BUZZ-Biohaven rises as FDA grants priority review status for brain disorder drug

Reuters
11 Feb
BUZZ-Biohaven rises as FDA grants priority review status for brain disorder drug

** Drug developer Biohaven's BHVN.N shares rise 8.50% to $41.50 premarket

** Co says the FDA on Tuesday granted priority review status to the firm's marketing application for the drug troriluzole to treat spinocerebellar ataxia $(SCA)$

** 'Priority review' status is assigned to drugs that offer a significant improvement over other available treatments for a specific disorder or would provide a treatment option where none exists

** Co's application to the FDA is based on data from a real-world study in which troriluzole helped improve symptoms of the disease over three years

** BHVN's drug also slowed progression of the disease by 50%-70% vs placebo, according to the data

** William Blair analysts said this rate of decline represents a delay of 1.5-2.2 years in disease progression for SCA patients

** SCA is a rare, genetic, life-threatening neurodegenerative disease, which affects a part of the brain vital to coordination of physical movement

** Co expects to receive a decision from the FDA during Q3 2025

** In the last 12 months, stock has fallen 20.54%

(Reporting by Siddhi Mahatole)

((siddhiprabhanjan.mahatole@thomsonreuters.com))

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