Reviva Pharmaceuticals Holdings Inc. announced plans to initiate the RECOVER-2 Phase 3 registrational trial for brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator for the treatment of schizophrenia. The initiation of the trial is expected in the first half of 2026, pending sufficient financing. This decision follows written feedback from the U.S. Food and Drug Administration (FDA) after a pre-New Drug Application (pre-NDA) meeting, in which the FDA recommended a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission. The RECOVER-2 trial will be similar in design to the previously completed RECOVER Phase 3 trial. No new clinical results were presented at this time.

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