regulatory
confidence high
sentiment positive
materiality 0.70
INmune Bio details CORDStrom regulatory path for RDEB; Phase 2 data shows itch reduction
Inmune Bio, Inc.
- CORDStrom Phase 2 in 30 RDEB patients met endpoints on itch and skin scores; well tolerated with no related AEs.
- FDA granted Rare Pediatric Disease and Orphan Drug Designations; Type C meeting completed; pre-BLA meeting planned.
- Open-label trial starts mid-2025 in UK; INmune to file IND for US inclusion; BLA submission targeted by YE 2025.
- Potential US approval/launch in 2026; also seeking MAAs in UK and EU; >$1B peak sales opportunity for ~4,500 patients.