secwatch.observer — SEC 8-K summary
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Issuer:     Inmune Bio, Inc. (INMB)
CIK:        0001711754
Form:       8-K
Filed at:   2025-02-10T23:59:59+00:00
Accession:  0001213900-25-011517
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

INmune Bio details CORDStrom regulatory path for RDEB; Phase 2 data shows itch reduction
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- CORDStrom Phase 2 in 30 RDEB patients met endpoints on itch and skin scores; well tolerated with no related AEs.
- FDA granted Rare Pediatric Disease and Orphan Drug Designations; Type C meeting completed; pre-BLA meeting planned.
- Open-label trial starts mid-2025 in UK; INmune to file IND for US inclusion; BLA submission targeted by YE 2025.
- Potential US approval/launch in 2026; also seeking MAAs in UK and EU; >$1B peak sales opportunity for ~4,500 patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711754/000121390025011517/0001213900-25-011517-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711754/000121390025011517/ea0230471-8k_inmune.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-011517

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