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

Reviva Pharmaceuticals Holdings, Inc. (RVPH) 
Company Research Source: GlobeNewswire
Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year Initiation of RECOVER-2 registrational trial planned in H1 2026, subject to sufficient financing CUPERTINO, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced a regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding brilaroxazine, a Show less Read more
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