Clinical EfficacyTreatment with brilaroxazine demonstrated broad-spectrum efficacy sustained over 1-year, including improvements in symptoms such as PANSS total score, positive and negative symptoms, and personal & social performance.
Financial StabilityReviva announced an equity financing of $9M in gross proceeds raised through the issuance of shares of common stock, with additional funds raised from warrant exercises, extending their financial runway.
Regulatory ProgressThe upcoming pre-NDA meeting with the FDA will clarify the regulatory path for brilaroxazine in schizophrenia and determine whether an additional P3 study will be required. A favorable outcome could position Reviva for an NDA submission based on positive P2, P3 (RECOVER-1), 1-year open label extension study, and pharmacology study data.