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INmune Bio gets MHRA support for 2026 UK conditional approval of CORDStrom™ in rare skin disease RDEB

Market News
23 Jun 2026
GlobeNewsWire
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Bullish
pluang ai news

INmune Bio received written alignment from the UK MHRA on its 2026 plan to seek conditional marketing authorization for CORDStrom™ (Ebstrocel™) to treat Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder. MHRA agreed on the manufacturing, clinical, and non-clinical data requirements and recognized Phase 2 trial data showing meaningful symptom relief, especially for pain and itching, supporting its use as a chronic or intermittent therapy. The company is incorporating MHRA feedback into its Phase 3 trial design and aims to submit applications in the UK, EU, and US by late 2026 or early 2027. This regulatory milestone reduces risk and provides a clear path for potential approval of this novel cell therapy in an ultra-rare disease with limited treatment options.

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