEQEMBI IQLIK (lecanemab-irmb) as a 500 mg once-weekly subcutaneous starting dose after the FDA granted Fast Track Status. Company data show the 500 mg SC autoinjector (two 250 mg injections) achieved equivalent exposure to IV dosing every two weeks with similar clinical and biomarker effects and a safety profile comparable to IV administration (~<2% systemic injection/infusion reactions). If approved, IQLIK would allow at-home initiation and maintenance dosing and could reduce IV infusion resource needs; FDA will set a PDUFA action date upon sBLA acceptance.
Biogen (Nasdaq: BIIB) and Dayra Therapeutics announced a research collaboration on November 24, 2025 to discover and develop oral macrocyclic peptides for priority immunological targets.
Key terms include a $50 million upfront payment to Dayra, program-level option and milestone payments, and Biogen leading further development, manufacturing, and potential commercialization. Biogen will record the upfront as an Acquired In-Process R&D expense in Q4 2025, and the amount was included in Biogen’s updated 2025 guidance issued October 30, 2025.
Biogen (Nasdaq: BIIB) will present new clinical and real-world lecanemab (LEQEMBI) data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference, Dec 1–4, 2025, in San Diego.
Highlights include subcutaneous initiation dosing safety and feasibility, evidence that continued treatment may yield additional long-term clinical benefit, an analysis estimating 10‑year time‑savings based on Phase 3 data, and interim real-world findings from a post‑marketing study in Japan and the ALZ‑NET registry. Biogen will also share biodistribution data for investigational ASO BIIB080 and research on disease‑progression measures.
Biogen (Nasdaq: BIIB) and Stoke Therapeutics published final two-year natural history data from the BUTTERFLY study in Neurology on November 14, 2025, describing disease course in children and adolescents (ages 2–18) with Dravet syndrome.
Key findings: neurodevelopment plateaued at a developmental age of ~2 years regardless of entry age, creating a widening gap versus typical development; major motor seizure frequency rose 10.6% over two years (baseline 14.3 seizures/28 days; p=0.63; n=23). Study used pre-specified adaptive and cognitive measures aligned with endpoints in the Phase 3 EMPEROR trial of zorevunersen.
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.
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).
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