INmune Bio files final UK pre-approval package for Ebstrocel
+1 new source since this summary was written
INmune Bio said it sent the UK MHRA its completed preliminary package for Ebstrocel, an investigational therapy for RDEB. It expects to lodge the complete UK marketing application in early February 2027, while the agency could respond within three to six months after submission. The company is preparing an FDA Type B meeting and targets a U.S. application in Q2 2027, with FDA review prioritized over an EMA filing.
Why it matters
The filing advances Ebstrocel toward formal UK review, but the therapy has not been approved. The next disclosed milestones are the MHRA response, the FDA meeting and a potential U.S. application, with timing dependent on regulatory review and feedback.
Key facts
- 1INmune Bio submitted its final pre-application package to the UK MHRA for Ebstrocel. investing.com
- 2The company intends to submit the complete UK application in early February 2027. investing.com
- 3INmune Bio expects an MHRA response within three to six months after submission. investing.com
- 4The company is seeking an FDA Type B meeting and targets a U.S. application for Q2 2027, conditional on feedback from that meeting. investing.com
Open questions
- UK approval timing remains dependent on application validation, agency review and any requests for additional information.
- Ebstrocel remains in clinical development and has not been approved by regulators.
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.