INmune Bio submits final Ebstrocel UK pre-MAA package and signs Uniphar agreement
INmune Bio said it submitted its final pre-Marketing Authorisation Application package for Ebstrocel to the UK MHRA on October 20, 2026, and revised its plan to a full application in February 2027, with potential UK approval in mid-2027, subject to MHRA review. It also signed a Master Services Agreement with Uniphar Durbin Ireland Limited to support international access and distribution, starting with named-patient access in selected European countries and the Middle East and North Africa. The filing does not disclose any financial terms of the Uniphar agreement or any revenue expectations.
Key points
- Final pre-MAA package submitted to the UK MHRA on October 20, 2026; full MAA submission targeted for early February 2027
- Company believes the revised approach could bring potential UK approval forward by approximately six weeks; MHRA response expected three to six months after submission
- U.S. Biologics License Application planned for the second quarter of 2027, subject to FDA feedback from a Type B meeting request
- Uniphar agreement initially targets named-patient access in selected European countries and MENA; no financial terms disclosed
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 21, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.