INmune Bio (NASDAQ: INMB) has 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).
According to INmune, it 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.
In a statement, Mark Lowdell, chief scientific officer of INmune, commented, “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. 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 has engaged U.S. regulatory advisors with rare disease expertise to prepare and submit a Type B meeting request to the FDA. Subject to feedback from that meeting, the Company plans to submit a Biologics License Application in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate.
