BRIEF—FDA drops need for AdCom on Biohaven’s troriluzole
Shares in Biohaven moved up about 7% on Friday after the company provided an update with respect to its New Drug Application (NDA) for troriluzole for the treatment of adult patients with spinocerebellar ataxia (SCA), in a filing with the Securities and Exchange Commission (SEC).
As previously disclosed, in May 2025, the Division of Neurology 1 within the Office of Neuroscience of the Food and Drug Administration (FDA) informed the company that it was extending the Prescription Drug User Free Act (PDUFA) date for the troriluzole NDA by three months to provide time for a full review of the company’s recent submissions related to information requests from the FDA.
At that time, the Division also informed Biohaven that it was planning to hold an advisory committee meeting to discuss the application.
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