regulatory
confidence high
sentiment positive
materiality 0.75
INmune Bio advances CORDStrom in UK, secures FDA alignment for XPro1595 Alzheimer's program
Inmune Bio, Inc.
- Submitted CORDStrom pre-submission package to UK MHRA for RDEB; targets full MAA filing mid-summer 2026.
- FDA aligns on integrated Phase 2b/3 design for XPro1595 in early Alzheimer's; CDR-SB sole primary endpoint.
- Phase 2b portion to enroll ~300 patients over 9 months; full program ~1,000 participants over 18 months.
- Biomarker-driven enrichment strategy (hsCRP, ESR, HbA1c, APOE4) accepted; exploratory non-enriched cohort included.
- CORDStrom also benefits from reauthorized Rare Pediatric Disease PRV program through 2029.