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INmune Bio Advances Ebstrocel™ Toward European Marketing Authorization with EMA Regulatory Filings
Source: globenewswire.com
Healthcare & BiotechRegulation & LegislationCompany Fundamentals
The company submitted an Orphan Drug Designation application and a pre-MAA Scientific Advice package for Ebstrocel™ in RDEB, supporting a planned EU MAA in Q1 2027. If orphan designation is granted and maintained through approval, it may unlock regulatory incentives and 10 years of market exclusivity. This is a positive regulatory milestone, though it remains contingent on approval.
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