- FDA accepted Biohaven's resubmitted NDA for Vyglxia (troriluzole) to treat spinocerebellar ataxia, per the company announcement reported Oct 22, 2026.
- The FDA action date is in Q1 2027.
- BHVN stock rose more than 30% early Thursday, Oct 22, 2026.
- A year before this news, the FDA refused to review troriluzole, citing issues with real-world evidence and external control studies. The resubmission includes new positive support analyses.
Quotes
“the Food and Drug Administration said it would review the company's embattled drug, troriluzole”