Reviva Pharmaceuticals Receives FDA Recommendation for Second Phase 3 Trial of Brilaroxazine for Schizophrenia Treatment.

Reviva Pharmaceuticals announced that the FDA recommended a second Phase 3 trial, RECOVER-2, for its schizophrenia treatment Brilaroxazine before submitting a New Drug Application. The trial aims to generate additional efficacy and safety data, delaying Reviva's filing timeline to at least 2027. Brilaroxazine has shown promising results in previous studies, demonstrating broad-spectrum efficacy and a favorable safety profile. Reviva plans to initiate RECOVER-2 in the first half of 2026, subject to financing.