FDA Accepts Biohaven Vyglxia Resubmission for Spinocerebellar Ataxia With Q1 2027 Decision Date

Biohaven shares surged roughly 25-33% in premarket trading on October 22 after the FDA accepted the company's resubmitted new drug application for Vyglxia (troriluzole) in spinocerebellar ataxia, setting a user fee goal date in the first quarter of 2027. The FDA confirmed it considers the resubmission a complete response to the Complete Response Letter it issued on November 4, 2025, which had initially blocked approval.

The resubmission included new positive supportive analyses intended to address the agency's prior concerns. Before issuing a final decision, the FDA plans to convene a meeting of the Peripheral and Central Nervous System advisory committee, adding a formal public review step ahead of the PDUFA deadline.

Spinocerebellar ataxia is a rare, progressive neurological disease with limited treatment options, making Vyglxia a closely watched candidate in the rare disease space. A Q1 2027 approval, if granted, would give Biohaven its first commercial product in this indication.