Biohaven (BHVN) Stock Plunges on FDA Setback – Will Its Biotech Pipeline Fuel a Comeback?
FDA Setback: Complete Response Letter Halts Lead Drug Ambitions Biohaven’s recent troubles center on VYGLXIA (troriluzole) – its lead drug candidate for spinocerebellar ataxia (SCA), a degenerative brain disorder that currently has no approved treatment reuters.com. On November 4, 2025, after market close, Biohaven announced that the FDA had issued a Complete Response Letter (CRL) rejecting the company’s New Drug Application. This CRL cited multiple concerns with Biohaven’s data: potential bias, design limitations, lack of pre-specification, and unmeasured confounding factors in the supporting studies stocktwits.com stocktwits.com. In simpler terms, the FDA was uneasy with how Biohaven ran and analyzed its