US Market News
1月前
Delcath Systems Announces Two ASCO 2026 Investigator Initiated Trials-in-Progress AbstractsMay 26, 2026 4:01 PM
Business Wire Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced the publication of two investigator-initiated trials-in-progress abstracts on May 21, 2026. These abstracts will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The abstracts highlight ongoing clinical investigations evaluating the use of Delcath’s percutaneous hepatic perfusion (PHP) with melphalan using the HEPZATO KIT™ Hepatic Delivery System (HDS) in metastatic melanoma involving the liver — a common and difficult-to-treat site of disease progression. One abstract, titled "Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma," describes an investigator-initiated Phase 2 trial evaluating sequential treatment with HEPZATO followed by tebentafusp in patients with metastatic uveal melanoma (mUM) who are HLA-A*02:01 positive and have isolated or liver-dominant metastases. The study is designed to assess progression-free survival and additional measures including safety, objective response, overall survival, and biomarker analyses. The study opened for enrollment in November 2025. A second abstract, titled "Phase 1b/2 trial of melphalan-percutaneous hepatic perfusion (PHP) therapy and nivolumab/relatlimab in patients with metastatic melanoma and liver metastasis," outlines a single-center Phase 1b/2 study evaluating HEPZATO in combination with nivolumab/relatlimab as a first-line treatment approach for patients with metastatic non-uveal melanoma involving the liver. The trial is intended to assess safety, tolerability, and preliminary efficacy, with secondary objectives including disease control rate, progression-free survival, overall survival, duration of response, and tumor reduction. The study opened for enrollment in January 2026. The abstract on sequential PHP followed by tebentafusp in mUM (Abstract TPS9605) and the abstract on PHP plus nivolumab/relatlimab in metastatic melanoma with liver metastasis (Abstract TPS9600) will be presented as posters at the 2026 ASCO Annual Meeting. Specific session details will be available on the ASCO website. “We believe the publication of these two ASCO abstracts underscores the growing clinical interest in HEPZATO’s potential across multiple metastatic melanoma settings with liver involvement,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “These investigator-initiated trials will provide important insights into combining or sequencing liver-directed therapy with modern systemic treatments in patients with challenging disease. We remain committed to supporting such research to advance therapeutic options for patients with liver cancers and metastases.” About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING, for HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. View source version on businesswire.com: https://www.businesswire.com/news/home/20260526453584/en/ Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com Original: Delcath Systems Announces Two ASCO 2026 Investigator Initiated Trials-in-Progress Abstracts
US Market News
1月前
Delcath Systems, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)May 15, 2026 4:01 PM
Business Wire Delcath Systems, Inc. (Nasdaq: DCTH) (the “Company” or “Delcath”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the Company granted equity awards, previously approved by the Company’s Compensation Committee, as material inducements to four individuals whose employment commenced in either March 2026 or April 2026. The grants, in the form of Restricted Stock Units (RSUs), totaled 24,500 shares of the Company’s common stock and are subject to the terms and conditions of the Company’s 2023 Inducement Plan (“Plan”). The RSUs were granted on May 1, 2026 and one-third of the RSUs will vest on the first anniversary of the grant date with the remaining two-thirds of the RSUs vesting in equal annual installments over the following two years. The RSUs are subject to the employee’s continued employment with Delcath on each vesting date. The above-described awards were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and granted pursuant to the terms of the Plan. About Delcath Systems, Inc. Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. View source version on businesswire.com: https://www.businesswire.com/news/home/20260515653921/en/ Investor Relations:
ICR Healthcare
investorrelations@delcath.com Original: Delcath Systems, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
3月前
Delcath Systems, Inc. Announces Inclusion of CHEMOSAT Hepatic Delivery System for Melphalan as a Recommended Liver-Directed Regional Therapy Option in the ESMO–EURACAN Clinical Practice Guidelines for Uveal MelanomaApril 6, 2026 8:30 AM
Business Wire
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced that its proprietary CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026).
M-PHP is also recognized in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT™ (also referred to as melphalan/HDS), is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma (mUM). M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT.
The ESMO-EURACAN guideline recognizes M-PHP under regional treatments for patients with liver-dominant mUM. Two Phase 3 trials of M-PHP (NCT02678572 and NCT00324727) are cited as key supporting data, demonstrating improved hepatic and overall progression-free survival, and overall response rates compared with best alternative care. The guideline also assigns an ESMO-Magnitude of Clinical Benefit Scale score of 3 to M-PHP in the supplementary materials, for patients with unresectable hepatic metastases affecting
US Market News
3月前
Delcath Systems to Participate at the Society of Interventional Radiology 2026 MeetingApril 1, 2026 8:30 AM
Business Wire
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, will attend the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting, taking place April 11–15, 2026, in Toronto, Canada.
At the event, Delcath’s Hepatic Delivery System for use in percutaneous hepatic perfusion will be featured in three presentations.
On April 13, 2026, at 2:40 PM ET, Dr. Eric Wehrenberg-Klee, an interventional radiologist at Massachusetts General Hospital and Assistant Professor of Radiology at Harvard Medical School, will discuss his HEPZATO user experience at the SIR Innovation Hub;
On April 15, 2026, at 12:18 PM ET, Dr. David Eschelman, Professor of Radiology at Thomas Jefferson University, will present his initial commercial experience with percutaneous hepatic perfusion (PHP) for the treatment of liver metastases from uveal melanoma at Booth 701B; and
On April 15, 2026, at 12:27 PM ET, Dr. Mustafa Ege Seker, Research Fellow in the Department of Radiology, Section of Interventional Radiology from the University of Wisconsin, will present his preliminary clinical experience with percutaneous hepatic perfusion (PHP) for the treatment of liver metastases from uveal melanoma at Booth 701B.
The related abstracts are available at https://delcath.com/our-therapy/clinical-and-scientific-publications/ under Scientific Meetings.
About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260401496752/en/
Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com
Original: Delcath Systems to Participate at the Society of Interventional Radiology 2026 Meeting
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