BOCA RATON, Fla., Aug. 26, 2026

INmune Bio Inc. has advanced Ebstrocel™ toward potential European commercialization after submitting two regulatory packages to the European Medicines Agency (EMA) for the investigational therapy being developed for recessive dystrophic epidermolysis bullosa (RDEB). The company submitted an Orphan Drug Designation application and a pre-Marketing Authorization Application (MAA) Scientific Advice package, marking a significant regulatory step for Ebstrocel as INmune Bio prepares for a planned EU MAA in Q1 2027. The submissions are part of a broader registration strategy spanning the United Kingdom, European Union and United States, with the company targeting a UK MAA in Q4 2026 and a U.S. Biologics License Application in Q1 2027. Ebstrocel is the first product emerging from INmune Bio’s CORDStrom™ platform to advance toward potential marketing authorization.

EMA Filings Establish Next Regulatory Milestones

The EMA submissions are intended to support regulatory planning ahead of the proposed EU marketing application and provide the company with an opportunity to engage regulators before the formal MAA. The Orphan Drug Designation application seeks recognition for Ebstrocel in RDEB, complementing an orphan designation previously granted in the United States. If European orphan status is granted and subsequently maintained through marketing authorization, the approved orphan indication may qualify for 10 years of EU market exclusivity, subject to applicable regulatory requirements. The pre-MAA Scientific Advice package is designed to obtain EMA feedback on key scientific, regulatory and procedural considerations before the formal application, potentially helping INmune Bio identify important issues earlier in the registration process. Together, the filings create a defined regulatory pathway for Ebstrocel as the company moves from late-stage development toward potential commercialization.

Ebstrocel Targets Rare RDEB Disease

Ebstrocel™ is an investigational pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell therapy being developed as a systemic treatment for RDEB. The rare genetic disorder is associated with extreme skin fragility, chronic wounds, scarring and systemic complications, creating substantial unmet medical need. INmune Bio is developing Ebstrocel as a systemic therapeutic approach intended to address disease manifestations beyond localized wound management. The company says the therapy represents the first disease-specific product from its CORDStrom platform to reach the regulatory filing stage. The platform uses pooled allogeneic human umbilical cord-derived mesenchymal stromal cells and is designed to address challenges associated with donor variability and manufacturing consistency. INmune Bio’s manufacturing approach is intended to support scalable, reproducible and off-the-shelf cell therapy products, potentially allowing the platform to be applied across additional therapeutic programs.

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INmune Bio Builds Global Registration Strategy

The EMA filings represent another step in INmune Bio’s global regulatory strategy for Ebstrocel, with multiple potential registration milestones planned across major markets. The company expects its next major European milestone to be the planned EU MAA submission in Q1 2027, following the targeted UK filing in Q4 2026. A U.S. BLA submission is also planned for Q1 2027. Beyond Ebstrocel, progress with the CORDStrom platform is intended to provide a foundation for developing additional scalable cell therapies. INmune Bio is therefore using the Ebstrocel regulatory program not only to advance a potential treatment for RDEB but also to demonstrate the broader regulatory and manufacturing potential of its platform. The latest EMA filings move Ebstrocel closer to formal marketing applications and establish a clear sequence of regulatory activities as the company prepares for potential commercialization in multiple markets.

Source: INmune Bio press relese