Delcath Systems, Inc., an interventional oncology company, focuses on the treatment of primary and metastatic liver cancers in the United States and Europe. The company's lead product candidate is HEPZATO KIT, a melphalan hydrochloride for injection/hepatic delivery system to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. Its clinical development program for HEPZATO includes the FOCUS clinical trial for patients with hepatic dominant ocular melanoma to investigate objective response rate in metastatic ocular melanoma; and the ALIGN trial, a Phase 3 clinical trial for intrahepatic cholangiocarcinoma. The company also provides HEPZATO as a stand-alone medical device for sale under the CHEMOSAT Hepatic Delivery System for Melphalan trade name for medical centers to treat a range of liver cancers in Europe. Delcath Systems, Inc. was incorporated in 1988 and is headquartered in New York, New York.
IPO Year:
Exchange: NASDAQ
Website: delcath.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 6/28/2024 | $18.00 | Buy | Craig Hallum |
| 5/14/2024 | $25.00 | Overweight | Stephens |
| 7/26/2022 | $17.00 | Buy | Canaccord Genuity |
| 12/10/2021 | $25.00 | Buy | H.C. Wainwright |
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-16) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 05/29/2026. Application Category: NDA, Application Number: 201848, Application Classification: REMS
Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-7) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 10/01/2024. Application Category: NDA, Application Number: 201848, Application Classification: REMS
Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-3) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 05/22/2024. Application Category: NDA, Application Number: 201848, Application Classification: Labeling
Submission status for DELCATH SYSTEMS INC's drug HEPZATO (SUPPL-4) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 01/22/2024. Application Category: NDA, Application Number: 201848, Application Classification: REMS
Submission status for DELCATH SYSTEMS INC's drug HEPZATO (ORIG-1) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 08/14/2023. Application Category: NDA, Application Number: 201848, Application Classification: Type 4 - New Combination
For Immediate Release: August 15, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for information on a citizen petition asking the FDA to amend the standard of identity for pasteurized orange juice by lowering the minimum soluble solids content, known as the Brix level. Comments are due by October 16, 2023
Submission status for DELCATH SYSTEMS INC's drug HEPZATO KIT (ORIG-1) with active ingredient MELPHALAN HYDROCHLORIDE has changed to 'Approval' on 08/14/2023. Application Category: NDA, Application Number: 201848, Application Classification: Type 4 - New Combination
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4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
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Craig Hallum initiated coverage of Delcath with a rating of Buy and set a new price target of $18.00
Stephens initiated coverage of Delcath with a rating of Overweight and set a new price target of $25.00
Canaccord Genuity resumed coverage of Delcath with a rating of Buy and set a new price target of $17.00
H.C. Wainwright initiated coverage of Delcath with a rating of Buy and set a new price target of $25.00
Roth Capital reiterated coverage of Delcath Systems with a rating of Buy and set a new price target of $25.00 from $20.00 previously
Canaccord Genuity initiated coverage of Delcath Systems with a rating of Buy and set a new price target of $24.00
Canaccord Genuity initiated coverage of Delcath with a rating of Buy and set a new price target of $24.00
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4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
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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
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 th
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that management will be attending the H.C. Wainwright 4th Annual BioConnect Investor Conference on Tuesday, May 19, 2026 at Nasdaq in New York, NY. 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 desig
2026 Revenue Guidance of at least $100M Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the first quarter ended March 31, 2026. First Quarter 2026 Financial Results Total revenue of $25.0 million, compared with $19.8 million in the first quarter of 2025 HEPZATO KIT™ revenue of $23.3 million, compared to $18.0 million in the first quarter of 2025 CHEMOSAT® revenue of $1.7 million, compared to $1.8 million in the first quarter of 2025 Gross margins of 85%, compared to 86% in t
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT® Hepatic Delivery System was presented today at the ESMO Breast Cancer Congress 2026. Presentation details Congress: ESMO Breast Cancer Congress 2026 Date: May 7, 2026 Session: 13:15 (local congress time) Format: E-poster Title: Safety and Feasibility of Percutaneous Hepatic Perfusion with Melphalan in Patients with Liver-Dominant Metastatic Breast Cancer Presenter:
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on May 7, 2026, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 2026. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, May 7, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-800-717-1738 International: 1-646-307-1865 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1757946&tp_key=463dd4d428 A replay of the webinar will be available short
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
Publication Highlights Promise of Combined Percutaneous Hepatic Perfusion and Immunotherapy in Metastatic Uveal Melanoma Delcath Systems, Inc. (NASDAQ:DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center's Department of Medical Oncology. The publication, titled "Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre
Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025. Fourth Quarter and Full Year 2025 Financial Results Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively HEPZATO KIT™ fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively CHEMOSAT® fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively Gro
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on February 26, 2026, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2025. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, February 26, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1747469&tp_key=15ec7bd15c A replay of the w
