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.
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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-26-016385), on February 13, 2026, and is solely responsible for the information contained therein.