BIIB News

(NASDAQ:BIIB) Development Candidate Targeting IRAK4 Now Progressing Toward Clinical Development Development Candidate Targeting IRAK4 Now Progressing Toward Clinical Development

(NASDAQ:BIIB) BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB), today announced data from Phase 1/2a and open-label extension (OLE) studies of zorevunersen that support the potential for zorevunersen to be the first disease-modifying medicine for Dravet syndrome. Findings were presented at the 36th International Epil

(NASDAQ:BIIB) – Durable reductions in seizures and continuing improvements in cognition and behavior through 3 years in patients who continued to receive zorevunersen in the open-label extension studies –

(NASDAQ:BIIB) Subcutaneous delivery increases accessibility and introduces potential for at-home administration, following model of diabetes and GLP-1 drugs NEW YORK, Aug. 29, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced its approval of a subcutaneous formulation of...

(NASDAQ:BIIB) CHICAGO, Aug. 29, 2025 /PRNewswire/ -- The Alzheimer's Association welcomes today's U.S. Food and Drug Administration (FDA) action to approve weekly subcutaneous maintenance dosing of Leqembi® (lecanemab, Eisai/Biogen) for early Alzheimer's disease. With this approval, Leqembi IQLIK is...

(NASDAQ:BIIB) LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months

(NASDAQ:BIIB) LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6th, 2025, in the U.S. TOKYO...

– 3-year data from open-label extension (OLE) studies demonstrate the potential for disease modification with durable seizure reductions and improvements in cognition and behavior on top of standard anti-seizure medicines –

BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB), today announced presentations of new clinical data from studies of zorevunersen at the 36th International Epilepsy Congress (IEC), taking place August 30 – September 3, 2025 in Lisbon, Portugal. Zorevunersen, an investigational antisense oligonucleotide,

TOKYO and CAMBRIDGE, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the anti-amyloid beta (Aβ) monoclonal antibody “LEQEMBI®” has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025. LEQEMBI received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer’s disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD ( collectively referred to as early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology.1 Germany and Austria will mark the first launches in the EU.

– Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period –

UCB and Biogen's lupus candidate showed strong Phase 3 results, including fatigue improvement and higher remission versus standard care.

Biogen beat Q1 earnings and revenue estimates, raised rare disease drug sales, and cut its 2025 EPS guidance due to a $165 million collaboration payment.

Leqembi gains European approval after CHMP reversal, despite safety concerns tied to brain swelling and bleeding in Alzheimer's treatment.

Eli Lilly's donanemab faces a setback as EMA's CHMP issues a negative opinion. Analysts expect Lilly to appeal, citing past reversals in similar cases.

Novartis' OAV101 IT gene therapy showed positive results in Phase 3 trials for SMA, with data supporting its potential as a treatment option.

NICE has upheld its decision not to recommend Alzheimer's treatments donanemab and lecanemab for NHS use, citing high costs and limited benefit. Stakeholders can submit feedback until March 27, 2025, before final recommendations are issued.