INmune Bio files for EMA orphan drug status for its RDEB cell therapy
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INmune Bio Advances Ebstrocel™ Toward European Marketing Authorization with EMA Regulatory Filings
August 26, 2026 7:00 AM EDTOrphan 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... More
