Reviva Q1 2024 Earnings Report
Key Takeaways
Reviva Pharmaceuticals reported a net loss of $7.4 million, or $0.25 per share, for the first quarter ended March 31, 2024. The company's cash totaled $12.0 million as of March 31, 2024. They gained alignment with the FDA on brilaroxazine clinical trials for NDA submission in schizophrenia and expect to initiate the RECOVER-2 trial in Q2 2024.
Gained alignment with the U.S. Food and Drug Administration (FDA) on brilaroxazine clinical trials for New Drug Application (NDA) submission in schizophrenia.
The registrational RECOVER-2 trial is expected to initiate in Q2 2024, with topline data expected in Q3 2025.
Topline data from the 1-year open-label extension (OLE) trial is expected in Q4 2024.
Presented successful RECOVER-1 Phase 3 clinical trial data for brilaroxazine in schizophrenia at the 2024 Schizophrenia International Research Society (SIRS) Annual Meeting and the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2024 Annual Meeting.
Reviva
Reviva
Forward Guidance
Reviva anticipates several milestones and events, including the initiation of the registrational Phase 3 RECOVER-2 trial in Q2 2024 and topline data from the 1-year open-label extension (OLE) trial expected in Q4 2024. They also target a potential NDA submission for brilaroxazine in schizophrenia for Q4 2025.
Positive Outlook
- Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in Q2 2024
- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024
- Topline data from registrational Phase 3 RECOVER-2 trial expected Q3 2025
- Potential NDA submission for brilaroxazine in schizophrenia targeted for Q4 2025
- May initiate Phase 2a studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024