FDA accepts Biohaven's resubmitted NDA for troriluzole in spinocerebellar ataxia

Biohaven Ltd. disclosed on October 22, 2026 that it had provided an update on the spinocerebellar ataxia (SCA) program.¹

The FDA has informed Biohaven that the company's new drug application resubmission for Vyglxia (troriluzole) in SCA has been accepted for review.¹ The resubmission included new positive supportive analyses.¹

The FDA communicated that it considers the resubmission a complete response to the November 4, 2025 action letter, and has assigned a user fee goal date in the first quarter of 2027.¹ The FDA also plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee to obtain input from external stakeholders, with the anticipated meeting date to be announced in the near term.¹

The filing included standard cautionary language noting that the PDUFA target action date is a goal and does not assure that the FDA will act by that date or approve the NDA.¹ It also noted that the FDA may extend the review period, including if it determines that information submitted during the review constitutes a major amendment, may request additional information, or may issue a complete response letter.¹

Biohaven emphasized that troriluzole is an investigational drug and has not been approved for any indication in the United States.¹