Delcath Systems Stock Soars 90% In One Session - Here's Why

The FDA approved Delcath Systems Inc's DCTH HEPZATO KIT (melphalan/Hepatic Delivery System). 

The approval is as a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

The company plans to have commercial product available in the fourth quarter, and patients will continue to be enrolled and treated at Expanded Access Program (EAP) sites.

The approval of HEPZATO KIT was based primarily on the results of the FOCUS Phase 3 Study.

The approval triggers the second tranche of financing tied to the previously announced March 29, 2023 Private Investment in Public Equity (PIPE) financing. 

Participants in the PIPE have 21 days to exercise their Tranche A warrants, translating to approximately $34.9 million in additional funding to Delcath. 

In addition, upon the company's announcement of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO KIT, participants in the PIPE will have 21 days to exercise their Tranche B warrants, resulting in up to an additional $24.9 million in funding to Delcath.

Price Action: DCTH shares are up 90.70% at $5.95 on the last check Tuesday.