Reviva Announces Regulatory Update Regarding the Development of Brilaroxazine for the Treatment of Schizophrenia

Core Insights - The FDA has recommended a second Phase 3 trial for brilaroxazine to generate additional efficacy and safety data before the NDA submission for schizophrenia treatment [1][2] - Reviva Pharmaceuticals plans to initiate the RECOVER-2 registrational trial in the first half of 2026, contingent on sufficient financing [1][2][3] - The current data package for brilaroxazine indicates a long-term safety profile, broad-spectrum clinical activity, and favorable adherence for once-daily administration over up to one year [1][3][6] Company Overview - Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [4] - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [4] Clinical Data - Brilaroxazine has shown broad-spectrum efficacy in major symptom domains of schizophrenia, including negative symptoms, in 790 subjects from completed clinical trials [6] - The safety profile of brilaroxazine is generally well-tolerated, observed in over 900 subjects treated to date [6]