secwatch.observer — SEC 8-K summary
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Issuer:     Inmune Bio, Inc. (INMB)
CIK:        0001711754
Form:       8-K
Filed at:   2026-02-13T23:59:59+00:00
Accession:  0001213900-26-016385
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

INmune Bio advances CORDStrom in UK, secures FDA alignment for XPro1595 Alzheimer's program
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- Submitted CORDStrom pre-submission package to UK MHRA for RDEB; targets full MAA filing mid-summer 2026.
- FDA aligns on integrated Phase 2b/3 design for XPro1595 in early Alzheimer's; CDR-SB sole primary endpoint.
- Phase 2b portion to enroll ~300 patients over 9 months; full program ~1,000 participants over 18 months.
- Biomarker-driven enrichment strategy (hsCRP, ESR, HbA1c, APOE4) accepted; exploratory non-enriched cohort included.
- CORDStrom also benefits from reauthorized Rare Pediatric Disease PRV program through 2029.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711754/000121390026016385/0001213900-26-016385-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711754/000121390026016385/ea0276865-8k_inmune.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-016385

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