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 reported real‑world US data showing high long‑term persistence with intravenous LEQEMBI (lecanemab). In a claims analysis of 10,763 treated individuals (mean age 73.8), 78.4% remained on therapy at 18 months, 71.7% at 20 months, and 67.3% at 24 months.
The analysis used PurpleLab CLEAR Claims data (Jan 6, 2023–Nov 30, 2025); mean follow‑up was 350.9 days and mean dosing interval was 16.4 days (median 14 days).
Biogen (Nasdaq: BIIB) will present late-breaking Phase 2 AMETHYST Part A data on litifilimab in cutaneous lupus erythematosus (CLE) at the 2026 American Academy of Dermatology Annual Meeting, March 27-31.
Presentations include a late-breaking oral on March 28 and posters on CLASI and CLA-IGA-R measures. Litifilimab, a BDCA2-targeting monoclonal antibody, recently received FDA Breakthrough Therapy Designation for CLE, supported by AMETHYST Part A and prior LILAC results. Phase 3 is on track with a planned data readout in 2027.
Biogen (Nasdaq: BIIB) presented Phase 1b data showing salanersen, an investigational once-yearly antisense oligonucleotide for spinal muscular atrophy (SMA), was generally well tolerated and associated with functional improvement in 24 children previously treated with gene therapy.
Key findings: sustained 75% reductions in neurofilament light chain at six months for participants with elevated baseline NfL, 12 of 24 achieved new WHO motor milestones, and all maintained or improved baseline milestones. Biogen also launched a global Phase 3 program (STELLAR-1, STELLAR-2, SOLAR) with planned initiations in Q2–Q3 2026.
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.