Delcath Systems published subgroup analyses of its Phase 3 FOCUS study on December 31, 2025, in the Journal of Cancer Research and Clinical Oncology. The analyses, which include 91 patients, dissect the efficacy and safety of the company’s HEPZATO KIT across age, sex, geographic region, tumor burden, and extra‑hepatic disease status.
The data confirm that patients with lower tumor burden achieved a higher overall response rate and longer progression‑free survival, while the safety profile remained consistent across all subgroups. Chief Medical Officer Vojislav Vukovic noted that the findings underscore the importance of early intervention to maximize clinical benefit and validate the platform’s ability to deliver high‑dose melphalan directly to the liver.
The publication follows Delcath’s Q3 2025 financial results, in which revenue reached $20.6 million—an 84 % year‑over‑year increase—but fell short of the $23.83 million consensus estimate. Earnings per share beat expectations by $0.24, driven by strong gross margins of 87 % and disciplined cost management. Cash and investments totaled $88.9 million, the company remains debt‑free, and a $25 million share‑repurchase program has been authorized.
The new subgroup data reinforce HEPZATO KIT’s value proposition, support reimbursement negotiations, and provide a data foundation for the company’s planned expansion into liver‑dominant metastatic colorectal and breast cancers. The evidence base also strengthens the case for broader adoption by clinicians and payers, potentially accelerating market penetration.
In pre‑market trading, Delcath’s shares fell 8.6 % as investors reacted to the revenue miss, despite the earnings beat. Analyst consensus remains a “Strong Buy” with a price target range of $21–$24, reflecting confidence in the company’s high‑margin business model and strategic growth pipeline.
Overall, the subgroup analyses deepen the clinical evidence for HEPZATO KIT, solidify its position as the only FDA‑approved liver‑directed therapy for unresectable metastatic uveal melanoma, and lay the groundwork for future indications that could broaden the company’s addressable market.
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