MHRA aligns with INmune Bio on regulatory path for Ebstrocel in RDEB; UK MAA planned in 2026

Inmune Bio, Inc.

MHRA minutes from May 12 pre-MAA meeting confirm agreement across CMC, non-clinical, and clinical evidence packages.
Agency recognizes MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit in pain and pruritus.
MHRA provided endpoint recommendations for confirmatory Phase 3, moving away from wound closure as primary focus.
INmune Bio plans UK MAA submission in 2026; EU and US filings expected in late 2026 or early 2027.
Company states MHRA alignment de-risks regulatory path for CORDStrom platform and conditional authorization.

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