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 |
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
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital Southampton at the European Society for Medical Oncology (ESMO) Congress in Barcelona. The FOCUS trial was a pivotal Phase 3 study designed to evaluate the efficacy and safety of HEPZATO KIT™ in patients with unresectable hepatic metastases from mUM. The primary endpoint of the study was objective response ra
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 a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11, 2024 at 11:00 a.m. Eastern Time at the Lotte New York Palace Hotel in New York City. 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® Hepa
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, today announced the publication of a clinical study in the journal Therapeutic Advances in Medical Oncology. The publication, entitled "Melanoma-specific survival of patients with uveal melanoma and liver metastases diagnosed between 2005 and 2021", was based on an independent retrospective clinical study conducted by investigators from the University of Tübingen, Germany. The study demonstrates that first-line liver-directed therapies, including Delcath's CHEMOSAT® Hepatic Delivery System, significantly improve melanom
Delcath Systems, Inc. (NASDAQ:DCTH) (the "Company" or "Delcath"), an interventional oncology company specializing in the treatment of primary and metastatic liver cancers, today announced the publication of a retrospective study by independent investigators in the Annals of Surgical Oncology. The study, titled "Hepatic and Overall Progression-Free Survival After Percutaneous Hepatic Perfusion (PHP) as First-Line or Second-Line Therapy for Metastatic Uveal Melanoma," was conducted by researchers at Moffitt Cancer Center in Tampa, Florida. The 30-patient study reported that Delcath's HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) provided better disease control in the liver and improv
Delcath Systems, Inc. (NASDAQ:DCTH) ("Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of an independent study conducted by investigators at the University Hospital of Leipzig, Germany, in the European Society for Medical Oncology journal of Gastrointestinal Oncology. The study, titled "Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation," highlights the efficacy and safety of repeated chemosaturation treatments using Delcath's CHEMOSAT® Hepatic Delivery System. This press release features multimed
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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
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
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
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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Craig-Hallum analyst Chase Knickerbocker initiates coverage on Delcath Systems (NASDAQ:DCTH) with a Buy rating and announces Price Target of $18.
HC Wainwright & Co. analyst Swayampakula Ramakanth maintains Delcath Systems (NASDAQ:DCTH) with a Buy and raises the price target from $20 to $22.
Wall Street is experiencing a subdued trading session, with all major indices showing minimal movement around midday in New York. The latest producer inflation data provided mixed signals ahead of the highly anticipated consumer inflation report on Wednesday. Fed Chair Jerome Powell reiterated his outlook that U.S. monetary policy will maintain its current rate for a longer period than previously anticipated, dismissing fears of new rate hikes. President Joe Biden announced significant tariffs on Chinese imports, imposing 25% on steel and aluminum, 100% on electric vehicles made in China, 25% on EV batteries, and a 50% tariff on semiconductors from China. The U.S. dollar index (DXY)
Shares of Alibaba Group Holding Limited (NYSE:BABA) fell sharply during Tuesday's session following mixed first-quarter financial results. The e-commerce giant reported fiscal fourth-quarter 2023 revenue growth of 7% year-on-year to $30.73 billion, beating the analyst consensus estimate of $30.40 billion. Adjusted earnings per ADS of $1.40 missed the analyst consensus estimate of $1.41, according to data from Benzinga Pro. Alibaba Group shares tumbled 6.8% to $78.86 on Tuesday. Here are some other stocks moving in today’s mid-day session. Gainers Cheetah Net Supply Chain Service Inc. (NASDAQ:CTNT) shares jumped 352.4% to $5.34 as the company reported pricing of $8.19 million
Gainers Delcath Systems (NASDAQ:DCTH) stock rose 33.2% to $7.19 during Tuesday's regular session. The company's market cap stands at $199.8 million. As per the news, the Q1 earnings report came out today. Harrow (NASDAQ:HROW) stock rose 32.64% to $16.01. The company's market cap stands at $566.4 million. As per the press release, Q1 earnings came out yesterday. ProKidney (NASDAQ:PROK) shares moved upwards by 26.29% to $3.89. The company's market cap stands at $248.6 million. As per the news, the Q1 earnings report came out 2 days ago. Sunshine Biopharma (NASDAQ:SBFM) stock rose 25.14% to $1.09. The market value of their outstanding shares is at $1.0 million. Pacific Biosciences (NASDAQ:
U.S. stocks were higher, with the Dow Jones gaining around 20 points on Tuesday. Shares of Sony Group Corporation (NYSE:SONY) rose sharply during Tuesday's session after the company reported better-than-expected quarterly financial results. Sony Group reported fiscal fourth-quarter 2023 sales growth of 14% year-on-year to $23.49 billion (3.48 trillion Japanese yen), beating the analyst consensus estimate of $19.20 billion. EPS of $1.04 (153.60 yen) beat the analyst consensus estimate of 79 cents, according to data from Benzinga Pro. Sony Group shares gained 6.3% to $80.95 on Tuesday. Here are some other big stocks recording gains in today's session. AMC Entertainment Holdings
Stephens & Co. analyst Sudan Loganathan initiates coverage on Delcath Systems (NASDAQ:DCTH) with a Overweight rating and announces Price Target of $25.