The FDA has accepted Biohaven Ltd.'s resubmitted new drug application (NDA) for troriluzole (Vyglxia) to treat spinocerebellar ataxia (SCA). The agency considers the filing a complete response to its November 4, 2025 action letter and has set a user fee goal date in the first quarter of 2027. The FDA plans to convene an advisory committee meeting to gather external input on the drug's safety and efficacy. Biohaven Ltd. is a clinical-stage biopharmaceutical company focused on developing treatments for neurological disorders.
