Business
Reviva Reports Full Year 2025 Financial Results and Recent Business Highlights
- Written FDA recommendations include a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for
About this update from Reviva Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"- Written FDA recommendations include a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for schizophrenia – - Current data package highlights well-tolerated long-term safety profile, broad-spectrum clinical activity, and favorable adherence for once daily brilaroxazine up to one year - - Initiation of RECOVER-2 registrational trial planned in mid-2026 - CUPERTINO, Calif., March 30, 2026 (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 reported financial results for the full year ended December 31, 2025 and summarized recent business highlights. “With clear and actionable guidance from the Food and Drug Administration (FDA), we are advancing toward initiating our second registrational phase 3 trial (RECOVER-2) and preparing the data package for supporting a New Drug Application (NDA) for brilaroxazine for the treatment of schizophrenia,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Our strong clinical package, including durable efficacy and consistent safety and tolerability from acute through stable schizophrenia up to one year, and favorable treatment adherence with once-daily dosing, underscores the potential of brilaroxazine to address meaningful unmet needs for patients with schizophrenia. With plans to initiate the RECOVER-2 registrational trial in mid-2026, we remain focused on disciplined execution and bringing this promising therapy toward regulatory approval.” Business Highlights Clinical Development and Regulatory Published clinical vocal biomarker data from the RECOVER Phase 3 clinical trial highlighting the therapeutic potential of brilaroxazine for the treatment of schizophrenia in the peer-reviewed journal Biological Psychiatry, in an article entitled A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials.Announced a regulatory update following a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) regarding brilaroxazine. In written feedback, the FDA recommended a second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia to, ...