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 announced that the FDA has approved a supplemental Biologics License Application for LEQEMBI IQLIK (lecanemab-irmb), a once‑weekly 500 mg subcutaneous autoinjector regimen as an initiation dose for adults with early Alzheimer’s disease (mild cognitive impairment or mild dementia).
The regimen uses two 250 mg injections (~15 seconds each) and may transition after 18 months of IV or SC therapy to 360 mg weekly maintenance. Clinical data from Clarity AD long‑term extension sub‑studies showed SC exposure equivalent to IV, supporting similar efficacy and amyloid removal, with an overall safety profile generally comparable to IV and mostly localized injection reactions.
LEQEMBI IQLIK is the only at‑home administration option across the full treatment journey in the U.S., with U.S. availability for initiation dosing expected in late August 2026 via specialty pharmacies, alongside support from the LEQEMBI Companion program and Eisai’s Patient Assistance Program.
Stoke Therapeutics (Nasdaq: STOK) announced the appointment of Thomas McCauley, Ph.D., as Chief Scientific Officer. McCauley brings more than 25 years of experience building R&D organizations, advancing novel technology platforms, and translating early research into approved medicines for severe and rare diseases, including genetic medicines at Shire.
He will lead Stoke’s scientific strategy and leverage its proprietary RNA medicines platform to expand and advance the pipeline, including the lead investigational medicine zorevunersen, which is in late-stage development as a potential first-in-class, disease-modifying treatment for Dravet syndrome. McCauley previously held senior scientific leadership roles at Neptune Bio, Omega Therapeutics, Macrolide Pharmaceuticals, Translate Bio, and others.
Biogen (Nasdaq: BIIB) and Eisai reported new clinical and real‑world data at AAIC 2026 showing that the once‑weekly 500 mg LEQEMBI (lecanemab) subcutaneous autoinjector (SC‑AI) achieved drug exposure bioequivalent to the approved IV initiation regimen (10 mg/kg every two weeks), with an exposure ratio of 104% (90% CI: 99.1%–109%).
The companies said amyloid removal, clinical efficacy (CDR‑SB) and ARIA‑E incidence were driven by exposure, not administration route, supporting expectations of comparable efficacy and safety across body‑weight groups and enabling a fixed‑dose regimen. Safety for SC‑AI was generally aligned with IV, with low anti‑drug antibody incidence (1.4%) and no neutralizing antibodies observed.
Early real‑world and clinical‑practice data from two U.S. centers showed slower cognitive decline versus a matched natural‑history cohort, high patient and care‑partner satisfaction (75%–97%), strong convenience scores (83%–97%), and 92%–100% willingness to recommend treatment. Subcutaneous initiation and maintenance may allow flexible switching between IV and SC dosing and at‑home administration, pending FDA approval.
Stoke Therapeutics (Nasdaq:BIIB) completed enrollment of 162 patients in the global Phase 3 EMPEROR study of investigational Dravet syndrome therapy zorevunersen. About 50 patients have reached the 28-week primary endpoint time point and no patients have discontinued treatment.
Stoke plans to begin a rolling U.S. NDA submission in Q1 2027, with Phase 3 data expected in Q3 2027 to support completion of the NDA in the second half of 2027 and a potential U.S. launch by early 2028.
Biogen (Nasdaq:BIIB) will present new data from its Alzheimer’s disease portfolio at AAIC 2026, July 12–15 in London.
Key sessions include Phase 2 CELIA clinical, biomarker and safety data for tau‑targeting ASO diranersen, and multiple presentations on lecanemab/LEQEMBI, including subcutaneous use and three‑year LEADER real‑world evidence.
Biogen (Nasdaq: BIIB) agreed to acquire private biotech RayThera for up to $1 billion, combining an upfront payment with clinical and regulatory milestone payments. RayThera adds multiple anti-inflammatory immunology assets, with the lead candidate expected to enter Phase 1 in early Q3 2026.
Closing is targeted for Q3 2026, subject to customary regulatory approvals. After completion, Biogen plans to lead development, manufacturing and global commercialization of RayThera’s portfolio, aiming to expand into additional immune-mediated indications.
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.