INmune Bio Inc. (NASDAQ:INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The company has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review.
Following MHRA feedback on the final pre-MAA package, INmune Bio plans to finalize and submit a complete application in February 2027, replacing the sequential rolling submission previously planned to begin in late 2026. Based on progress in chemistry, manufacturing and controls (CMC) and discussions with regulatory advisors, the Company believes this approach could accelerate potential UK approval by approximately six weeks compared with the previously anticipated timeline.
The Company anticipates an MHRA response within three to six months after submission, subject to application validation, agency review and any requests for additional information. Submission of the complete package is intended to support assessment of the clinical, manufacturing and quality data together.
"This is a remarkable achievement by the whole CMC team and our external regulatory advisors allowing us to accelerate the potential approval for Ebstrocel for children with RDEB," said Mark Lowdell, Chief Scientific Officer of INmune Bio. "Our progress allows us to bring forward the anticipated timeline to commercial supply, subject to approval, for children and families waiting for treatment."
In parallel, INmune Bio U.S. Food and Drug Administration (FDA). Subject to feedback from that meeting, the Company plans to submit a Biologics License Application (BLA) in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate.
"Based on positive feedback from our regulatory consultants in the U.S, we are prioritizing our FDA application ahead of an EMA submission, building on Ebstrocel’s U.S. Orphan Drug and Rare Pediatric Disease designations," said David Moss, Chief Executive Officer of INmune Bio. "With potential UK and U.S. approvals in 2027, we are approaching a pivotal year. Approval in either or both markets would mark a major milestone for INmune Bio and bring Ebstrocel closer to patients and families living with RDEB."