Delcath Systems, Inc. (NASDAQ: DCTH) has secured a key clinical endorsement when its CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M‑PHP) was incorporated as a recommended liver‑directed regional therapy in the newly published 2026 ESMO–EURACAN clinical practice guidelines for uveal melanoma.
The guideline, released on April 6 2026, lists CHEMOSAT as a preferred treatment for patients with metastatic uveal melanoma, underscoring the system’s ability to deliver high‑dose chemotherapy directly to the liver while limiting systemic exposure. The recommendation follows the company’s successful U.S. launch of its HEPZATO KIT and the positive data from the CHOPIN trial, which demonstrated superior progression‑free and overall survival when M‑PHP is combined with immunotherapy.
Delcath’s 2025 financial results provide context for the guideline endorsement. The company reported full‑year revenue of $85.2 million, up 93% from $37.2 million in 2024, and a net income of $2.7 million, a turnaround from a $26.4 million loss the previous year. Gross margins remained strong at 86%, and the company guided 2026 revenue to $100 million or more, driven by a projected 20% increase in HEPZATO kit volume. The guideline inclusion is expected to accelerate adoption, support reimbursement discussions, and reinforce the company’s competitive moat in interventional oncology.
The CHOPIN trial, published in The Lancet Oncology, showed that M‑PHP with melphalan improves progression‑free and overall survival when paired with immunotherapy. The trial’s results have been cited as a key catalyst for the guideline recommendation and are expected to further drive clinical uptake of CHEMOSAT and HEPZATO.
Management highlighted the significance of the endorsement. CEO Gerard Michel said, "This inclusion in the ESMO‑EURACAN guidelines represents an important validation of PHP with melphalan as a meaningful liver‑directed therapy for patients with mUM." CFO Sandra Pennell added, "The revenue guidance reflects the 340B pricing change. And based on our current and projected customer mix, we do expect the 340B pricing impact to result in an average selling price of around $175,000 per kit for HEPZATO, approximately a 10% discount of our published list price."
The guideline recommendation is expected to broaden clinical adoption of Delcath’s technology, potentially increasing kit sales and reinforcing the company’s position as a leader in liver‑directed oncology. The endorsement also positions Delcath to pursue future reimbursement discussions and expand its treatment center network, targeting 40 active centers by the end of 2026.
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