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

Biohaven

11/02/2025 14:25

** 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))