INmune Bio submits EU regulatory filings for Ebstrocel in RDEB

Inmune Bio Inc., a late-stage biotechnology company focused on developing treatments for the innate immune system, has submitted EU regulatory filings for its investigational therapy Ebstrocel. The company aims to receive Orphan Drug Designation and pre-Marketing Authorization Application Scientific Advice from the European Medicines Agency for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

If granted, Ebstrocel could gain EU market exclusivity for up to 10 years, contingent on satisfying certain requirements. The submission aligns with INmune Bio's global registration strategy, which includes planned UK and U.S. filings. The therapy is part of INmune Bio's CORDStrom platform, which utilizes pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cells.

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