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) announced the FDA granted Breakthrough Therapy Designation to litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE) on January 28, 2026. The designation reflects Phase 2 LILAC results published in The New England Journal of Medicine showing reduced CLE skin disease activity versus placebo. Biogen is advancing the AMETHYST Phase 3 study with a planned data readout in 2027.
The designation aims to expedite development and review for this first-in-class BDCA2-targeting monoclonal antibody, addressing a disease with no currently approved targeted therapies.
Biogen (NASDAQ: BIIB) and Eisai announced the FDA has accepted a supplemental BLA for LEQEMBI IQLIK (lecanemab-irmb) subcutaneous autoinjector as a weekly 500 mg starting dose and granted Priority Review with a PDUFA action date of May 24, 2026. Trial sub-studies in the Phase 3 Clarity AD OLE showed once-weekly 500 mg SC achieved equivalent exposure to bi-weekly IV dosing and demonstrated similar clinical and biomarker benefits. SC administration had a safety profile comparable to IV with <2% systemic injection/infusion reactions and enables at-home initiation and maintenance dosing, potentially reducing infusion-related healthcare resources. LEQEMBI is approved in 53 countries and the SC 360 mg maintenance regimen was previously approved in the U.S. in August 2025.
Biogen (Nasdaq: BIIB) announced European Commission approval of a high dose regimen of SPINRAZA (nusinersen) for 5q spinal muscular atrophy on January 12, 2026. The regimen updates dosing to two 50 mg loading doses 14 days apart followed by 28 mg maintenance injections every four months, with a single 50 mg replacement for patients transitioning from 12 mg.
Approval is supported by DEVOTE Phase 2/3 data showing a CHOP-INTEND mean difference of 26.19 points (treatment-naïve infants) and HFMSE mean improvement of 1.8 points in transitioned patients; safety was generally consistent with the 12 mg regimen.
Stoke Therapeutics (Nasdaq: STOK) and collaborator Biogen (Nasdaq: BIIB) updated timelines for zorevunersen in Dravet syndrome. Completion of enrollment of 150 patients in the Phase 3 EMPEROR study is now expected in Q2 2026, with a topline data readout planned for mid-2027 and a rolling NDA initiation targeted in the first half of 2027. A recent multidisciplinary FDA meeting raised requests for additional information; discussions are ongoing and no immediate program changes were agreed. As of Jan 9, 2026, ~60 patients are in screening, ~60 randomized/dosed, and the company held $391.7M in cash and equivalents, expected to fund operations into 2028.
Biogen (Nasdaq: BIIB) reported JAMA Neurology publication of final Phase 3 VALOR and open‑label extension results for QALSODY (tofersen) in SOD1‑ALS with >3.5 years follow‑up.
Key findings: early initiation of QALSODY was associated with numerically slower decline in clinical function, breathing, and strength, plus a reduced risk of death or permanent ventilation. Sustained reductions in plasma neurofilament light chain (NfL) were observed, supporting impact on disease biology. QALSODY is approved in 44 countries and holds accelerated U.S. approval based on NfL reduction; continued U.S. approval may be contingent on confirmatory clinical benefit.
Biogen (Nasdaq: BIIB) and Stoke Therapeutics presented long-term data on zorevunersen for Dravet syndrome at the 2025 AES Annual Meeting on Dec 5, 2025. Phase 1/2a and open-label extension (OLE) data showed durable reductions in major motor seizures and increases in seizure-free days when added to standard anti-seizure medicines.
A propensity score weighted analysis versus the BUTTERFLY natural history cohort found statistically significant seizure reductions at six months after two 70 mg loading doses and sustained cognitive and behavioral improvements on Vineland-3 at 18 months with maintenance 45 mg dosing. EEG analyses showed dose-dependent decreases in abnormal activity correlated with lower seizure probability. Safety: 81 patients dosed, >800 doses given; most common drug-related TEAE was CSF protein elevation; three deaths reported and assessed as unrelated to treatment.
Biogen (NASDAQ:BIIB) and Eisai presented CTAD 2025 data showing continued LEQEMBI (lecanemab-irmb) maintenance treatment in early Alzheimer's disease may delay progression.
Key findings: time savings vs untreated ADNI decline — MCI to mild AD: overall +2.5 years, low-amyloid subgroup +6.0 years; MCI to moderate AD: overall +3.5 years, low-amyloid subgroup +8.3 years. A subcutaneous (SC) initiation program showed bioequivalence to IV (exposure ratio 104%, 90% CI 99.1%–109%) and low immunogenicity (ADA 1.4%).
Regulatory status: SC maintenance approved in US Aug 2025; sBLA rolling complete Nov 2025; Japan submission Nov 2025.
Biogen (Nasdaq: BIIB) and Eisai presented CTAD 2025 data showing that lecanemab (LEQEMBI) binds Aβ protofibrils (PF) measurable in CSF, supporting target engagement and a pharmacodynamic effect. In a Clarity AD CSF sub-cohort (n=410) total CSF PF rose +59% at 12 months with lecanemab vs +19% with placebo (difference p=0.0126). The treatment-associated PF mobilization correlated with a loss of the placebo correlation between PF changes and neurodegeneration/tau biomarkers, suggesting reduced PF-driven neurotoxicity. Safety data reiterated ARIA and ICH risks and recommended MRI monitoring and ApoE ε4 testing prior to treatment.
Stoke Therapeutics and Biogen (Nasdaq: BIIB) will present new clinical and EEG analyses for zorevunersen at the 2025 American Epilepsy Society Annual Meeting (Dec 5–9, Atlanta).
Presentations report up to four years of data from Phase 1/2a and ongoing open‑label extension (OLE) studies, including propensity‑weighted analyses and EEG findings in patients with Dravet syndrome. Zorevunersen is also being evaluated in the global pivotal Phase 3 EMPEROR study in children and adolescents with Dravet syndrome.
Sessions include one oral presentation (Dec 5) and multiple posters (Dec 6–8) covering seizure outcomes, seizure‑free days, quality of life, overall functioning, and electrophysiological EEG changes linked to seizure reductions.
Biogen (Nasdaq: BIIB) and Eisai announced completion of the rolling submission of an sBLA to the U.S. FDA on Nov 25, 2025 seeking approval of LEQEMBI IQLIK (lecanemab-irmb) as a 500 mg once-weekly subcutaneous starting dose after the FDA granted Fast Track Status. Company data show the 500 mg SC autoinjector (two 250 mg injections) achieved equivalent exposure to IV dosing every two weeks with similar clinical and biomarker effects and a safety profile comparable to IV administration (~<2% systemic injection/infusion reactions). If approved, IQLIK would allow at-home initiation and maintenance dosing and could reduce IV infusion resource needs; FDA will set a PDUFA action date upon sBLA acceptance.
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