INmune Bio Inc. announced two regulatory milestones: the submission of a pre-submission package to the UK MHRA for CORDStrom™ in RDEB and receipt of FDA meeting minutes confirming alignment on the Phase 2b/3 registration pathway for XPro1595 in early Alzheimer's Disease.
Key takeaways
On February 10, 2026, the Company submitted a pre-submission package for CORDStrom™ to the UK MHRA for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
The Company targets a full Marketing Authorization Application (MAA) filing with MHRA in mid-summer 2026, followed by EU and U.S. submissions in Q4 2026.
On February 12, 2026, the Company received FDA minutes confirming alignment on an integrated Phase 2b/3 design for XPro1595 in early Alzheimer's Disease.
The FDA raised no objection to using CDR-SB as the sole primary efficacy endpoint for the Phase 3 portion of the XPro1595 trial.
The FDA supported a biomarker-driven enrichment strategy for XPro1595 using biomarkers such as hsCRP, ESR, HbA1c, and APOE4.
CORDStrom™ has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation in the United States.