USFDAOct 22, 2026, 07:01 AM
Biohaven's Vyglxia SCA Drug Application Accepted for FDA Review
AI Summary
Biohaven Ltd. announced that the FDA has accepted its new drug application resubmission for Vyglxia (troriluzole) for the treatment of spinocerebeller ataxia (SCA). The FDA considers this resubmission a complete response to a previous action letter, with a user fee goal date set for Q1 2027. An advisory committee meeting is anticipated to gather external stakeholder input.
Key Highlights
- Biohaven's new drug application resubmission for Vyglxia (troriluzole) in SCA has been accepted for review by the FDA.
- The FDA considers the resubmission a complete response to the November 4, 2025 action letter.
- A user fee goal date has been assigned for the first quarter of 2027.
- The FDA plans to convene a Peripheral and Central Nervous System Advisory Committee meeting for input.
Price Impact
More from BHVN