secwatch.observer — SEC 8-K summary
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Issuer:     Inmune Bio, Inc. (INMB)
CIK:        0001711754
Form:       8-K
Filed at:   2026-06-23T20:05:25+00:00
Accession:  0001213900-26-071082
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

MHRA aligns with INmune Bio on regulatory path for Ebstrocel in RDEB; UK MAA planned in 2026
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- MHRA minutes from May 12 pre-MAA meeting confirm agreement across CMC, non-clinical, and clinical evidence packages.
- Agency recognizes MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit in pain and pruritus.
- MHRA provided endpoint recommendations for confirmatory Phase 3, moving away from wound closure as primary focus.
- INmune Bio plans UK MAA submission in 2026; EU and US filings expected in late 2026 or early 2027.
- Company states MHRA alignment de-risks regulatory path for CORDStrom platform and conditional authorization.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711754/000121390026071082/0001213900-26-071082-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711754/000121390026071082/ea0295635-8k_inmune.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-071082

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