Release Details

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Biogen Stock Trading Halted Today; FDA Advisory Committee to Review Supplemental Biologics License Application for the Potential Traditional Approval of LEQEMBI in Early Alzheimer’s Disease

June 9, 2023

Cambridge, Mass. – JUNE 9, 2023Biogen Inc. (Nasdaq: BIIB) announced today that NASDAQ has halted trading of the company’s common stock.

 The U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee is meeting today to review the LEQEMBI™ (lecanemab-irmb) supplemental Biologics License Application (sBLA) for the potential traditional approval of LEQEMBI in Early Alzheimer’s disease.

 The Advisory Committee meeting is scheduled for 10:00 AM ET. The briefing materials can be found on the FDA website HERE.

 The Prescription Drug User Fee Act date for completion of the review of the sBLA for LEQEMBI is July 6, 2023.

 About Biogen

Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

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