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) and Eisai said the FDA extended the PDUFA action date for the sBLA for once‑weekly LEQEMBI IQLIK subcutaneous starting dose by three months to August 24, 2026 after the agency deemed submitted materials a major amendment.
The FDA has not identified approvability concerns to date; companies cite a comprehensive clinical data package and note prior FDA approval of subcutaneous maintenance dosing on August 26, 2025.
S&P Dow Jones Indices will revise the S&P SmallCap 600 effective before market open on May 14, 2026. Bright Horizons (BFAM) and Remitly Global (RELY) will be added; Tri Pointe Homes (TPH) and Apellis Pharmaceuticals (APLS) will be removed.
Removals follow announced acquisitions of Tri Pointe by Sumitomo Forestry and Apellis by Biogen, each described as expected to close soon pending final closing conditions.
Stoke Therapeutics (Nasdaq: STOK) reported Q1 2026 results and new 4-year Phase 1/2a OLE data for zorevunersen in Dravet syndrome. The OLE shows statistically significant improvements in cognition and behavior at 1–4 years and durable reductions in major motor seizures through four years.
As of March 31, 2026, cash, cash equivalents and marketable securities totaled $411.0 million, including $80.7 million from selective ATM sales, expected to fund operations into 2028. Phase 3 EMPEROR enrollment is nearing completion (~130 randomized of ~150; final randomization expected June 2026) to support a mid-2027 data readout and a planned rolling U.S. NDA starting in Q1 2027.
Jeito Capital (BIIB) announced the appointments of Elaine Caughey, MBA as Partner, Business Development and Investor Relations, and Sarah Shackelton, MPA as Partner, Talent, effective May 5, 2026. Both bring 20+–30+ years of life‑sciences experience across investment funds, pharma and biopharma.
Elaine will support BD, partnerships, acquisitions and U.S. expansion; Sarah will lead senior hiring, board building and talent strategy across the portfolio. The hires complement recent senior additions to strengthen Jeito’s operating and regulatory capabilities.
Stoke Therapeutics (Nasdaq: STOK) will host a webcast and conference call on Thursday, May 7, 2026 at 4:30 p.m. ET to discuss first-quarter 2026 business and financial updates.
The live webcast is available on the Investors & News section of Stoke's website, registration is required for analysts who wish to participate in Q&A, and a replay will be archived for at least 90 days.
Biogen (Nasdaq: BIIB) agreed April 20, 2026 to acquire TJ Biopharma’s exclusive felzartamab rights in the Greater China Region, consolidating worldwide development and commercialization of the CD38-directed antibody under one owner.
Deal terms include a $100 million upfront, up to $750 million in commercial milestones (total potential consideration up to $850 million), plus mid-single-digit to low-double-digit royalties. Biogen expects to record the upfront as an Acquired In‑Process R&D expense in Q2 2026 and will assume prior milestone and royalty obligations under the earlier MorphoSys licensing agreement. Felzartamab is in global Phase 3 studies; a China BLA for multiple myeloma submitted in Dec 2024 remains under review.
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.