FDA取消核心药物咨询委员会会议Biohaven(BHVN.US)盘前大涨超10%
Biohaven .Biohaven .(US:BHVN) 智通财经网·2025-08-22 12:37

Core Viewpoint - The FDA has canceled the advisory committee meeting for Biohaven's core drug, trorluzole, leading to a significant pre-market stock increase of 12.3% [1] Company Summary - Biohaven, a biotech company based in New Haven, Connecticut, received priority review status from the FDA for its new drug application (NDA) for trorluzole, aimed at treating spinocerebellar ataxia, a rare neurodegenerative disease [1] - The FDA extended the review period in May to assess additional materials submitted by Biohaven in response to agency requests [1] - On August 21, the FDA notified Biohaven that the advisory committee meeting was no longer necessary for the review process [1] - Biohaven is a spin-off of Biohaven Pharmaceutical, which was acquired by Pfizer in 2022, and the company expects the FDA to make a decision on its NDA by Q4 2025 [1]