Financial PositionReviva 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 PathwayThe 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.
Safety ProfileNo clinically meaningful changes in movement disorder scales were observed, and benign weight gain was noted, indicating a favorable safety profile for brilaroxazine over a 1-year period.