FDA Skips Advisory Meeting on Biohaven Troriluzole SCA Drug

Biohaven announced that the FDA will no longer hold an advisory committee meeting to review its New Drug Application for troriluzole, a potential treatment for adult patients with spinocerebellar ataxia, a rare neurodegenerative disorder. The FDA had previously extended its review timeline by three months to assess additional information submitted by Biohaven and initially planned to convene the advisory committee. Despite the cancellation of the advisory meeting, the FDA is still expected to make a regulatory decision by the fourth quarter of 2025. Approval of troriluzole would mark the first FDA-approved treatment for spinocerebellar ataxia, a condition characterized by progressive loss of motor control and cerebellar atrophy. Biohaven’s shares rose following the announcement, reflecting investor optimism. The company also reported higher-than-expected research and development expenses for the second quarter, although these costs were significantly lower than the previous year.