INMB News & Events

INmune Bio announced that the UK Medicines & Healthcare products Regulatory Agency, or MHRA, has approved the pediatric investigation plan, or PIP, for Ebstrocel for the treatment of Recessive Dystrophic Epidermolysis Bullosa, or RDEB. The approval of the PIP is the first required stage toward a marketing authorization application, or MAA, submission in the United Kingdom. This regulatory milestone remains aligned with the company's established timetable for an MAA filing in 2026 and a US filing for Accelerated Approval in early 2027.

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.

INmune Bio announced positive results from exploratory MRI imaging analyses of its MINDFuL Phase 2 trial of XPro in patients with early Alzheimer's disease. "A statistically significant treatment effect on white matter across the full mITT population, strengthening further in inflammation-enriched patients, tells us that XPro is doing exactly what it is designed to do, with increased effect in patients we intend to treat in the registrational study," said David Moss, CEO of INmune Bio. INmune Bio plans to present the complete dataset at the Alzheimer's Association International Conference in July.