INmune Bio Advances Ebstrocel™ Toward European Marketing Authorization with EMA Regulatory Filings

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).