FDA accepts Biohaven's Vyglxia resubmission for review in spinocerebellar ataxia
BHVN•The FDA accepted Biohaven's Vyglxia (troriluzole) resubmission for review and set a user fee goal date in the first quarter of 2027.
1. Resubmission accepted
Biohaven announced on Oct. 22, 2026, that the FDA accepted its Vyglxia (troriluzole) application resubmission for review in spinocerebellar ataxia. The agency deemed it a complete response to its Nov. 4, 2025, action letter. The resubmission included new positive supportive analyses previously submitted to the FDA. The Peripheral and Central Nervous System Advisory Committee will review the application; the meeting date will be announced soon.
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