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.
Stoke Therapeutics (Nasdaq: STOK) announced that CEO Ian F. Smith will present at the 25th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, 2026 at 3:00 p.m. ET. A live webcast and archived replay will be available in the Investors & News section of Stoke's website.
Stoke Therapeutics (Nasdaq: STOK) appointed Clare Kahn, Ph.D. to its Board of Directors on April 7, 2026. Dr. Kahn brings 30+ years of regulatory strategy and drug development experience in rare genetic diseases, including roles at X-VAX, Pfizer, and GlaxoSmithKline.
Her addition is positioned to support advancement of zorevunersen as the company progresses its Phase 3 study in Dravet syndrome.
Biogen (Nasdaq: BIIB) agreed to acquire Apellis for $41.00 per share in cash (≈$5.6 billion) plus a contingent value right (CVR) tied to SYFOVRE® sales, with closing expected Q2 2026.
The deal adds two commercial complement medicines with combined 2025 net sales of $689 million, projected to grow in the mid-to-high teens at least through 2028, and is expected to be accretive to non-GAAP EPS starting in 2027.
Biogen (Nasdaq: BIIB) announced FDA approval of a High Dose Regimen of SPINRAZA (nusinersen) for spinal muscular atrophy on March 30, 2026. The regimen uses 50 mg/5 mL loading doses and 28 mg/5 mL maintenance every four months and will be available in the United States in the coming weeks.
The approval is based on the Phase 2/3 DEVOTE study showing a mean CHOP-INTEND improvement of 26.19 points versus a matched sham group (p<0.0001). High Dose SPINRAZA is also approved in the EU, Switzerland, and Japan.
Biogen (Nasdaq: BIIB) reported positive Phase 2 AMETHYST Part A results for litifilimab in cutaneous lupus erythematosus presented March 28, 2026 at AAD. The trial met its primary endpoint: an 11.8% absolute higher rate of clear/almost clear skin (14.7% vs 2.9%) at Week 16.
Secondary measures showed larger CLASI-50 and CLASI-70 improvements and a safety profile consistent with prior studies; Phase 3 is ongoing and blinded.
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.