09:05 AM EDT, 04/26/2024 (MT Newswires) -- (Updates with more details on the approval in the story body.)

Pfizer ( PFE ) said Friday that the US Food and Drug Administration has approved Beqvez, its drug that seeks to treat adults with moderate to severe hemophilia B who meet certain requirements.

The approval was based on a late-stage study in which the gene therapy Beqvez significantly reduced bleeding in 60% of the patients, the company said.

Pfizer ( PFE ) said it is launching a warranty program that is based on the durability of patient response to Beqvez treatment.

Beqvez is also currently under review with the European Medicines Agency, Pfizer ( PFE ) said.

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