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) 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).
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.