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FDA Asks Reviva Pharmaceuticals To Conduct Additional Phase 3 Study For Its Schizophrenia Drug
Benzingaยท 2025-12-23 14:26
Reviva Pharmaceuticals Holdings Inc. (NASDAQ:RVPH) on Tuesday announced a regulatory update following a pre-New Drug Application (pre-NDA) meeting with the U.S. Food and Drug Administration (FDA).The update is regarding brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator, in late-stage development for schizophrenia.In written feedback, the FDA recommended a second Phase 3 clinical trial for brilaroxazine in patients with schizophrenia to, among other things, generate addition ...