FDA Accepts Biohaven's Resubmitted Vyglxia Application for Rare Disease SCA, Sets Q1 2027 Goal Date
Biohaven disclosed in a Form 8-K filing dated October 22, 2026, that the U.S. Food and Drug Administration (FDA) has accepted for review its resubmitted new drug application for Vyglxia (troriluzole) for the treatment of spinocerebellar ataxia (SCA). The FDA assigned a user fee goal date in the first quarter of 2027 and plans to convene its Peripheral and Central Nervous System Advisory Committee to review the application, with the meeting date to be announced in the near term.
The FDA considers the resubmission a complete response to the complete response letter it issued on November 4, 2025. Biohaven said the resubmission included new positive supportive analyses, though the filing did not describe the analyses or report trial data. The company noted that the goal date does not guarantee FDA action or approval, that the review may be extended, and that the agency could request more information or issue another complete response letter.
Spinocerebellar ataxia is a rare, life-threatening inherited neurodegenerative disease characterized by progressive loss of voluntary motor control and atrophy of the cerebellum and brainstem, affecting balance, coordination, walking and speech. Troriluzole is an investigational oral drug and has not been approved for any indication in the United States. Biohaven shares rose about 39% in premarket trading on October 22 to $16.35 following the announcement, according to Dow Jones Newswires.
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监管局 FDA 总部入口（FDA 官方图，公共领域）
