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Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
Delcath Systems (Nasdaq:DCTH) announced two investigator-initiated trials-in-progress abstracts accepted for poster presentation at the ASCO 2026 Annual Meeting. Both studies evaluate the HEPZATO KIT percutaneous hepatic perfusion (PHP) system in metastatic melanoma with liver involvement, in combination or sequence with modern systemic therapies.
One Phase 2 trial in metastatic uveal melanoma pairs sequential HEPZATO PHP and tebentafusp, while a Phase 1b/2 trial studies HEPZATO with nivolumab/relatlimab in metastatic non-uveal melanoma. Enrollment began in November 2025 and January 2026, respectively.
Delcath Systems (Nasdaq:DCTH) granted equity awards as material inducements to four new employees who began in March or April 2026. The awards total 24,500 RSUs of common stock under the 2023 Inducement Plan and were granted on May 1, 2026.
One-third vests after one year, with the remaining two-thirds vesting in equal annual installments over two additional years, subject to continued employment. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4).
Delcath Systems (Nasdaq:DCTH), an interventional oncology company targeting primary and metastatic liver cancers, announced that its management will attend the H.C. Wainwright 4th Annual BioConnect Investor Conference on Tuesday, May 19, 2026 at Nasdaq in New York, NY.
Delcath Systems (Nasdaq: DCTH) reported Q1 2026 results and provided 2026 guidance. Total revenue was $25.0M (HEPZATO $23.3M; CHEMOSAT $1.7M). Gross margin was 85%. Net loss was $1.1M and adjusted EBITDA was $3.4M. Cash and investments totaled $89.3M as of March 31, 2026.
The company reaffirmed 2026 revenue guidance of at least $100M, projected gross margins of 84–87%, and positive adjusted EBITDA. Business highlights include ~36% HEPZATO volume growth YoY and 29 active centers.
Delcath Systems (Nasdaq: DCTH) announced presentation of new retrospective data on percutaneous hepatic perfusion with melphalan (M-PHP) for liver-dominant metastatic breast cancer at ESMO Breast Cancer Congress 2026 on May 7, 2026.
Presentation: e-poster at 13:15 local time, Abstract #574eP, presenter Cornelia Lieselotte Angelika Dewald, MD (Hannover Medical School). The analysis evaluates safety and feasibility of M-PHP using the CHEMOSAT Hepatic Delivery System.
Delcath Systems (Nasdaq: DCTH) will host a conference call on May 7, 2026 at 8:30 AM Eastern Time to discuss results for the first quarter ended March 31, 2026. Participants should dial in 5–10 minutes early or join the live webcast. A replay will be archived on the company website.
Dial-in numbers: Toll Free 1-800-717-1738; International 1-646-307-1865. Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1757946&tp_key=463dd4d428.
Delcath Systems (Nasdaq: DCTH) announced inclusion of its CHEMOSAT Hepatic Delivery System for Melphalan (M-PHP) as a recommended liver-directed regional therapy in the April 2026 ESMO–EURACAN clinical practice guideline for uveal melanoma. The guideline also cites two Phase 3 trials showing improved hepatic and overall progression-free survival and lists M-PHP first among regional options for multifocal liver-only metastases.
The guideline assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 for select patients and recognizes HEPZATO KIT as a Category 2A option for hepatic-dominant metastatic uveal melanoma.
Delcath Systems (NASDAQ:DCTH) will participate in the Society of Interventional Radiology 2026 Annual Scientific Meeting in Toronto, April 11–15, 2026.
The company’s Hepatic Delivery System for percutaneous hepatic perfusion (PHP) appears in three presentations on April 13 and April 15, 2026, featuring physicians from Massachusetts General Hospital, Thomas Jefferson University, and University of Wisconsin. Abstracts are available on the company website under Scientific Meetings.
Delcath Systems (Nasdaq: DCTH) announced publication of the CHOPIN randomized Phase 2 trial in The Lancet Oncology showing improved outcomes when combining percutaneous hepatic perfusion (PHP) with ipilimumab and nivolumab in metastatic uveal melanoma.
Key results: 1-year PFS 54.7% vs 15.8% (HR 0.34; p=0.0002), median PFS 12.8 vs 8.3 months, median OS 23.1 vs 19.6 months (HR 0.39; p=0.0065), ORR 76.3% vs 39.5%. Higher grade ≥3 toxicity in the combination arm (82% vs 41%) and one treatment-related death were reported.
Delcath (Nasdaq: DCTH) reported strong 2025 results with $85.2M revenue and $2.7M GAAP net income for the full year, plus $25.1M adjusted EBITDA. Fourth-quarter revenue was $20.7M and gross margins were 85%–86%. The company ended 2025 with $91.0M cash and no debt, repurchased 628,572 shares for $6.0M, and guided 2026 revenue to at least $100M with 84%–87% gross margins.
Clinical and commercial momentum included ~140% HEPZATO procedure-volume growth, 28 active centers, and published CHOPIN and FOCUS study results supporting adoption.