Jun. 23 at 1:10 PM
$INMB INmune Bio announces MHRA alignment in pre-MAA CORDStrom meeting
INmune Bio announced that it has received official, accepted meeting minutes from its recent face-to-face pre-Marketing Authorization Application, or pre-MAA, Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency, or MHRA, for CORDStrom in Recessive Dystrophic Epidermolysis Bullosa. The May 12, meeting resulted in written alignment across all questions submitted by the company and provides a regulatory path for INmune Bio's planned 2026 UK Marketing Authorization Application, or MAA, seeking Conditional Marketing Authorization for Ebstrocel in RDEB. Ebstrocel is the name of the RDEB-specific investigational formulation derived from INmune Bio's proprietary CORDStrom off-the-shelf, pooled, human umbilical cord-derived mesenchymal stromal cell platform.
