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

INmune Bio establishes global commercialization framework for Ebstrocel™ through strategic agreement with Uniphar

INmune Bio Inc. (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has entered into a Master Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”) establishing a scalable framework to support international access, distribution and commercialization of Ebstrocel™, the Company’s allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB).

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

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

INmune Bio Establishes Global Commercialization Framework for Ebstrocel™ Through Strategic ...

Initial focus on named-patient access in selected European and MENA markets, providing a capital-efficient foundation for broader commercialization

INmune submits pre-MAA to MHRA for Ebstrocel in RDEB - BioTuesdays

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 […]

INmune Bio, Uniphar Deal Sets Global Route for Ebstrocel

Key Facts INmune Bio (NASDAQ: INMB) has signed a Master Services Agreement with Uniphar Durbin Ireland Limited covering international access, distribution and commercialisation of Ebstrocel™. Ebstrocel™ is an investigational allogeneic stromal cell therapy for recessive dystrophic epidermolysis bullosa (RDEB) and has not been approved by any regulator. The first use of the framework is named-patient access in selected European and MENA countr…

INmune Bio Establishes Global Commercialization Framework for Ebstrocel™ Through Strategic Agreement with Uniphar – Chicago Headlines

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