Reviva reports positive preliminary 1-year OLE data for brilaroxazine in schizophrenia

REVIVA PHARMACEUTICALS HOLDINGS, INC.

435 patients enrolled in OLE; 113 completed 52 weeks; pooled PANSS total decreased 18.6 points (p≤0.0001).
Dose-dependent efficacy: PANSS total decreases of -15.2, -18.6, -20.8 for 15, 30, 50 mg doses.
Safety: 15.2% TRAE, mostly mild; no drug-related SAEs; discontinuation rate 35%, primarily withdrawal of consent (22%).
Long-term safety data from 100+ patients meets FDA NDA submission requirement; full OLE data expected Q1 2025.
Brilaroxazine generally well-tolerated with no single side effect >5%; no clinically meaningful movement disorder changes.

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