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 |
10-Q - DELCATH SYSTEMS, INC. (0000872912) (Filer)
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
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8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
10-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
10-Q - DELCATH SYSTEMS, INC. (0000872912) (Filer)
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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
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
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 first quarter ended March 31, 2025. First Quarter 2025 Financial Results Total revenue of $19.8 million, compared with $3.1 million in the first quarter of 2024 HEPZATO KIT™ revenue of $18.0 million, compared to $2.0 million in the first quarter of 2024 CHEMOSAT® revenue of $1.8 million, compared to $1.1 million in the first quarter of 2024 Gross margins of 86%, compared to 71% in the first quarter of 2
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 8, 2025, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 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, May 8, 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=1713022&tp_key=6de250d858 A replay of the webinar will be available shortly a
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, 2024. Fourth Quarter and Full Year 2024 Financial Results Total fourth quarter and full year revenue of $15.1 million and $37.2 million, respectively HEPZATO KIT™ fourth quarter and full year revenue of $13.7 million and $32.3 million, respectively CHEMOSAT® fourth quarter and full year revenue of $1.4 million and $4.9 million, respectively Gross mar
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 March 6, 2025, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2024. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, March 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=1706497&tp_key=9763647546 A replay of the webinar will
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 third quarter ended September 30, 2024. Third Quarter and Recent Business Highlights Total third quarter revenues of $11.2 million, up 44% from the prior quarter, including $10.0 million from HEPZATO KIT™ (melphalan/Hepatic Delivery System) and $1.2 million from CHEMOSAT®; Activated four HEPZATO treatment centers in the U.S. during the third quarter and one more in October, bringing the total to twelve
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 8, 2024, at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2024. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Friday, November 8, 2024 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=1691899&tp_key=9d94cb0736 A replay of the webinar will be availab
Company Reports $7.8 million in Quarterly Revenue Conference Call Today at 4:30pm 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 second quarter ended June 30, 2024. Recent Business Highlights Recognized second quarter 2024 revenues of $6.6 million from sales of HEPZATO KIT™ (melphalan/Hepatic Delivery System) and $1.2 million in CHEMOSAT sales; Activated three HEPZATO KIT treating centers in the US during the second quarter with an additional center in July for a total of eigh
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 5, 2024, at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2024. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Monday, August 5, 2024 Time: 4:30 PM Eastern Time Participant Numbers: Toll Free: 1-877-407-3982 International: 1-201-493-6780 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1679582&tp_key=87da4fb106 A replay of the webinar will be available
Conference Call Today at 8:30 am Eastern Time QUEENSBURY, N.Y., May 14, 2024 /PRNewswire/ -- 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 first quarter ended March 31, 2024. Recent Business HighlightsDuring and since the first quarter, Delcath: Recognized over $2.0 million of revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.1 million in CHEMOSAT sales through
QUEENSBURY, N.Y., May 7, 2024 /PRNewswire/ -- 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 14, 2024, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 2024. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, May 14, 2024Time: 8:30 AM Eastern Time Participant Numbers:Toll Free: 1-833-630-1960Inte
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 first quarter ended March 31, 2025. First Quarter 2025 Financial Results Total revenue of $19.8 million, compared with $3.1 million in the first quarter of 2024 HEPZATO KIT™ revenue of $18.0 million, compared to $2.0 million in the first quarter of 2024 CHEMOSAT® revenue of $1.8 million, compared to $1.1 million in the first quarter of 2024 Gross margins of 86%, compared to 71% in the first quarter of 2
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC). With the FDA's review complete, Delcath is now cleared to initiate patient enrollment in the U.S. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC foll
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 8, 2025, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 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, May 8, 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=1713022&tp_key=6de250d858 A replay of the webinar will be available shortly a
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of a comparative analysis from the randomized cohort of the Company's Phase 3 FOCUS study in Annals of Surgical Oncology. The study, titled "An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma," indicates that treatment with the Melphalan/Hepatic Delivery System (Melphalan/HDS) shows a trend toward favorable clinical outcomes compared to best alternative care (BAC), which included the physician's choice of dacarbazine, tran
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), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that management will participate in the CG Horizons in Oncology Virtual Conference on April 7, 2025 at 10:00 a.m. ET. Investors interested in participating should contact their Canaccord representative. 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 Me
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 six individuals whose employment commenced in January and February of 2025. The grants resulted in the right to purchase 264,000 shares of the Company's common stock and are subject to the terms and conditions of the Company's 2023 Inducement Plan ("Plan"). The options were granted on February 28, 2025, the date the Compensation Committee approved the stock option included within the
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, 2024. Fourth Quarter and Full Year 2024 Financial Results Total fourth quarter and full year revenue of $15.1 million and $37.2 million, respectively HEPZATO KIT™ fourth quarter and full year revenue of $13.7 million and $32.3 million, respectively CHEMOSAT® fourth quarter and full year revenue of $1.4 million and $4.9 million, respectively Gross mar
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 March 6, 2025, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2024. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, March 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=1706497&tp_key=9763647546 A replay of the webinar will
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 announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of metastatic uveal melanoma (mUM). Our 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. The updated NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment
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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