other material
confidence high
sentiment positive
materiality 0.75
Delcath provides Q1 preliminary results; PDUFA date Aug 14, closes $25M financing
DELCATH SYSTEMS, INC.
- 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.