“With the comprehensive clinical and non-clinical data package in hand, we believe brilaroxazine is strongly positioned to meet New Drug Application filing requirements and advance toward potential registration for schizophrenia,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “The consistent body of evidence for brilaroxazine, from early clinical studies through long-term extension studies, continues to demonstrate broad-spectrum, durable efficacy, a favorable safety profile, and strong long-term adherence with once-daily dosing. We are preparing for a pre-NDA meeting with the Food and Drug Administration in the fourth quarter of the year and continue to target a potential NDA submission in the second quarter of 2026. We believe brilaroxazine’s differentiated clinical profile has the potential to redefine treatment expectations in schizophrenia and significantly improve patient outcomes worldwide.”
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