other material
confidence high
sentiment neutral
materiality 0.75
INmune Bio pipeline update: CORDStrom Phase 3 data and XPro1595 FDA alignment for Phase 2b/3 AD trial
Inmune Bio, Inc.
- CORDStrom Phase 3 shows improvements in itch, pain, and skin scores in RDEB; MAA submission expected Q3 2026 for UK.
- XPro1595 Phase 2 MINDFuL trial met FDA end-of-Phase 2 meeting; adaptive Phase 2b/3 design with CDR-SB primary accepted.
- CORDStrom potential TAM >$1.4B; annual COG $120-180K; anticipated reimbursement ~$700K per year.
- XPro1595 showed zero ARIA events in high-risk APOE4+ population; Phase 3 readiness targeted for 2027.
- CORDStrom regulatory milestones: RPDD and ODD approved, pre-MAA doc submitted, BLA/MAA submissions planned in 2026.