FDA accepts Biohaven’s resubmission for Vyglxia
The FDA has accepted Biohaven’s resubmitted application for Vyglxia, a drug targeting spinocerebellar ataxia, and will hold an advisory committee meeting.
23 Oct 2026 0 reads Compiled with AI
The U.S. Food and Drug Administration has opened a review of Biohaven’s resubmitted New Drug Application for Vyglxia, a drug that the company says may help people with spinocerebellar ataxia (SCA). The acceptance means the agency has taken the application back into consideration after a rejection last November.
The resubmission includes new supportive analyses that the FDA says address the concerns raised in its November 4, 2025 action letter. Biohaven notes that the data suggest the drug could slow disease progression by up to 70%, and the agency has called the submission a complete response.
The FDA plans to convene a meeting of its Peripheral & Central Nervous System Advisory Committee to get input from external experts. The meeting date is to be announced soon, but the agency expects to issue a decision in the first quarter of next year.
Biohaven, a Connecticut‑based developer that was spun off from Pfizer in 2022, has pursued Vyglxia through several rare‑disease trials. The drug was previously rejected for design concerns, but the company has since filed a second version with updated data, which caused its shares to jump about 25% after the filing.