INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027
Key Highlights
- ➤Final pre-MAA package submitted to UK MHRA on October 20, 2026
- ➤Full UK MAA submission targeted for early February 2027
- ➤Potential UK approval moved forward approximately six weeks to mid-2027
- ➤U.S. BLA submission planned for Q2 2027
- ➤Ebstrocel™ targets recessive dystrophic epidermolysis bullosa
Expert Statements
Mark Lowdell, Chief Scientific Officer of INmune Bio
“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.”
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.”
David Moss, Chief Executive Officer of INmune Bio
“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.”
David Moss, Chief Executive Officer of INmune Bio
“With potential UK and U.S. approvals in 2027, we are approaching a pivotal year.”
David Moss, Chief Executive Officer of INmune Bio
“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.”
* Final pre-MAA package submitted to MHRA on October 20, 2026 * Full MAA submission targeted for early February 2027, under a revised strategy that could bring potential UK approval forward by approximately six weeks * U.S. BLA expected to be submitted in Q2, 2027 BOCA RATON, Fla., Oct. 21, 2026 (GLOBE NEWSWIRE) -- 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.
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