INmune Bio Inc. (NASDAQ: INMB) has submitted two regulatory packages to the European Medicines Agency for its investigational cell therapy Ebstrocel™, according to a company statement.

The filings include an application for Orphan Drug Designation and a pre-Marketing Authorization Application Scientific Advice package for Ebstrocel™ in recessive dystrophic epidermolysis bullosa, a rare genetic disease marked by severe skin fragility and chronic wounds.

If the orphan designation is granted and maintained through approval, the therapy could receive 10 years of EU market exclusivity, along with regulatory incentives such as protocol assistance and fee reductions during development. INmune Bio already holds Orphan Drug Designation for Ebstrocel™ in the United States.

The EMA submissions are part of a broader global registration plan. The company is targeting a UK Marketing Authorization Application in Q4 2026, followed by an EU MAA and a U.S. Biologics License Application in Q1 2027.

Ebstrocel™ is the first product from INmune Bio's CORDStrom™ platform, described as a pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell therapy intended as a systemic treatment for RDEB.

"These EMA submissions are another execution milestone as we move Ebstrocel from late-stage clinical development toward potential commercialization," said David Moss, co-founder and Chief Executive Officer of INmune Bio.

Mark Lowdell, Chief Scientific Officer of INmune Bio and inventor of the CORDStrom™ platform, said: "Advancing Ebstrocel through European regulatory pathways is important for patients and for CORDStrom."

The pre-MAA Scientific Advice process is designed to allow the company to engage with the EMA on scientific, regulatory, and procedural requirements before submitting a full marketing authorization package. None of INmune Bio's product candidates have received regulatory approval.