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Market Impact: 0.18
INmune Submits EMA Regulatory Packages For Ebstrocel In Recessive Dystrophic Epidermolysis Bullosa
Source: Nasdaq
Healthcare & BiotechRegulation & Legislation
Inmune Bio submitted an EMA Scientific Advice package for Ebstrocel, including an Orphan Drug Designation request and a pre-Marketing Authorization Application (MAA) package. The filing is a constructive regulatory step toward potential EU review, but it does not by itself signal clinical efficacy or an approval timeline. Overall impact is likely limited in the near term.
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