other material
confidence high
sentiment positive
materiality 0.75
INmune Bio licenses MissionEB data, plans BLA for CORDStrom in pediatric RDEB
Inmune Bio, Inc.
- Plans to submit BLA in 2025 for CORDStrom to treat pediatric RDEB, supported by positive Phase 2 MissionEB data in 30 patients.
- Licensed exclusive commercial rights to MissionEB data from Great Ormond Street Hospital for £250k upfront and up to £6M milestone on first marketing authorization.
- FDA granted Rare Pediatric Disease Designation (RPDD) Dec 2024 and Orphan Drug Designation (ODD) Jan 2025, preserving PRV eligibility.
- CORDStrom well tolerated; severe RDEB patients had >27% sustained itch reduction at 6 months; younger and intermediate patients showed skin and pain improvements.
- Terminated existing SVB loan agreement with zero balance and no penalty; no financial impact.