Biotech News

INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027

INmune Bio (INMB)INmune BioFDA / regulatory

INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The company has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review.

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INmune Bio

Innate-Immune Therapeutics INmune Bio develops therapies that modify innate immune responses. Its programs span cell therapy, neuroinflammation and cancer biology. CORDStrom CORDStrom is an allogeneic umbilical-cord-derived stromal-cell therapy being developed for recessive dystrophic epidermolysis bullosa, a severe inherited skin...

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Biopharma
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