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

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

INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027

October 21, 2026 7:15 AM EDT

Final pre-MAA package submitted to MHRA on October 20, 2026Full MAA submission targeted for early February 2027, under a revised strategy that could bring potential UK approval forward by approximately six weeksU.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... More