“Our late stage brilaroxazine program is advancing towards registration and we are excited for our important near-term catalysts ahead. Notably, the full dataset from our global OLE trial will include data from 446 participants of which 156 have completed at least one-year of treatment. We look forward to reporting clinical response, safety, adherence, and biomarker data in the second quarter of the year,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Brilaroxazine continues to demonstrate what we believe is a differentiated and promising therapeutic profile across our robust data package that is expected to include a successful placebo-controlled Phase 3 trial with a long-term open label extension for up to 1-year, a successful Phase 2 study, and a compelling drug-drug interaction study. We believe the findings from these studies reinforce the potential of once daily brilaroxazine to address major unmet needs for patients with schizophrenia, and we are targeting a potential New Drug Application submission for brilaroxazine in the fourth quarter of 2026.”
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