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Sep 30, 2024
Reviva Q3 2024 Earnings Report
Reviva reported results for the third quarter of 2024, highlighting progress in brilaroxazine program and upcoming milestones.
Key Takeaways
Reviva Pharmaceuticals reported a net loss of $8.4 million for Q3 2024. The company is advancing its brilaroxazine program, with topline data from the OLE trial expected in December 2024 and a potential NDA submission targeted for Q2 2026.
108 patients have completed one year of treatment in the 1-year open-label extension (OLE) trial.
Vocal biomarker speech latency data from the RECOVER trial reinforce brilaroxazine’s improvement on negative symptoms and other key symptom domains of schizophrenia.
Topline data from the OLE trial is expected in December 2024.
A potential NDA submission for brilaroxazine in schizophrenia is targeted for Q2 2026.
Reviva
Reviva
Forward Guidance
Reviva anticipates topline data from the 1-year OLE trial in December 2024 and full data analysis in Q1 2025. They expect to initiate the registrational Phase 3 RECOVER-2 trial in Q1 2025, subject to financing, and target a potential NDA submission for brilaroxazine in schizophrenia in Q2 2026.
Positive Outlook
- Topline data from 1-year OLE trial expected in December 2024
- Full data analysis of the OLE trial expected in Q1 2025
- Initiation of registrational Phase 3 RECOVER-2 trial expected in Q1 2025, subject to financing
- Potential NDA submission for brilaroxazine in schizophrenia targeted for Q2 2026
- Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2025
Challenges Ahead
- RECOVER-2 trial is subject to receipt of additional financing
- Potential for delays in clinical and regulatory timelines
- Dependence on successful clinical trial outcomes
- Risks associated with raising sufficient funding
- Uncertainties related to market opportunity and competitive position