Delcath Systems Publishes FOCUS Study Subgroup Analysis Results
Delcath Systems announced the publication of results from subgroup analyses of the phase 3 FOCUS study. The publication was published in the Journal of Cancer Research and Clinical Oncology. The analysis assessed efficacy and safety in subgroups of patients treated with Delcath's Hepzato Kit, a drug/device combination for liver-directed treatment of mUM patients. The Hepzato Kit is currently the only liver-directed treatment to be approved by the FDA for patients with unresectable mUM. The article provides clinically relevant subgroup analyses of key efficacy endpoints, including overall response rate, progression-free survival and overall survival, and safety categories. Prespecified subgroups included age, sex, geographic region, extent of tumor liver involvement, hepatic tumor burden, presence of extrahepatic lesions, baseline LDH and number of prior therapies. This prespecified analysis of clinically relevant subgroups included 91 patients treated in the FOCUS study. Key efficacy and safety findings include: consistent tumor response was observed regardless of age, sex, geographic region, presence/absence of extrahepatic lesions, and prior therapy. Significantly higher ORR for patients with tumor burden below the median. No significant differences for other subgroups. Significantly longer median PFS for patients with tumor burden below the median. No significant differences for other subgroups. Significantly longer median OS for patients with smaller extent of tumor liver involvement, tumor burden below the median and low/normal LDH. Of the 33 patients achieving an objective response, 57.6% responded within the first or second treatment cycle, while one-third of responses were observed in Cycles 4-6. The overall safety profile was similar across subgroups, with no evidence of cumulative toxicity with successive treatment cycles. The incidence of serious adverse events and Grade 3/4 adverse events was consistent with the overall study population, and no treatment-related deaths occurred.
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Delcath Systems Reports Preliminary 2025 Revenue of $85.2 Million
- Revenue Growth: Delcath anticipates fourth quarter and full-year 2025 revenues of approximately $20.7 million and $85.2 million, indicating sustained growth potential in the liver cancer treatment sector.
- HEPZATO KIT Performance: Expected revenues for HEPZATO KIT are around $19.0 million and $78.8 million, reflecting strong market demand for the product and further solidifying Delcath's position in liver cancer treatment.
- Share Buyback Program: As of December 31, 2025, the company repurchased 628,572 common shares for $6.0 million, demonstrating confidence in its own value and creating shareholder returns.
- Clinical Trial Progress: HEPZATO procedure volume grew approximately 140% in 2025, showcasing the company's success in promoting new treatment options, which is expected to drive future revenue growth.

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- OPXS Business Growth: Optex Systems Holdings is experiencing rising revenue and expanding margins through the design and manufacture of advanced optical sighting systems, indicating stable demand and financial health in the defense market.
- DCTH Business Transformation: Delcath Systems is commercializing its FDA-approved liver cancer treatment, with revenue gradually increasing, marking a successful transition from development to execution and addressing a serious medical need.
- MAMA Expansion Momentum: Mama's Creations is growing revenue at a healthy pace through fresh food sales in supermarkets and club stores nationwide, while maintaining operational leverage and balance sheet discipline, showcasing sustainable growth potential.
- Common Traits: All three companies are improving financial quality alongside revenue growth, indicating their long-term investment value in the microcap market, quietly strengthening while the market is distracted.






