Biohaven Announces FDA Acceptance of Vyglxia NDA Resubmission for SCA

Biohaven Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for Vyglxia (troriluzole) for the treatment of spinocerebellar ataxia (SCA). The FDA deemed the resubmission, which included new positive supportive analyses, a complete response to its previous action letter from November 2025.

Key Details

• Regulatory Event: The FDA has accepted the NDA resubmission for Vyglxia (troriluzole) for review, targeting the SCA indication.
• Timeline: A PDUFA (Prescription Drug User Fee Act) goal date for a decision has been set for the first quarter of 2027.
• Next Steps: The FDA intends to convene a meeting of the Peripheral and Central Nervous System Advisory Committee to review the application.