Biohaven's ataxia drug resubmission accepted by FDA, shares surge 36%

Biohaven’s experimental drug troriluzole, being developed for spinocerebellar ataxia, was previously rejected by the FDA because the agency questioned the design of the registrational trial. The company has now submitted a revised application that addresses the earlier concerns.

The FDA has formally accepted the resubmission and set a decision deadline for the first quarter of 2027. An advisory committee meeting will be scheduled in the near term to review the data.

Following the filing, Biohaven’s shares rose as much as 36% on the news. Analysts note that the upcoming advisory committee will be a critical de-risking event for the drug’s path forward.