Biohaven (BHVN) said Wednesday that the US Food and Drug Administration's Office of Neuroscience is extending the Prescription Drug User Fee Act, or PDUFA, date for troriluzole's new drug application for the treatment of spinocerebellar ataxia by three months.
The company said the extension is intended for a full review of its recent submissions to the FDA and no new concerns have been raised regarding its application. The FDA decision on the new drug application is now expected in Q4, said Biohaven.
Shares of Biohaven were down 11% in recent premarket activity Thursday.
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