{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-078196","form_type":"8-K","ticker":"PHGE","cik":"0001739174","company_name":"BiomX Inc.","filed_at":"2025-08-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.847303+00:00","generated_at":"2026-05-17T11:30:51.655278+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA places clinical hold on BiomX's Phase 2b study of BX004 in CF due to nebulizer device","bullets":["FDA hold pauses U.S. enrollment and screening for BX004 Phase 2b trial; no concerns about BX004 itself.","Company submitted additional data to FDA; EU study continues as nebulizer is CE marked.","Clinical hold triggered by third-party nebulizer device, not drug candidate BX004.","BiomX noted risks in ability to resume U.S. enrollment and timing of hold resolution."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-078196","json":"https://secwatch.observer/filing/0001213900-25-078196.json","markdown":"https://secwatch.observer/filing/0001213900-25-078196.md","text":"https://secwatch.observer/filing/0001213900-25-078196.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1739174/000121390025078196/0001213900-25-078196-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1739174/000121390025078196/ea0253854-8k_biomx.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:30:51.655278+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"}