Ebstrocel UK Filing Accelerated to Feb 2027, Approval Targeted Mid-2027
INMB sits 50% above its 52-week low of $1.09 on light trading volume (0.2× avg).
Summary
INmune Bio submitted its final pre-MAA package to the UK MHRA for Ebstrocel in RDEB and is now planning a full MAA in early February 2027 instead of the rolling submission that was to start in late 2026. Management says faster CMC progress could pull potential UK approval to mid-2027, about six weeks earlier than previously guided. In parallel, the company has hired US regulatory advisors and will request a Type B FDA meeting, with a BLA targeted for Q2 2027 and prioritized ahead of an EMA filing. This follows the August disclosure that the pivotal CORDStrom trial was complete and a UK filing was planned for Q3-Q4 2026; the timeline has now shifted to a single complete application. The news is a modest de-risking of the regulatory path, but the company still carries a going concern warning and $18.4M in cash as of the Q2 10-Q, so financing remains the binding constraint before any 2027 approval.
At the time of this announcement, INMB was trading at $1.63 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $44.4M. The 52-week trading range was $1.09 to $2.60. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.