INmune Bio Advances Ebstrocel™ Toward Potential UK Approval in Mid-2027
INmune Bio submitted its final pre-MAA package to the UK MHRA for Ebstrocel (CORDStrom), its cell therapy for recessive dystrophic epidermolysis bullosa, on October 20, 2026. Faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, replacing a sequential rolling submission, with potential UK approval in mid-2027 — about six weeks earlier than previously anticipated. In parallel, the company plans a Q2 2027 U.S. BLA submission, prioritizing FDA ahead of EMA and building on U.S.
Key figures
- Drug Name
- Ebstrocel (CORDStrom)
- Us bla target
- Q2 2027
- Mhra review window
- three to six months
- Maa submission target
- early February 2027
- Potential uk approval
- mid-2027
- Timeline acceleration
- approximately six weeks
- Pre maa submission date
- 2026-10-20
AI analysis
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