secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2023-05-12T23:59:59+00:00
Accession:  0001193125-23-142792
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Delcath provides Q1 preliminary results; PDUFA date Aug 14, closes $25M financing
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- FDA set PDUFA goal date of August 14, 2023 for Hepzato Kit NDA resubmission.
- Closed initial $25M of up to $85M private placement led by Vivo Capital.
- Amended loan with Avenue Venture to defer $4.3M in principal payments through September 2023.
- Appointed John R. Sylvester as Chairman of the Board.
- CHOPIN trial: 7 uveal melanoma patients had median PFS of 29.1 months at 29.1-month follow-up.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000119312523142792/0001193125-23-142792-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000119312523142792/d495520d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-142792

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