Reviva Pharmaceuticals Holdings, Inc. reported financial results for the second quarter of 2025 and highlighted recent business achievements.
The company's focus on the brilaroxazine program for schizophrenia showed promising results in clinical trials, demonstrating efficacy and safety over a 1-year period.
Reviva disclosed plans for an NDA submission in the second quarter of 2026 and upcoming meetings with the FDA to discuss approval pathways.
Successful Clinical Trials
Completed successful Phase 2 and Phase 3 trials with positive clinical results and sustained efficacy over 1 year for brilaroxazine.
Financial Performance
Reported a net loss of $6.1 million for the second quarter of 2025, with cash and cash equivalents totaling $10.4 million as of June 30, 2025.
Future Milestones
Anticipates FDA meeting in Q4 2025, targeting NDA submission for brilaroxazine in Q2 2026, and plans for a Phase 3 trial for schizophrenia treatment.
- The successful completion of the Phase 2 and Phase 3 trials sets Reviva on a path towards potential registration and approval for brilaroxazine in treating schizophrenia.
- Positive clinical data and financial stability demonstrate Reviva's commitment to advancing therapeutic solutions for unmet medical needs in CNS disorders.
Reviva Pharmaceuticals Holdings has demonstrated significant progress with the brilaroxazine program, showcasing positive clinical outcomes and financial resilience. The company's strategic milestones align with its mission to address medical needs in CNS disorders, promising a potential new standard of care for schizophrenia.