regulatory
confidence high
sentiment positive
materiality 0.75
INmune Bio submits Ebstrocel pre-MAA to UK MHRA, targets approval in mid-2027
Inmune Bio, Inc.
- Submitted final pre-MAA package for Ebstrocel (CORDStrom) to the UK MHRA on October 20, 2026; full MAA targeted for early February 2027.
- INmune Bio says the revised strategy could accelerate potential UK approval by about six weeks, with possible approval in mid-2027 subject to MHRA review.
- Signed a Master Services Agreement with Uniphar Durbin Ireland to support named-patient access in selected European and MENA markets.
- Plans a Type B meeting request with the FDA and a BLA submission in Q2 2027, seeking traditional or accelerated approval as appropriate.
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