What's Going On With Biogen Stock Thursday

Biogen Inc BIIB shares were flat in Thursday's after-hours session after falling marginally by 0.31% to $284.99 during regular trading.

The U.S. FDA announced late Thursday the agency has granted traditional approval to Leqembi (lecanemab) to Eisai Inc. for treating adult patients with Alzheimer's Disease (AD) following a confirmatory trial that verified its clinical benefit.

Eisai and Biogen have collaborated on the joint development and commercialization of AD treatments since 2014.

Eisai serves as the lead of lecanemab development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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What Else?

In a Thursday press release, the FDA said Leqembi is the first amyloid beta-directed antibody to transition from accelerated approval to traditional approval for Alzheimer's treatment. It reduces amyloid plaques in the brain, a key feature of the disease. Leqembi's efficacy was evaluated in a Phase 3 trial involving 1,795 patients.

The FDA, meanwhile, says common side effects include headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA). 

Leqembi is contraindicated in patients with hypersensitivity to its components. The agency warned use with anticoagulants carries a risk of intracerebral hemorrhage.

The FDA also says Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stages of Alzheimer's.

According to data from Benzinga Pro, BIIB has a 52-week high of $319.76 and a 52-week low of $193.65.