INmune Bio Inc. has submitted an Orphan Drug Designation application and a pre-Marketing Authorization Application Scientific Advice package to the European Medicines Agency for Ebstrocel, its investigational pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell therapy.
The filings target Recessive Dystrophic Epidermolysis Bullosa, a rare genetic disorder marked by severe skin fragility and chronic wounds. If granted, the orphan designation could provide up to 10 years of market exclusivity in the EU, subject to compliance with applicable requirements.
The company, based in Boca Raton, Florida, also plans to submit a Marketing Authorization Application in the EU during the first quarter of 2027. INmune Bio has already secured Orphan Drug Designation for Ebstrocel in the United States and intends to file for UK marketing authorization in the fourth quarter of 2026.
Ebstrocel is the first product from INmune Bio’s CORDStrom platform, which focuses on developing treatments targeting the innate immune system. Regulatory incentives such as protocol assistance and fee reductions may apply under the orphan designation process.
