INmune Bio Submits CORDStrom Pre-Submission Package to UK MHRA for RDEB Review

Reuters
Feb 14
INmune Bio Submits CORDStrom Pre-Submission Package to UK MHRA for RDEB Review

INmune Bio Inc. has submitted a pre-submission package for its CORDStrom™ therapy to the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), marking a significant step in the regulatory review process for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). This early engagement with the MHRA is intended to obtain targeted scientific, regulatory, and procedural feedback prior to filing a full Marketing Authorization Application $(MAA)$, which is currently planned for mid-summer 2026. Subsequent regulatory submissions in the European Union and the United States are expected to follow in the fourth quarter of 2026, pending regulatory alignment and manufacturing readiness.

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