Approved liver-directed chemotherapy turns profitable; mCRC and mBC expansions determine whether uveal melanoma niche scales to durable franchise

Delcath Systems is a commercial-stage company with an approved drug that delivers chemotherapy directly to the liver to treat uveal melanoma that has spread to the liver, and it is now testing whether the same approach works for other cancers with liver involvement.

Delcath reached full-year profitability in 2025 on HEPZATO, an FDA-approved isolated hepatic perfusion system for uveal melanoma liver metastases, with revenue growing 129% to $85.2M. Whether the thesis scales turns on Phase 2 readouts in liver-dominant mCRC and mBC converting a narrow oncology niche into a broader liver-directed platform. The primary risk is that both expansions rely on single-arm or early-phase data in indications where systemic agents continue to evolve, creating approval-path and adoption uncertainty without randomized support.