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IRVINE, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (NASDAQ:BBNX), a pioneering leader in the development of advanced diabetes management solutions, today announced the appointment of Gerard Michel as an independent member of its board of directors, effective March 26, 2025. Mr. Michel is Chief Executive Officer of Delcath Systems (NASDAQ:DCTH), a commercial-stage interventional oncology company. "We are excited to welcome Gerard to the Beta Bionics Board," said Sean Saint, President and Chief Executive Officer of Beta Bionics. "Gerard is a highly regarded leader in the pharmaceutical and medical technology industries, and brings deep experience in driving innovation a
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, is pleased to announce the appointment of Dr. Bridget Martell to the Company's Board of Directors effective May 23, 2024. "We are pleased to welcome Dr. Martell to the Delcath Board," said John Sylvester, Chairman of the Delcath Board of Directors. "Dr. Martell's extensive experience serving both in senior management roles and as a director at multiple biotechnology companies, as well as her expertise in oncology clinical development, will be a great asset to Delcath as we strive to achieve our mission of improving pa
NEW YORK, March 18, 2024 /PRNewswire/ -- 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, is pleased to announce the appointment of Martha S. Rook as its new Chief Operating Officer (COO). Martha S. Rook, Ph.D., is an experienced industry leader who brings more than 25 years of academic and industry experience in molecular biology, diagnostics development, biologics process development and biologics manufacturing. She joins Delcath from insitro where she
NEW YORK, June 20, 2023 /PRNewswire/ -- 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, is pleased to announce the appointment of Dr. Vojislav "Vojo" Vukovic as its new Chief Medical Officer (CMO). Dr. Vukovic is an experienced drug development executive with a distinguished career in cancer research and global clinical development. His experience spans early to late-stage oncology clinical projects and global medical affairs programs across multiple a
WARREN, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced the appointment of Julie Krop, M.D., Chief Medical Officer of Freeline Therapeutics (NASDAQ: FRLN), and Marco Taglietti, M.D., Director, President and Chief Executive Officer of SCYNEXIS (NASDAQ: SCYX), to the Board of Directors of the Company effective February 10, 2021. Aquestive also announced the resignation of Douglas K. Bratton from the Board of Directors after more than 17 years of service. Aquestive’s Board of Directors
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2026 Revenue Guidance of at least $100M Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the first quarter ended March 31, 2026. First Quarter 2026 Financial Results Total revenue of $25.0 million, compared with $19.8 million in the first quarter of 2025 HEPZATO KIT™ revenue of $23.3 million, compared to $18.0 million in the first quarter of 2025 CHEMOSAT® revenue of $1.7 million, compared to $1.8 million in the first quarter of 2025 Gross margins of 85%, compared to 86% in t
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on May 7, 2026, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 2026. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, May 7, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-800-717-1738 International: 1-646-307-1865 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1757946&tp_key=463dd4d428 A replay of the webinar will be available short
Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025. Fourth Quarter and Full Year 2025 Financial Results Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively HEPZATO KIT™ fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively CHEMOSAT® fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively Gro
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on February 26, 2026, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2025. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, February 26, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1747469&tp_key=15ec7bd15c A replay of the w
Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the third quarter ended September 30, 2025. Third Quarter 2025 Financial Results Total revenue of $20.6 million, compared with $11.2 million in the third quarter of 2024 HEPZATO KIT™ revenue of $19.3 million, compared to $10.0 million in the third quarter of 2024 CHEMOSAT® revenue of $1.3 million, compared to $1.2 million in the third quarter of 2024 Gross margins of 87%, compared to 85% in the third quarte
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on November 4, 2025, at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2025. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, November 4, 2025 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1735083&tp_key=a3bb91787b A replay of the webinar will be a
Conference Call October 20, 8:45am EST Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today provided preliminary revenue and financial results for the quarter ended September 30, 2025, and updated 2025 full-year revenue guidance. Preliminary Third Quarter Financial Results (unaudited) Total CHEMOSAT and HEPZATO KIT revenue of approximately $20.5 million HEPZATO KIT revenue of $19.2 million CHEMOSAT revenue of $1.3 million Gross margins expected to be 87% Net income of $0.8 million Positive adjusted EBITDA of $5.3 million Positive operating cashflow of approximately $4.8 mill
Conference Call October 20, 8:45am EST Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the results of the CHOPIN randomized Phase 2 clinical trial (CHOPIN Trial) presented by Principal Investigator and Lead Author Professor Ellen Kapiteijn, MD, from Leiden University Medical Center's Department of Medical Oncology at the 2025 European Society of Medical Oncology (ESMO) Annual Congress. CHOPIN Trial Design The investigator-initiated, prospective, randomized Phase 2 CHOPIN Trial was designed to compare the safety, tolerability, and efficacy of Delcath's CHEMOSAT® Hepatic Delivery Sy
Conference Call Today at 8:30 a.m. Eastern Time Delcath Systems, Inc. (NASDAQ:DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the second quarter ended June 30, 2025. Second Quarter 2025 Financial Results Total revenue of $24.2 million, compared with $7.8 million in the second quarter of 2024 HEPZATO KIT™ revenue of $22.5 million, compared to $6.6 million in the second quarter of 2024 CHEMOSAT® revenue of $1.7 million, compared to $1.2 million in the second quarter of 2024 Gross margins of 86%, compared to 80% in the second q
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on August 6, 2025, at 8:30 AM Eastern Time to discuss results for its second quarter ended June 30, 2025. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Wednesday, August 6, 2025 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1723203&tp_key=fbe0333159 A replay of the webinar will be availab
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