{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-011517","form_type":"8-K","ticker":"INMB","cik":"0001711754","company_name":"Inmune Bio, Inc.","filed_at":"2025-02-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.543873+00:00","generated_at":"2026-05-27T00:13:25.016691+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"INmune Bio details CORDStrom regulatory path for RDEB; Phase 2 data shows itch reduction","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-011517","json":"https://secwatch.observer/filing/0001213900-25-011517.json","markdown":"https://secwatch.observer/filing/0001213900-25-011517.md","text":"https://secwatch.observer/filing/0001213900-25-011517.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1711754/000121390025011517/0001213900-25-011517-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1711754/000121390025011517/ea0230471-8k_inmune.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T00:13:25.016691+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}