INmune Bio announced significant regulatory and commercial progress for its cell therapy, Ebstrocel™, for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). The company has submitted a pre-Marketing Authorisation Application (pre-MAA) to UK regulators and entered a strategic agreement with Uniphar to support international commercialization.
Key Details
- Regulatory Milestone: Submitted the final pre-Marketing Authorisation Application (pre-MAA) package to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ on October 20, 2026.
- Accelerated Timeline: The company now targets a full MAA submission in early February 2027, with potential UK approval in mid-2027. A U.S. Biologics License Application (BLA) is planned for Q2 2027.
- Commercial Agreement: Entered a Master Services Agreement with Uniphar to establish a framework for international access, distribution, and commercialization, initially focusing on named-patient access in select European and MENA markets.