Core Insights - Reviva Pharmaceuticals is advancing its late-stage brilaroxazine program, demonstrating sustained long-term safety and robust efficacy in treating schizophrenia, with a registrational Phase 3 trial expected to begin in mid-2025 [1][2][4] Clinical Program Highlights - Brilaroxazine has shown broad-spectrum efficacy across major symptom domains of schizophrenia, with long-term data indicating sustained efficacy over one year [2][5] - The open-label extension (OLE) study reported a decrease in PANSS total scores by 18.6 points, with significant reductions in both positive and negative symptoms [5] - The treatment was generally well tolerated, with a discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up, and no serious adverse events reported [5] Financial Results - For the fiscal year ended December 31, 2024, the company reported a net loss of approximately 39.3 million in 2023 [7][16] - Cash and cash equivalents as of December 31, 2024, totaled approximately 23.4 million in 2023 [7][14] Anticipated Milestones - Full data from the RECOVER OLE study, including biomarker data, is expected in Q2 2025 [2][11] - The initiation of the registrational Phase 3 RECOVER-2 trial is anticipated in mid-2025, with a potential New Drug Application (NDA) submission targeted for Q4 2026 [2][11]
Reviva Reports Full Year 2024 Financial Results and Recent Business Highlights