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%