INmune Bio Receives MHRA Alignment for CORDStrom™ UK MAA in RDEB
INmune Bio Inc. announced it received official meeting minutes from the UK Medicines & Healthcare products Regulatory Agency (MHRA) regarding its pre-Marketing Authorization Application (pre-MAA) for CORDStrom™ (Ebstrocel™) in Recessive Dystrophic Epidermolysis Bullosa (RDEB). The MHRA provided written alignment across all submitted questions, confirming agreement on CMC, non-clinical, and clinical evidence packages. This provides a clear regulatory path for the company's planned 2026 UK MAA submission, with EU and US submissions to follow.
Key Highlights
- INmune Bio received official MHRA pre-MAA meeting minutes for CORDStrom™ (Ebstrocel™) in RDEB.
- MHRA confirmed agreement across all questions covering CMC, non-clinical, and clinical evidence packages.
- MHRA recognized MissionEB Phase 2 data for clinically meaningful symptomatic benefits in RDEB.
- The data could support Ebstrocel™ as chronic or intermittent supportive therapy for RDEB.
- MHRA provided a clear regulatory path for INmune Bio's planned 2026 UK Marketing Authorization Application.
- Company will incorporate MHRA's endpoint recommendations into its confirmatory Phase 3 program.
- MHRA validated the proprietary pooled-donor approach and manufacturing transition plans.
- Regulators accepted the capital-efficient non-clinical safety package and suggested Bayesian analyses for rare diseases.
Price Impact
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