Reviva Pharmaceuticals announces regulatory update regarding brilaroxazine

Reviva Pharmaceuticals (RVPH) announced a regulatory update following a pre-New Drug Application meeting with the U.S. Food and Drug Administration, FDA, regarding brilaroxazine in late-stage development for the treatment of schizophrenia. In written feedback, the FDA recommended a second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia to, among other things, generate additional efficacy data and expand the safety dataset. Subject to sufficient financing, Reviva plans to initiate the RECOVER-2 Phase 3 trial in the first half of 2026. The RECOVER-2 trial will be similar in design to the completed RECOVER Phase 3 trial of brilaroxazine. The FDA also provided the Company with guidance for, among other topics, methods of data analysis, methods of data presentation, and data requirements for studies of animal pharmacokinetics, human abuse potential, and renal and hepatic impairment.