William Blair Downgrades Biohaven Pharmaceutical Holding (BHVN) to Market Perform
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FDA Issues Complete Response Letter for Biohaven's VYGLXIA (troriluzole) New Drug Application for Spinocerebellar Ataxia
November 4, 2025 8:06 PM ESTThe troriluzole clinical development program encompassed the first industry clinical trials to generate data showing therapeutic potential in patients with spinocerebellar ataxia (SCA), a rare genetic, inherited, life-threatening neurodegenerative disease with no treatment options.
Compelling data from troriluzole's new drug application (NDA) included: a 3-year real-world evidence study (Study 206-RWE) showing slowing of SCA disease progression by 50-70% in troriluzole-treated patients compared to matched untreated external controls; > 50% risk reduction in AEs of falls in troriluzole-treated subjects compared to placebo from the safety analysis of the 1-year, double-blind, placebo... More
