---
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"
generated_at: "2026-06-19T14:59:15.868051+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Delcath resubmits NDA to FDA for HEPZATO Kit in metastatic ocular melanoma

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-037853
- JSON: https://secwatch.observer/filing/0001193125-23-037853.json
- Plain text: https://secwatch.observer/filing/0001193125-23-037853.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.