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 |
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)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
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
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
10-Q - DELCATH SYSTEMS, INC. (0000872912) (Filer)
8-K - DELCATH SYSTEMS, INC. (0000872912) (Filer)
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Fourth Quarter Revenue Approximately $15.1 Million and Full Year Total Revenue Approximately $37.2 Million 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 preliminary financial results for the fourth quarter and year-ended December 31, 2024. Preliminary Fourth Quarter and Full-Year 2024 Financial Results (unaudited) Total fourth quarter and full year revenue expected to be approximately $15.1 million and $37.2 million, respectively HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $13.7 million and $32.3 million,
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 an equity award, previously approved by the Company's Compensation Committee, as a material inducement to the employment of an individual whose employment commenced on November 4, 2024. The grant totaled the right to purchase 30,000 shares of the Company's common stock and is subject to the terms and conditions of the Company's 2023 Inducement Plan ("Plan"). The options were granted on December 31, 2024, the date the Compensation Committee approved the stock option included within th
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 the exercise of 1.7 million Series E and E1 warrants which resulted in $16.3 million of funding. Approximately 6.6% of the warrants exercised were subject to cashless exercise provisions. The warrants, issued in July and August 2019 as a component of a private placement, had an exercise price of $10.00 per share and expired on December 24, 2024. "With the exercise of these warrants, current cash on hand and cash expected from operations as a result of our revenue growth, we believe that we are in a str
Comprehensive Biotechnology sector market analysis and investment insights complement recently launched Disruptive Technology and Energy Transition franchises Clear Street, ("Clear Street", "the Company") a cloud-native financial technology firm on a mission to modernize the brokerage ecosystem, today announced the expansion of its recently launched equity research offering with the addition of Healthcare, initially focused on the biotechnology sector. The expanded research offering complements Clear Street's leading prime brokerage and clearing solutions for its rapidly growing client base of asset managers, institutions and professional traders across equities, fixed income, derivatives
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 colorectal cancer (mCRC). With the FDA's review complete, Delcath is now authorized to initiate patient enrollment. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and
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, today announced that management will be attending the following upcoming investor conferences: Stephens Biotechnology Virtual Fireside Chats Date: Wednesday, November 13, 2024 Fireside Chat Time: 9:30 am Eastern Time Location: Virtual 15th Annual Craig-Hallum Alpha Select Conference Date: Tuesday, November 19, 2024 1x1 Meetings Location: 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 prop
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
$10 Million Quarterly U.S. Revenue Triggers $25 Million Financing Tranche 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 preliminary revenue results for the third quarter of 2024, achieving $11.2 million, which included the recording of $10.0 million in U.S. revenue from the commercialization of HEPZATO KIT. The announcement of the recording of $10.0 million in U.S. quarterly revenue from the commercialization of HEPZATO KIT effectively triggers the exercise of Tranche B warrants issued in the previously announced March 29, 2023 Private Investment
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 three equity awards, previously approved by the Company's Compensation Committee, as a material inducement to the employment of three individuals whose employment commenced in August 2024. The grants totaled the right to purchase an aggregate of 46,000 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 August 30, 2024, the date the Compensation Committee approved the stock option
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
NEW YORK, March 19, 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 March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, March 26, 2024Time: 8:30 AM Eastern TimeParticipa
HEPZATO KIT is the only FDA approved liver-directed therapy to treat metastatic uveal melanoma Approval includes treatment naïve and previously treated patients and is not limited by HLA genotype Delcath to hold Business Update Call on August 15, 2023 at 8:00 a.m. Eastern Time NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic met
NEW YORK, Aug. 3, 2023 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that it plans to report the Company's 2Q23 earnings and issue its Form 10-Q the week of August 7, 2023. Subsequently, shortly after the FDA's decision on its HEPZATO™ KIT's new drug application ("NDA") resubmission, Delcath expects to hold a conference call to review the quarter and the details of the FDA action. Delcath currently expects the FDA to finish their review and take action on the application by the August 14, 2023 Prescription Drug User Fee Act ("PDUFA") date.
NEW YORK, May 12, 2023 /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 business highlights and certain preliminary financial results for the first quarter ended March 31, 2023. Recent Business Highlights During and since the first quarter, Delcath: Received an acknowledgement of Class 2 NDA resubmission from the U.S. Food and Drug Administration (FDA) for Hepzato Kit® (melphalan hydrochloride for Injection/Hepatic Delivery S
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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4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
4 - DELCATH SYSTEMS, INC. (0000872912) (Issuer)
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