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. (NASDAQ: BIIB) generates frequent news across neurology, rare diseases and immunology, reflecting its role as a biotechnology company focused on serious neurological and genetic conditions. News coverage for BIIB often centers on clinical trial results, regulatory milestones, scientific publications and strategic collaborations that shape the company’s therapeutic portfolio.
Investors and healthcare observers following Biogen news can expect updates on marketed therapies such as SPINRAZA (nusinersen) for 5q spinal muscular atrophy, QALSODY (tofersen) for SOD1-ALS, and LEQEMBI (lecanemab-irmb) for early Alzheimer’s disease, co-developed with Eisai. Recent announcements have included European Commission approval of a high-dose SPINRAZA regimen, long-term QALSODY data published in JAMA Neurology, and multiple LEQEMBI data presentations at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference, including subcutaneous administration and long-term treatment analyses.
Biogen news also highlights its collaborations and pipeline. Examples include joint updates with Stoke Therapeutics on zorevunersen, an investigational antisense oligonucleotide for Dravet syndrome, and a research collaboration with Dayra Therapeutics to discover oral macrocyclic peptides for immunological conditions. In addition, the company regularly issues press releases on scientific conference presentations, regulatory submissions, and its broader ALS and Alzheimer’s research programs.
This BIIB news page aggregates such developments in one place, helping readers track Biogen’s clinical progress, regulatory interactions and research directions over time. For investors, clinicians and researchers, it offers a focused view of how Biogen’s scientific and business activities evolve across its key therapeutic areas.
Biogen (Nasdaq: BIIB) will present new long‑term and interim clinical data on high dose nusinersen (SPINRAZA) and salanersen at MDA Clinical & Scientific Conference (March 8‑11, 2026) and SMA Europe (March 11‑14, 2026).
Highlights include integrated DEVOTE/ONWARD results for high dose nusinersen, Phase 1b interim salanersen data, designs for salanersen Phase 3 STELLAR/SOLAR studies, and neurofilament biomarker data. SPINRAZA high dose is approved in Japan, EU, and Switzerland and is under FDA review with a decision expected by April 3, 2026.
Biogen (NASDAQ: BIIB) and Stoke Therapeutics announced NEJM publication showing zorevunersen data suggesting potential disease modification in Dravet syndrome.
Phase 1/2a and open‑label extensions reported substantial, durable seizure reductions and multi‑year cognitive, behavioral and quality‑of‑life improvements; 81 patients received drug and >800 doses administered; Phase 3 EMPEROR readout expected mid‑2027.
Stoke Therapeutics (BIIB) announced that CEO Ian F. Smith will present at the TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 2:30 p.m. ET. A live audio webcast and archived replay will be available in the Investors & News section of Stoke’s website.
The company is focused on RNA medicine and is developing zorevunersen as a potential first-in-class disease-modifying treatment for Dravet syndrome.
Biogen (Nasdaq: BIIB) announced that Dr. Maria C. Freire will become Chair of the Board effective immediately after the 2026 Annual Meeting on June 9, 2026, succeeding Caroline Dorsa who will retire and not stand for reelection.
Dr. Freire joined the Board in 2021, serves on two committees, and brings extensive biomedical, public‑private partnership, and drug‑development leadership experience. Management highlighted an 18‑month catalyst period including potential enabling filings in lupus and nephrology.
Stoke Therapeutics (Nasdaq: STOK) announced that CEO Ian F. Smith will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026 at 2:30 p.m. ET.
A live audio webcast and archived replay will be available in the Investors & News section of Stoke's investor website.
Biogen (NASDAQ: BIIB) announced publication in Nature Medicine of pivotal DEVOTE results showing the high-dose nusinersen regimen (50 mg loading, 28 mg maintenance) produced statistically significant motor improvements and faster neurofilament decline versus a prespecified matched sham in infantile-onset SMA.
DEVOTE enrolled 139 participants; Part B infants showed a CHOP-INTEND mean difference of 26.19 points versus matched sham. The high-dose safety profile was broadly consistent with the 12 mg regimen. The high-dose regimen is approved in the EU and Japan and is under FDA review with a PDUFA date of April 3, 2026.
Biogen (Nasdaq: BIIB) announced the FDA granted Breakthrough Therapy Designation to litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE) on January 28, 2026. The designation reflects Phase 2 LILAC results published in The New England Journal of Medicine showing reduced CLE skin disease activity versus placebo. Biogen is advancing the AMETHYST Phase 3 study with a planned data readout in 2027.
The designation aims to expedite development and review for this first-in-class BDCA2-targeting monoclonal antibody, addressing a disease with no currently approved targeted therapies.
Biogen (NASDAQ: BIIB) and Eisai announced the FDA has accepted a supplemental BLA for LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector as a weekly 500 mg starting dose and granted Priority Review with a PDUFA action date of May 24, 2026. Trial sub-studies in the Phase 3 Clarity AD OLE showed once-weekly 500 mg SC achieved equivalent exposure to bi-weekly IV dosing and demonstrated similar clinical and biomarker benefits. SC administration had a safety profile comparable to IV with <2% systemic injection/infusion reactions and enables at-home initiation and maintenance dosing, potentially reducing infusion-related healthcare resources. LEQEMBI is approved in 53 countries and the SC 360 mg maintenance regimen was previously approved in the U.S. in August 2025.
Biogen (Nasdaq: BIIB) announced European Commission approval of a high dose regimen of SPINRAZA (nusinersen) for 5q spinal muscular atrophy on January 12, 2026. The regimen updates dosing to two 50 mg loading doses 14 days apart followed by 28 mg maintenance injections every four months, with a single 50 mg replacement for patients transitioning from 12 mg.
Approval is supported by DEVOTE Phase 2/3 data showing a CHOP-INTEND mean difference of 26.19 points (treatment-naïve infants) and HFMSE mean improvement of 1.8 points in transitioned patients; safety was generally consistent with the 12 mg regimen.
Stoke Therapeutics (Nasdaq: STOK) and collaborator Biogen (Nasdaq: BIIB) updated timelines for zorevunersen in Dravet syndrome. Completion of enrollment of 150 patients in the Phase 3 EMPEROR study is now expected in Q2 2026, with a topline data readout planned for mid-2027 and a rolling NDA initiation targeted in the first half of 2027. A recent multidisciplinary FDA meeting raised requests for additional information; discussions are ongoing and no immediate program changes were agreed. As of Jan 9, 2026, ~60 patients are in screening, ~60 randomized/dosed, and the company held $391.7M in cash and equivalents, expected to fund operations into 2028.