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INmune Bio Establishes Global Commercialization Framework for Ebstrocel with Uniphar

INmune Bio signed a Master Services Agreement with Uniphar to support named-patient access, distribution and commercialization of Ebstrocel in selected European and MENA markets. The scalable framework provides capital-efficient infrastructure that may expand to broader commercial distribution following regulatory approvals. This partnership advances Ebstrocel's international commercialization path ahead of planned MAA submission in early February 2027 and potential UK approval in mid-2027.

INmune Bio: MHRA approves PIP for Ebstrocel in RDEB

MHRA approved the Pediatric Investigation Plan for Ebstrocel, validating the clinical data package and clearing the first required step toward a UK Marketing Authorization Application. The approval, granted in under three months, aligns with the company's 2026 MAA filing timetable and provides written guidance on CMC, non-clinical and clinical strategy for the planned conditional marketing authorization.

INmune Bio receives MHRA alignment for 2026 UK MAA of Ebstrocel in RDEB

MHRA written minutes from the May 12 pre-MAA meeting confirm alignment on CMC, non-clinical and clinical packages, clearing the path for a 2026 UK Conditional Marketing Authorization Application. The agency recognized MissionEB Phase 2 data as showing clinically meaningful symptomatic benefit and endorsed positioning Ebstrocel as chronic or intermittent supportive therapy. INmune Bio will incorporate MHRA endpoint guidance into its confirmatory Phase 3 program and plans to use the feedback for future EMA and FDA filings.

INmune Bio: XPro1595 hits white-matter MRI endpoint in Ph2 MINDFuL Alzheimer’s trial

Phase 2 MINDFuL trial met its exploratory chi-separation MRI white-matter biomarker endpoint with statistically significant treatment effect in the full mITT population (p=0.0028, d=0.46, n=200) and a stronger effect in the inflammation-enriched subgroup (p=0.0098, d=0.59, n=100). The result validates target engagement on myelin and supports the precision-medicine strategy for the upcoming Phase 2b/3 registrational program.

INmune Bio: FDA Fast Track for XPro in early Alzheimer's

FDA granted Fast Track designation to XPro (pegipanermin) for early Alzheimer's disease. The designation provides expedited regulatory interactions and rolling review eligibility. No PDUFA date or other near-term catalyst is stated in the release.

INmune Bio plans CORDStrom BLA submission to FDA end-2026

The company states it will submit a BLA to the U.S. FDA for CORDStrom in RDEB toward the end of 2026, following an MAA filing to the UK MHRA planned for mid-summer 2026. The timelines are subject to regulatory feedback and manufacturing readiness. No filing has occurred yet; the letter only outlines the intended submission schedule.