FDA accepts Biohaven's resubmitted Vyglxia (troriluzole) NDA for spinocerebellar ataxia

On 22 October 2026 Biohaven said the US FDA had accepted for review its resubmitted new drug application (NDA) for Vyglxia (troriluzole) in spinocerebellar ataxia (SCA), a rare inherited disorder that progressively impairs movement, balance and speech.

The FDA considers the resubmission a complete response to the complete response letter (a formal rejection outlining deficiencies) Biohaven received in November 2025, and has assigned a user fee goal date in the first quarter of 2027. The agency plans to hold an advisory committee meeting of external experts to discuss the application, a sign the case is one of the more complex ones. The resubmission includes new positive supportive analyses. If approved, Vyglxia would be the first product approved in Biohaven's pipeline.

Read more: Biohaven SEC Form 8-K, 22 October 2026