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) 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.
Stoke Therapeutics (Nasdaq: STOK) and Biogen (Nasdaq: BIIB) are presenting new clinical data for zorevunersen, an investigational antisense oligonucleotide for Dravet syndrome, at the 16th European Epilepsy Congress in Athens, Sept. 5–9, 2026. The presentations include the first 4‑year results from ongoing Phase 1/2a open‑label extension (OLE) studies in highly refractory patients aged 2–18 years (N=81).
According to Stoke Therapeutics, 93% (75/81) of patients entered OLEs and 77% (58/75) remained on treatment at the 4‑year cutoff, with more than 930 doses given as of July 31, 2026. Zorevunersen showed sustained improvements in cognition and behavior, durable seizure reductions, and a generally well‑tolerated safety profile. Elevated cerebrospinal fluid (CSF) protein lab values occurred in about 94% of patients, with 59% classified as treatment‑emergent adverse events, but no serious or severe clinical manifestations or hydrocephalus were reported. Zorevunersen has orphan drug and Breakthrough Therapy designations and is being studied in the global pivotal Phase 3 EMPEROR trial, with results anticipated in the third quarter of 2027.
Biogen (Nasdaq: BIIB) and Eisai announced that once-weekly subcutaneous lecanemab‑irmb autoinjector LEQEMBI IQLIK is now available in the U.S. for initiation therapy in adults with early Alzheimer’s disease, including mild cognitive impairment and mild dementia due to Alzheimer’s.
LEQEMBI IQLIK delivers 500 mg once weekly as two consecutive 250 mg injections for initiation and may be used for 360 mg once-weekly maintenance after 18 months of IV or subcutaneous treatment. Patients can receive LEQEMBI via IV infusion or subcutaneous injection throughout treatment and may switch between routes, enabling at-home dosing, reduced clinic visits, and potential lowering of infusion-related healthcare resource use. According to the companies, patient and provider support includes an Instructions for Use video, IQLIK Welcome Kit, the LEQEMBI Companion app, specialty pharmacy support, and a patient assistance program providing no-cost drug for certain eligible uninsured patients.
Biogen (Nasdaq: BIIB) has completed the acquisition of RayThera, a privately held biotechnology company focused on discovering and developing small-molecule therapies in immunology. According to Biogen, the deal strengthens its growing immunology portfolio by adding multiple assets with potential to treat immune-mediated conditions across a range of indications.
The lead RayThera program entered Phase 1 development in July 2026, aligning with Biogen’s strategy to expand and diversify its pipeline for long-term growth. Biogen highlights this acquisition as an example of execution on its open innovation model and as part of its continued investment in immunology as a strategic growth area.
Stoke Therapeutics (Nasdaq: STOK) announced that CEO Ian F. Smith and Chief Patient Officer Jason Hoitt will present at the Canaccord Genuity 46th Annual Growth Conference on Wednesday, August 12, 2026 at 11:00 a.m. ET. A live webcast and archived replay will be available in the Investors & News section of Stoke’s website.
The company is developing its lead investigational antisense oligonucleotide, zorevunersen, a potential disease-modifying treatment for Dravet syndrome, currently in a Phase 3 study and partnered with Biogen (Nasdaq: BIIB) under a regional commercialization collaboration.