{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-204024","form_type":"8-K","ticker":"DCTH","cik":"0000872912","company_name":"DELCATH SYSTEMS, INC.","filed_at":"2023-08-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:36.831588+00:00","generated_at":"2026-06-12T06:46:25.266267+00:00","sec_items":["7.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.35,"calibrated_materiality_score":0.35,"confidence":"high","headline":"Delcath clarifies premature Hepzato staging site; no FDA decision; PDUFA Aug 14","bullets":["A vendor inadvertently published a staging site on Aug 4 suggesting possible Hepzato approval.","Delcath confirms it has not received any FDA decision regarding Hepzato as of filing date.","The PDUFA target date for Hepzato remains August 14, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-204024","json":"https://secwatch.observer/filing/0001193125-23-204024.json","markdown":"https://secwatch.observer/filing/0001193125-23-204024.md","text":"https://secwatch.observer/filing/0001193125-23-204024.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/872912/000119312523204024/0001193125-23-204024-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/872912/000119312523204024/d515102d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-12T06:46:25.266267+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"}