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 (STOK) reported a third-quarter net loss of $73.6 million and updated progress on its clinical development programs. Revenue rose to $11.3 million from $10.6 million a year earlier, while the loss widened from $38.3 million. Cash, cash equivalents and marketable securities totaled $358.8 million at September 30, 2026; Stoke expects funding into early 2028.
In the Phase 3 EMPEROR study of investigational Dravet syndrome treatment zorevunersen, approximately 110 patients reached Week 28 and approximately 20 reached Week 52, with no treatment discontinuations. Stoke anticipates data in Q3 2027 and plans a U.S. New Drug Application in H2 2027. Following FDA discussions, cognition and behavior will be evaluated using four Vineland-3 assessment subdomains. Third-cohort dosing is underway in the Phase 1 STK-002 study for autosomal dominant optic atrophy, with initial safety and efficacy data anticipated in H1 2027.
Biogen (BIIB) will present Alzheimer’s disease portfolio data at the CTAD conference in Boston on November 16–19, 2026. A diranersen symposium will feature 96-week extension efficacy and safety data from the Phase 2 CELIA study, alongside additional 76-week biomarker and clinical analyses.
Lecanemab presentations will include initial five-year Clarity AD open-label extension findings on clinical outcomes, disease progression and safety. A separate session will cover three-year LEADER real-world evidence, including maintenance treatment and experience with at-home subcutaneous administration. The announcement schedules these presentations but does not disclose their results.
Stoke Therapeutics (Nasdaq: STOK) will host a webcast and conference call on October 29, 2026, to discuss third-quarter business and financial updates. Management will speak at 4:30 p.m. ET. The webcast will be available through the Investors & News section of Stoke’s website, with an archived replay available for at least 90 days following the event.
Biogen (BIIB) will present new 76-week EMPAVELI kidney-disease data at American Society of Nephrology Kidney Week, October 22–25, 2026.
Biogen reports sustained reductions in protein in urine and continued stabilization of estimated kidney filtration, with a consistent long-term safety profile, in C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Presentations include a pediatric subgroup analysis. The FDA recently expanded EMPAVELI’s indication to include reducing kidney-function loss in adults and adolescents aged 12 years and older with these diseases.
Investigational felzartamab is being studied in three Phase 3 trials covering antibody-mediated rejection in adult kidney transplant recipients, IgA nephropathy and primary membranous nephropathy, plus a Phase 2 microvascular inflammation trial. Biogen expects TRANSCEND rejection-study data in H1 2027.
Stoke Therapeutics (STOK) completed an FDA meeting on its planned U.S. application for zorevunersen, an investigational treatment for Dravet syndrome. Following the discussion, Stoke plans to assess cognition and behavior in Phase 3 EMPEROR using four prespecified Vineland-3 subdomains: expressive communication, receptive communication, interpersonal relationships and personal skills.
Stoke plans to submit data throughout the first half of 2027, anticipates a Phase 3 readout in the third quarter of 2027, and plans to complete its New Drug Application in the second half of 2027, supporting potential U.S. approval and launch in early 2028. EMPEROR compares zorevunersen with a sham procedure over 52 weeks. Its primary endpoint measures seizure-frequency change at Week 28; secondary endpoints assess durability and adaptive functioning at Week 52. All study data will be analyzed at Week 52.
Biogen (BIIB) reported 52-week Phase 2 results showing continued improvement with litifilimab in cutaneous lupus erythematosus, an autoimmune skin disease. Among participants treated from the start, 27.2% achieved clear or almost clear skin at Week 52 versus 19.0% at Week 24. A reduction of at least 70% in skin disease activity occurred in 28.8%, versus 21.7% at Week 24.
Participants switching from placebo at Week 24 improved as early as four weeks later; 33.7% achieved clear or almost clear skin at Week 52. No new safety signals emerged, though serious adverse events occurred in 3.4% (3/88) during extended treatment. The Phase 2 study evaluated 93 adults whose antimalarial treatment was ineffective or intolerable. Biogen expects Phase 3 results in the first half of 2027. Litifilimab received FDA Breakthrough Therapy Designation for CLE in January 2026 and remains investigational.
Stoke Therapeutics (STOK) appointed Bo Cumbo to its board on September 23, 2026, as director Edward Kaye retired. Kaye had served on the board since 2017 and was Stoke’s chief executive officer until March 2025. He will continue to advise the board through the transition. Cumbo has more than 30 years of biopharmaceutical experience and has been president and chief executive officer of Solid Biosciences since 2022.
Cumbo previously served as Sarepta Therapeutics’ chief commercial officer, where he worked on launches of treatments for Duchenne muscular dystrophy. Stoke is evaluating zorevunersen, an investigational treatment for Dravet syndrome, in a Phase 3 study. Stoke’s chief executive said the company is preparing for a potential FDA approval in early 2028. Zorevunersen’s safety and efficacy have not been evaluated by a regulatory authority. Stoke collaborates with Biogen (BIIB) on its development and commercialization.
Biogen (BIIB) reported Phase 3 VALIANT adolescent subgroup results for EMPAVELI (pegcetacoplan) in C3 glomerulopathy (C3G) and primary IC-MPGN, showing reduced proteinuria and stabilized kidney function versus placebo, with data published in the Clinical Journal of the American Society of Nephrology.
Among 55 adolescents aged 12–17 years at Week 26, EMPAVELI achieved a 75% relative reduction in proteinuria versus placebo (95% CI: 59%–84%; nominal p<0.001), with effects seen from Week 4 through Week 26. In this cohort, 71% of EMPAVELI-treated adolescents reached at least a 50% proteinuria reduction versus 4% on placebo, and 57% achieved both stable kidney function and ≥50% proteinuria reduction versus 4% on placebo. EMPAVELI was reported as well tolerated in adolescents, with a safety profile consistent with the overall VALIANT population.
The publication follows an FDA label expansion making EMPAVELI the first and only approved therapy in the United States to reduce both proteinuria and loss of kidney function in adults and adolescents aged ≥12 years with C3G or primary IC-MPGN.
Stoke Therapeutics (STOK) and Biogen (BIIB) reported long-term clinical data for investigational Dravet syndrome therapy zorevunersen from Phase 1/2a and open-label extension studies, and detailed the ongoing global Phase 3 EMPEROR trial.
Four-year extension data showed durable reductions in seizures and statistically significant improvements in cognition and behavior at 1, 2, 3 and 4 years versus open-label baseline. Exploratory analyses indicated substantial reductions in the most severe seizure types through 3 years and improved quality of life through 28 months. Zorevunersen was generally well tolerated over more than 930 administered doses, with some patients treated for more than 5 years; elevated cerebrospinal fluid protein was common but without serious clinical manifestations or hydrocephalus. The EMPEROR study has completed enrollment in the United States, United Kingdom, Japan and Europe, with 162 patients in the primary analysis population and 34 in Europe, and a Phase 3 data readout is anticipated in Q3 2027 to complete a planned rolling U.S. NDA submission in the second half of 2027.
Stoke Therapeutics (STOK) will present at the Cantor Global Healthcare Conference on Wednesday, September 9, 2026, at 1:00 p.m. ET. CEO Ian F. Smith and Chief Patient Officer Jason Hoitt will speak, and a live webcast plus archived replay will be available in the Investors & News section of Stoke’s website.