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) announced that the FDA granted Breakthrough Therapy Designation to investigational antisense oligonucleotide salanersen for spinal muscular atrophy (SMA). The designation is supported by Phase 1b data in children with suboptimal response to prior gene therapy, showing motor function gains and reduced neurofilament levels. Salanersen is dosed once yearly and was generally well-tolerated. A global Phase 3 program, including STELLAR-1, STELLAR-2 and SOLAR, is underway or preparing to recruit across presymptomatic infants, teens and adults with SMA.
Biogen (Nasdaq: BIIB) and UCB reported Phase 3 PHOENYCS GO data for investigational lupus therapy dapirolizumab pegol (DZP) at EULAR 2026. DZP plus standard of care was associated with sustained disease control during glucocorticoid tapering, reduced flare rates, improved immunological markers, and a generally favorable safety profile through Week 48.
Stoke Therapeutics (Nasdaq: STOK) will present at two investor conferences in June 2026. CEO Ian F. Smith and Chief Patient Officer Jason Hoitt will speak at the Jefferies Global Healthcare Conference on June 4 in New York and the Goldman Sachs 47th Annual Global Healthcare Conference on June 8 in Miami.
Live webcasts and archived replays will be available in the Investors & News section of Stoke Therapeutics’ website.
Biogen (Nasdaq:BIIB) reported topline Phase 2 CELIA results for diranersen (BIIB080) in early Alzheimer’s disease. CELIA did not meet its primary dose-response endpoint on CDR-SB at Week 76, but Biogen plans to advance diranersen to registrational development.
According to Biogen, pre-specified analyses showed slowing of clinical decline and robust, sustained reductions in CSF tau and tau PET across all doses, with greatest cognitive effect at the 60 mg every-24-weeks dose. Safety and tolerability were generally consistent with the prior Phase 1b study, though serious adverse events were more frequent at the highest dose.
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.