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Delcath Systems Wins FDA Approval for Hepzato Kit


Delcath Systems experienced a significant surge in their stock value, with shares rising over 60% in premarket trading on Tuesday. The interventional oncology company received approval from the U.S. Food and Drug Administration (FDA) for their Hepzato Kit. This groundbreaking approval allows Delcath Systems to provide liver-directed treatment for specific patients with metastatic uveal melanoma.

The approved indication covers adults with unresectable hepatic metastases that affect less than 50% of the liver, without any extrahepatic disease. In cases where extrahepatic disease is present, it must be limited to the bone, lymph nodes, subcutaneous tissues, or lung and be amenable to resection or radiation.

This FDA approval also has a significant financial impact on Delcath Systems. It serves as a trigger for the second tranche of financing tied to their private investment in public equity (PIPE) earlier this year. Participants in the PIPE have 21 days to exercise their Tranche A warrants, which could result in additional funding of approximately $34.9 million.

Delcath Systems plans to make their commercial product available in the fourth quarter. This milestone achievement has already had a positive effect on their stock value. With shares closing at $3.12 on Monday, they have since experienced a remarkable increase of 63%, reaching $5.09 in premarket trading.

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