regulatory
confidence high
sentiment positive
materiality 0.65
Reviva gains FDA alignment on Phase 3 RECOVER-2 study for brilaroxazine in schizophrenia
REVIVA PHARMACEUTICALS HOLDINGS, INC.
- FDA accepts 4-week RECOVER-2 study; two positive Phase 3 studies plus 12-month safety could support NDA.
- Topline data from 1-year OLE long-term safety trial expected Q4 2024; NDA submission targeted by Q3 2025.
- RECOVER-2 is a 450-patient global Phase 3 trial; primary endpoint is PANSS total score change at Day 28.
- Company plans to initiate first clinical site in Q2 2024.