---
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"
generated_at: "2026-06-12T06:46:25.266267+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.35
calibrated_materiality_score: 0.35
confidence: "high"
source: SEC EDGAR
---

# Delcath clarifies premature Hepzato staging site; no FDA decision; PDUFA Aug 14

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.35
- calibrated_materiality_score: 0.35
- confidence: high
- sec_items: 7.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-204024
- JSON: https://secwatch.observer/filing/0001193125-23-204024.json
- Plain text: https://secwatch.observer/filing/0001193125-23-204024.txt

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