INmune Bio targets UK Ebstrocel approval in mid-2027
INMB•INmune Bio targets an early February 2027 UK approval application for Ebstrocel, with potential approval in mid-2027, and plans a US biologics license application in the second quarter of 2027, subject to FDA meeting feedback.
1. Regulatory timeline
INmune Bio targets an early February 2027 UK approval application for Ebstrocel, its investigational therapy for recessive dystrophic epidermolysis bullosa. The company says potential UK approval in mid-2027 could come approximately six weeks earlier under its revised submission strategy. A US biologics license application is planned for the second quarter of 2027, subject to FDA meeting feedback.
