INmune Bio submits pre-MAA package for Ebstrocel, targets mid-2027 UK approval

INmune Bio Inc. (NASDAQ: INMB) announced it submitted its final pre-Marketing Authorisation Application package to the UK Medicines and Healthcare products Regulatory Agency on Oct. 20, 2026, for Ebstrocel (CORDStrom), an investigational cell therapy for recessive dystrophic epidermolysis bullosa.

The Boca Raton, Fla.-based company said it plans to submit a complete MAA in early February 2027, replacing a previously planned rolling submission that was set to begin in late 2026. The company said faster-than-expected manufacturing progress in chemistry, manufacturing and controls enabled the revised approach, which it estimates could bring potential UK approval approximately six weeks earlier than previously anticipated, targeting mid-2027, subject to MHRA review.

The company said it expects an MHRA response within three to six months after submission, subject to application validation and agency review.

In parallel, INmune Bio said it has engaged U.S. regulatory advisors with rare disease expertise and has prepared a Type B meeting request to the U.S. Food and Drug Administration. 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. The company cited Ebstrocel's U.S. Orphan Drug and Rare Pediatric Disease designations as factors in prioritizing the FDA submission ahead of a European Medicines Agency filing.

"Based on positive feedback from our regulatory consultants in the U.S., we are prioritizing our FDA application ahead of an EMA submission," said David Moss, chief executive officer of INmune Bio.

Recessive dystrophic epidermolysis bullosa is a rare genetic skin disorder. Ebstrocel has not been approved by the FDA, MHRA, or any regulatory body, and there is no assurance that approval will be granted.

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