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.
Delcath Systems, Inc. develops interventional oncology products for primary and metastatic liver cancers. Its core products include HEPZATO KIT, a melphalan and Hepatic Delivery System combination product approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma, and CHEMOSAT Hepatic Delivery System for Melphalan used in percutaneous hepatic perfusion.
Recurring news covers quarterly operating results, HEPZATO KIT and CHEMOSAT revenue, clinical publications from studies such as FOCUS and CHOPIN, presentations at oncology and interventional radiology meetings, guideline recognition, and studies of melphalan-based percutaneous hepatic perfusion in liver-dominant cancers. Company updates also address FDA-approved product status, European clinical practice references, and capital actions such as common-stock repurchases.
Delcath Systems, Inc. (Nasdaq: DCTH) will host a conference call on August 10, 2021, at 8:30 AM ET to discuss its second-quarter results for the period ending June 30, 2021. The call will be accessible via phone and online. Delcath focuses on providing innovative treatments for rare liver cancers through its proprietary PHP system, which allows high-dose chemotherapy directly to the liver, minimizing systemic side effects. In Europe, the PHP system is marketed as CHEMOSAT, while in the U.S., it is under the name HEPZATO KIT.
Delcath Systems, focused on interventional oncology for liver cancers, will present at the Access to Giving Virtual Conference on July 13, 2021, at 3 p.m. ET. CEO Gerard Michel will lead the discussion. This conference allows companies to engage with investors while supporting charitable causes. Registration is free and can be done online. Delcath’s investigational product, HEPZATO KIT, aims to deliver high-dose chemotherapy to the liver, although it is not approved by the FDA in the U.S. The system is marketed in Europe as Delcath CHEMOSAT.
Delcath Systems is set to join the Russell Microcap® Index on June 28, 2021, following the annual reconstitution. This membership will remain for one year and includes automatic inclusion in growth and value style indexes. The CEO, Gerard Michel, emphasized that this milestone enhances the company's visibility among investors. Russell indexes manage approximately $10.6 trillion in assets, being widely used by institutional investors for benchmarking. Delcath focuses on treating liver cancers using its proprietary PHP system, marketed as HEPZATO in the US and CHEMOSAT in Europe.
Delcath Systems (DCTH) reported positive preliminary results from its FOCUS Phase III trial for HEPZATO in treating liver-dominant metastatic ocular melanoma. The study achieved a significant overall response rate of 29.2%, exceeding the prespecified 8.3% threshold. Notably, 44% of patients treated with HEPZATO demonstrated a 30% or greater reduction in tumor size, compared to only 17% in the Best Alternative Care arm. The company will hold a Q&A webinar to discuss these findings further.
Delcath Systems, focused on interventional oncology, announced its management will present at the LD Micro Virtual Investor Conference on June 10, 2021, at 2:30 p.m. ET. This event will feature a live audio webcast accessible through their official link. Delcath’s investigational product, HEPZATO KIT, aims to treat primary and metastatic liver cancers by delivering high-dose chemotherapy while minimizing systemic exposure. Although not FDA-approved in the U.S., it is marketed in Europe under the CHEMOSAT name and has been CE Marked for use.
Delcath Systems (DCTH) announced management will present at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 4:00 PM (ET). The event provides a platform for showcasing Delcath's focus on treating rare primary and metastatic liver cancers using their investigational product, HEPZATO KIT, designed for high-dose chemotherapy delivery to the liver. While the HEPZATO KIT is not yet FDA-approved, it is marketed in Europe as CHEMOSAT, used in major medical centers. For more details, visit their conference page linked in the announcement.
Delcath Systems reported Q1 2021 financial results with product revenue at $0.4 million, up from $0.3 million in Q1 2020. The company posted a net loss of $6.8 million, a decline from net income of $7.9 million in the same period last year. Cash and equivalents stood at $26.7 million, significantly higher than $4.7 million a year prior. Notably, preliminary results from the FOCUS Clinical Trial show positive outcomes for HEPZATO in treating hepatic dominant ocular melanoma, with a statistically significant overall response rate exceeding the success threshold.
Delcath Systems, Inc. (DCTH) announced a conference call scheduled for May 11, 2021, to discuss its first-quarter results ending March 31, 2021. The call is set for 8:30 AM ET, and participants can join via phone or online. Delcath specializes in interventional oncology, focusing on rare liver cancers with its investigational product, HEPZATO KIT, designed for targeted chemotherapy delivery. While HEPZATO KIT is not FDA-approved in the U.S., it is CE-marked in Europe. The company has paused its ALIGN Trial for intrahepatic cholangiocarcinoma to reevaluate the trial's design.
Delcath Systems (DCTH) announces a positive oral presentation at the ASCO Annual Meeting regarding the FOCUS Phase III trial for HEPZATO in treating ocular melanoma liver metastases. The event will occur virtually from June 4-8, 2021, with Dr. Jonathan S. Zager presenting preliminary efficacy results. A Q&A webinar is also scheduled for June 7, 2021, at 8:30 AM ET, where CEO Gerard Michel will discuss the company's strategy and trial outcomes. HEPZATO aims to improve cancer treatment by delivering high-dose chemotherapy directly to the liver, minimizing side effects.
Delcath Systems (Nasdaq: DCTH) announced a significant update from the UK’s NICE, granting CHEMOSAT Hepatic Delivery System a Special Arrangement designation. This change allows increased reimbursement options, enabling private insurance and regional funding for treatments previously limited to research studies. The revised guidance also supports national reimbursement applications. CEO Gerard Michel expressed optimism regarding the availability of CHEMOSAT for patients with liver metastases from ocular melanoma, aligning with positive preliminary results from the FOCUS trial.