{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-037853","form_type":"8-K","ticker":"DCTH","cik":"0000872912","company_name":"DELCATH SYSTEMS, INC.","filed_at":"2023-02-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:48.330719+00:00","generated_at":"2026-06-19T14:59:15.868051+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Delcath resubmits NDA to FDA for HEPZATO Kit in metastatic ocular melanoma","bullets":["NDA resubmission for HEPZATO Kit (melphalan/HDS) to FDA for unresectable hepatic-dominant metastatic ocular melanoma.","FDA to determine if resubmission is complete response to Sept 2013 CRL within 30 days; if accepted, PDUFA date set.","FOCUS trial results: ORR 36.3%, CR 7.7%, median DOR 14 months, DCR 73.6%, updated median OS 20.53 months.","Safety: 41.1% treatment-related serious AEs; no treatment-related deaths."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-037853","json":"https://secwatch.observer/filing/0001193125-23-037853.json","markdown":"https://secwatch.observer/filing/0001193125-23-037853.md","text":"https://secwatch.observer/filing/0001193125-23-037853.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/872912/000119312523037853/0001193125-23-037853-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/872912/000119312523037853/d455550d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-19T14:59:15.868051+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"}