INmune Bio Receives MHRA Written Alignment Supporting Planned 2026 UK Conditional Marketing Authorization Application for CORDStrom™ in RDEB
INmune Bio received written alignment from the UK MHRA confirming agreement on CMC, non-clinical, and clinical strategies, paving the way for a planned 2026 Conditional Marketing Authorization Application for CORDStrom™ in RDEB. The agency validated the company's capital-efficient non-clinical safety package and recognized MissionEB Phase 2 data as showing clinically meaningful symptomatic benefits, specifically in pain and pruritus.
Key figures
- Drug Name
- CORDStrom™ (Ebstrocel™)
- Target year uk maa
- 2026
- Pediatric age range
- 0 to 18 years
- Target year eu us filing
- late 2026 or early 2027
AI analysis
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