Delcath raises 2026 revenue guidance to $115-117 million, advances DELUMA trial
The company dosed its first breast cancer trial patient in July and reported about 72% growth in HEPZATO treatment volume for the third quarter.
Delcath Systems reported third quarter 2026 results on November 9, 2026 and increased its 2026 revenue guidance to a range of $115 million to $117 million.1
On the pipeline side, Delcath said it advanced the global Phase 2 DELUMA trial (NCT06875128), evaluating HEPZATO in combination with standard-of-care therapy versus standard of care alone in liver-dominant HER2-negative metastatic breast cancer, with the first patient dosed July 9, 2026, at the European Institute of Oncology in Milan, Italy.1 The randomized trial is designed to enroll approximately 90 patients at more than 20 U.S. and European sites.1
CEO Gerard Michel said the company is expanding its pipeline, with a planned IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP product by mid-2027.1
The company said treatment volume for HEPZATO grew approximately 72% in the third quarter of 2026 compared with the third quarter of 2025, and the company currently operates 33 active treatment centers.1 On revenue, the company reported HEPZATO KIT revenue of $32.7 million, compared to $19.3 million in the third quarter of 2025.1
For 2026 guidance details, the company said its outlook calls for total HEPZATO KIT and CHEMOSAT revenue to range from $115 million to $117 million, reflecting an increase in HEPZATO KIT volume of at least 41% over 2025, with full year gross margins in the range of 87% to 89% and positive adjusted EBITDA.1
The company also said it had $104.3 million in cash and investments as of September 30, 2026, and no debt.1
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