Reviva reports positive full dataset from Phase 3 OLE study of brilaroxazine in schizophrenia

REVIVA PHARMACEUTICALS HOLDINGS, INC.

Brilaroxazine showed sustained efficacy across all symptom domains: PANSS total score improved -18.1 at 12 months (p≤0.001).
Safety profile well-tolerated: 8.5% TEAEs mostly mild, no drug-related SAEs; discontinuation rate 35%.
Mild weight gain (1.52 kg) and no clinically significant cardiac, liver, or metabolic side effects.
Long-term safety data from 100 patients completing 1 year meets NDA submission requirement for FDA.
Improved multiple neuroinflammatory biomarkers; virtual webcast held June 2, 2025 at 8:00 a.m. EDT.

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