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INmune Bio submits UK pre-MAA for Ebstrocel and partners with Uniphar for international access
INMBInmune Bio, Inc.
INmune Bio submitted its final pre-Marketing Authorisation Application package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel, an investigational cell therapy for recessive dystrophic epidermolysis bullosa. The company updated its regulatory strategy to target a full Marketing Authorisation Application submission in early February 2027, potentially advancing approval by six weeks. Concurrently, INmune Bio entered into a Master Services Agreement with Uniphar Durbin Ireland Limited to establish a scalable framework for international access and distribution, initially focusing on named-patient supply in selected European and MENA markets. This late-stage biotechnology company develops treatments targeting the innate immune system.