As of June 30, the company’s cash and cash equivalents totaled approximately $10.4M. “The successful completion of our global OLE 1-year trial marks a major milestone for the brilaroxazine program as we advance toward potential registration,” said Laxminarayan Bhat, founder, president, and CEO of Reviva. “This comprehensive dataset reinforces our prior positive clinical results and highlights the long-term safety, broad-spectrum sustained efficacy, and strong adherence profile of once daily brilaroxazine. We believe all key clinical data required for NDA are completed and we are preparing for an End-of-Phase 3 meeting with the FDA planned in the fourth quarter of the year to discuss our future NDA submission based on the current data package and excluding the planned Phase 3 RECOVER-2 trial. Pending favorable feedback from the FDA, we will target an NDA submission in the second quarter of 2026. Brilaroxazine continues to demonstrate a differentiated and durable clinical profile, positioning it as a potential new standard of care in schizophrenia and a meaningful driver of long-term value.”
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