for spinocerebellar ataxia (SCA)
FDA issued a Complete Response Letter for the troriluzole (Vyglxia) NDA in spinocerebellar ataxia on November 5, 2025. The original PDUFA was August 2025; FDA extended three months to November before issuing the CRL. Specific deficiency details would require sponsor 8-K review.
Spinocerebellar ataxia is a progressive genetic disease that damages the brain's cerebellum, leading to a gradual loss of coordination and balance. Vyglxia is a drug designed to modulate glutamate, a key chemical messenger in the brain that can become overactive and contribute to nerve cell dysfunction. By calming this signaling, the drug could potentially help slow the progression of symptoms in this currently untreatable condition.
The primary purpose of this study was to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in participants with spinocerebellar ataxia (SCA).
Source: ClinicalTrials.gov