
INmune Bio plans to file Marketing Authorization Applications for CORDStrom in the UK by July 2026 and the EU by September 2026, with a Biologics License Application for the U.S. FDA targeted for December 2026.
Bullish
INmune Bio's CORDStrom showed positive pivotal trial results and received FDA orphan designations. XPro demonstrated a promising signal in a patient subgroup, and INmune Bio holds a robust IP portfolio for its platforms.
Bearish
INmune Bio faces substantial doubt about its going concern ability due to accumulated deficits and insufficient cash. XPro's Phase 2 trial failed its primary endpoint, leading to a significant impairment charge.