Welcome to our dedicated page for Delcath Sys news (Ticker: DCTH), a resource for investors and traders seeking the latest updates and insights on Delcath Sys stock.
The Delcath Systems Inc (DCTH) news page on Stock Titan aggregates company announcements, clinical updates, and financial disclosures for this interventional oncology business focused on primary and metastatic liver cancers. Delcath’s communications frequently highlight developments related to its proprietary hepatic delivery technologies, HEPZATO KIT and the CHEMOSAT Hepatic Delivery System for Melphalan, which are used in percutaneous hepatic perfusion (PHP) procedures.
Investors and observers can use this news feed to follow earnings reports and financial updates, including quarterly and preliminary revenue results, product revenue from HEPZATO KIT in the United States and CHEMOSAT in Europe, gross margin commentary, and discussions of non-GAAP measures such as adjusted EBITDA. The company also issues releases on capital allocation and corporate actions, such as authorization of share repurchase programs and equity inducement grants under stock incentive plans.
A significant portion of Delcath’s news flow centers on clinical and scientific developments. Recent announcements describe subgroup analyses from the Phase 3 FOCUS study of Melphalan/Hepatic Delivery System in unresectable metastatic uveal melanoma, the Phase 2 CHOPIN trial evaluating CHEMOSAT with ipilimumab and nivolumab, real-world evidence from retrospective analyses of metastatic uveal melanoma patients, and a 10-year single-center experience with CHEMOSAT in liver-dominant disease. The company also highlights expert narrative reviews discussing PHP with melphalan using HEPZATO KIT, including patient selection, technique, and outcomes.
Additional updates include participation in investor conferences and scheduling of earnings calls, providing context for how Delcath communicates with the capital markets. For users tracking DCTH, this page offers a centralized view of regulatory, clinical, and financial news that shapes the company’s progress in liver-directed oncology therapies. Bookmark this feed to monitor new data releases, product-related publications, and ongoing disclosures from Delcath Systems Inc.
Delcath Systems, Inc. (NASDAQ: DCTH) announced the FDA has accepted its resubmission of a new drug application for the HEPZATO™ Kit, aimed at treating unresectable hepatic-dominant metastatic ocular melanoma. This acceptance is deemed a complete class 2 response, with a PDUFA date set for August 14, 2023. The HEPZATO Kit combines melphalan and a hepatic delivery system to optimize cancer treatment while minimizing systemic exposure. The CEO expressed optimism regarding the potential approval of HEPZATO as a significant treatment option for patients. However, the drug’s efficacy has yet to be established in the U.S.
Delcath Systems (NASDAQ: DCTH) has appointed John R. Sylvester as its new Chairman, succeeding Dr. Roger Stoll, who has served since October 2015. Sylvester, a director since July 2019, brings extensive experience in interventional oncology, previously leading Curium's SPECT and International business units. Dr. Stoll will remain on the board. CEO Gerard Michel highlighted Sylvester's commercial expertise as the company prepares for the US launch of its HEPZATO Kit, which recently underwent a new drug application resubmission to the FDA for treating unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, Inc. (NASDAQ: DCTH) has resubmitted a New Drug Application (NDA) to the FDA for the HEPZATO™ Kit, aimed at treating unresectable hepatic-dominant metastatic ocular melanoma (mOM). This action addresses the issues raised in a Complete Response Letter from September 2013. A decision from the FDA is anticipated within 30 days. The NDA includes data from the FOCUS trial, showing a 36.3% overall response rate and a median overall survival of 20.53 months among treated patients. The HEPZATO Kit employs a unique delivery system designed to minimize systemic exposure to the drug while effectively targeting liver tumors.
Delcath Systems, Inc. (NASDAQ: DCTH) is set to participate in the BTIG MedTech, Digital Health, Life Sciences, & Diagnostics Tools Conference from February 14 to 16, 2023, in Snowbird, Utah. CEO Gerard Michel will hold one-on-one meetings during the event. The company specializes in treating primary and metastatic liver cancers, utilizing its percutaneous hepatic perfusion (PHP) system to deliver high-dose chemotherapy while minimizing side effects. In the U.S., the PHP system is under development as HEPZATO™ KIT for metastatic ocular melanoma, while in Europe, it's marketed as CHEMOSAT.
Delcath Systems, Inc. (DCTH) has published updated results from the Phase 1b CHOPIN Trial for treating advanced uveal melanoma with a combination of Delcath's CHEMOSAT and immune checkpoint inhibitors ipilimumab and nivolumab. The study, conducted at Leiden University Medical Center, showed a median progression-free survival (PFS) of 29.1 months, with all seven patients still alive at follow-up. The trial has demonstrated an 85.7% objective response rate and a 100% disease control rate. The ongoing Phase 2 part of the trial aims to further validate these findings with 76 additional patients enrolled.
Delcath Systems, Inc. (Nasdaq: DCTH) announced the granting of an equity award as an inducement for employment to an individual. The award consists of 12,500 shares of common stock outside its 2020 Stock Incentive Plan, with an exercise price equal to the closing stock price on the grant date. A third of the options will vest after one year, with the remainder vesting monthly over two years. This action complies with NASDAQ Listing Rule 5635(c)(4). Delcath specializes in interventional oncology for liver cancers, notably using the PHP system for treating unresectable hepatic-dominant metastatic ocular melanoma.
Delcath Systems, Inc. (Nasdaq: DCTH) has successfully closed a private placement, raising approximately $6.2 million. The placement involved issuing 1,448,889 shares of common stock at $2.90 per share, and 692,042 pre-funded warrants at $2.89, with an exercise price of $0.01. Proceeds will be used for working capital and corporate purposes. The securities sold are unregistered and Delcath plans to file for registration with the SEC. The company is focused on treating liver cancers via its proprietary PHP system, known as HEPZATO in the U.S. and CHEMOSAT in Europe.
Delcath Systems, Inc. (Nasdaq: DCTH) has announced a private placement transaction, raising approximately $6.2 million. The company will issue 1,448,889 shares of common stock at $2.90 per share, or 692,042 pre-funded warrants at $2.89 each. The proceeds will support working capital and other corporate needs. The issuance is not registered under the Securities Act and is subject to customary closing conditions. Delcath specializes in treating liver cancers with its proprietary PHP system, marketed as HEPZATO in the U.S. and CHEMOSAT in Europe.
Delcath Systems announces findings from a study showing that CHEMOSAT is a promising treatment for patients with advanced cholangiocarcinoma (CCA). Conducted on 17 patients, the study revealed a 25% overall response rate and a 75% disease control rate after 42 PHP procedures. The median survival post-treatment was 9.9 months, significantly longer than traditional options. While treatment presented minor and manageable side effects, the results affirm PHP’s potential in extending life for inoperable cases, making it a valuable palliative option.
Delcath Systems (Nasdaq: DCTH) announced the granting of equity awards as an inducement for employment to two individuals. A total of 40,000 shares of common stock were issued, with an exercise price based on the closing stock price on the grant date. The vesting schedule includes one-third of the options vesting on the first anniversary, followed by equal monthly installments over 24 months. These awards comply with NASDAQ Listing Rule 5635(c)(4) and were made per the company's amended stock incentive plan.