INmune Bio announced that it has formally submitted a pre‑submission package to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its pooled mesenchymal stem cell product, CORDStrom, a potential first‑in‑class systemic therapy for recessive dystrophic epidermolysis bullosa (RDEB). The pre‑submission step is designed to secure early scientific, regulatory, and procedural feedback, thereby streamlining the subsequent full Marketing Authorization Application (MAA) and potentially shortening the time to market.
The company plans to file the full MAA in the UK in mid‑summer 2026, followed by EU and U.S. submissions in the fourth quarter of 2026. By engaging the MHRA early, INmune Bio aims to de‑risk the regulatory pathway and reduce the likelihood of costly delays that have historically plagued rare‑disease therapies.
CORDStrom’s development is underpinned by successful pilot‑scale manufacturing runs that met release criteria, demonstrating commercial‑grade production capability. Clinical data from the MissionEB trial showed meaningful improvements in itch, pain, skin integrity, and quality of life, with no treatment‑related serious adverse events, reinforcing the product’s safety and efficacy profile.
Financially, INmune Bio reported a net loss of $6.5 million for Q3 2025, an improvement from $12.1 million in Q3 2024, and held $27.7 million in cash and cash equivalents as of September 30 2025, providing a runway through the end of 2026. The company also highlighted its diversified pipeline, including XPro for Alzheimer’s disease and INKmune for cancer, underscoring a broader strategy beyond CORDStrom.
Professor Mark Lowdell, Co‑Founder and CSO, emphasized that the pre‑submission milestone marks a critical step toward bringing a systemic therapy to patients with RDEB, citing the positive safety and efficacy signals from MissionEB and the readiness of the manufacturing facility in Stevenage, UK. He added that the company remains focused on advancing the regulatory process while maintaining momentum across its pipeline.
In the United States, CORDStrom has received Orphan Drug Designation and Rare Pediatric Disease designation, and the reauthorization of the FDA’s Rare Pediatric Disease Priority Review Voucher program through September 30 2029 adds further incentive for development. These designations position INmune Bio to potentially secure expedited review and a market advantage if the therapy gains approval.
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