---
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"
generated_at: "2026-06-11T09:50:06.832420+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Delcath Systems receives FDA approval for HEPZATO KIT for metastatic uveal melanoma

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-212940
- JSON: https://secwatch.observer/filing/0001193125-23-212940.json
- Plain text: https://secwatch.observer/filing/0001193125-23-212940.txt

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