FDA cancels advisory committee meeting for Biohaven's troriluzole NDA; decision still Q4 2025

Biohaven Ltd.

FDA informed Biohaven on Aug 21, 2025 that an advisory committee meeting is no longer needed for troriluzole NDA review.
Previously, FDA had extended PDUFA by 3 months (to Q4 2025) and planned an AdComm.
Troriluzole is for treatment of adult Spinocerebellar Ataxia (SCA).
FDA's expected decision remains during Q4 2025.

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