INmune Bio says UK MHRA alignment supports planned 2026 conditional filing for CORDStrom in RDEB

INmune Bio, Inc.

INmune Bio, Inc.

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  • INmune Bio received MHRA written alignment from a May 12 pre-MAA Scientific Advice meeting for CORDStrom-derived Ebstrocel in RDEB.
  • The minutes support a planned 2026 UK Conditional Marketing Authorization filing, de-risking the regulatory path across CMC, non-clinical, clinical packages.
  • MHRA feedback cited Phase 2 MissionEB symptomatic benefit in pain, pruritus; flagged limited durability on wound closure, shaping Phase 3 endpoint strategy.
  • The agency accepted a pooled-donor manufacturing approach with comparability controls, allowing real-time manufacturing and stability updates during MAA review.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. INmune Bio Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606230800PRIMZONEFULLFEED9750859) on June 23, 2026, and is solely responsible for the information contained therein.