secwatch.observer — SEC 8-K summary
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Issuer:     Inmune Bio, Inc. (INMB)
CIK:        0001711754
Form:       8-K
Filed at:   2026-10-21T13:00:34+00:00
Accession:  0001213900-26-111207
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

INmune Bio submits Ebstrocel pre-MAA to UK MHRA, targets approval in mid-2027
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711754/000121390026111207/0001213900-26-111207-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711754/000121390026111207/ea0309223-8k_inmune.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-111207

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer