secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2023-08-04T23:59:59+00:00
Accession:  0001193125-23-204024
Event type: other_material
Sentiment:  neutral
Materiality: 0.35
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000119312523204024/0001193125-23-204024-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000119312523204024/d515102d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-204024

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer