Orphan Drug Designation application and pre-MAA Scientific Advice package submitted for Ebstrocel™ in RDEB

Filings support a planned EU MAA in Q1 2027; orphan designation, if granted and maintained through approval, may provide regulatory incentives and 10 years of market exclusivity

BOCA RATON, Fla., Aug. 26, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB) ("INmune Bio" or the "Company"), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted two regulatory packages to the European Medicines Agency (EMA) for Ebstrocel™: an application for Orphan Drug Designation and a Scientific Advice package to streamline the upcoming Marketing Authorization Application (MAA) in Europe. Ebstrocel™, the first product from the Company’s CORDStrom™ platform, is an investigational pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell therapy being developed as a systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB).

The EMA filings are intended to support the Company’s planned EU MAA in Q1 2027 and form part of a coordinated global registration strategy that includes a planned UK MAA in Q4 2026 and a planned U.S. Biologics License Application (BLA) in Q1 2027.

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