{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-212940","form_type":"8-K","ticker":"DCTH","cik":"0000872912","company_name":"DELCATH SYSTEMS, INC.","filed_at":"2023-08-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:36.832037+00:00","generated_at":"2026-06-11T09:50:06.832420+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Delcath Systems receives FDA approval for HEPZATO KIT for metastatic uveal melanoma","bullets":["FDA approved HEPZATO KIT (melphalan/HDS) for unresectable hepatic-dominant metastatic uveal melanoma patients.","Phase 3 FOCUS study showed ORR 36.3%, median DoR 14 months, DCR 73.6%.","Approval triggers Tranche A warrants for up to $34.9M additional PIPE financing within 21 days.","Tranche B warrants for up to $24.9M exercisable upon $10M quarterly US revenue from HEPZATO.","Commercial product expected to be available in Q4 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-212940","json":"https://secwatch.observer/filing/0001193125-23-212940.json","markdown":"https://secwatch.observer/filing/0001193125-23-212940.md","text":"https://secwatch.observer/filing/0001193125-23-212940.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/872912/000119312523212940/0001193125-23-212940-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/872912/000119312523212940/d324309d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T09:50:06.832420+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"}