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 (SCA) is a genetic neurological disorder that progressively damages coordination, movement, and balance, with no current treatments to stop its worsening. Vyglxia (troriluzole) is a modified version of riluzole that regulates glutamate, a brain chemical involved in nerve cell signaling. By balancing glutamate activity, Vyglxia may help stabilize nerve function and slow the decline in motor control for people with SCA.
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