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, known by the stock symbol DCTH, announced its participation in the H.C. Wainwright BIOCONNECT 2021 Virtual Conference, offering on-demand access to their presentation. The company focuses on interventional oncology, specifically targeting rare liver cancers with its investigational product, HEPZATO KIT. This product seeks to deliver high-dose chemotherapy directly to the liver while minimizing systemic exposure and side effects. While HEPZATO KIT is not FDA-approved yet, its European counterpart, CHEMOSAT, has been utilized at major medical centers.
Delcath Systems (DCTH) completed a public offering of 1,679,031 shares at $13.25 per share, raising approximately $22.2 million in gross proceeds. The offering involved the full exercise of an underwriter option for additional shares. The funds will support the FOCUS Clinical Trial for metastatic ocular melanoma, regulatory preparations for the HEPZATO KIT, and other corporate purposes. The SEC has accepted a shelf registration statement for these securities. Delcath is focused on innovative oncology solutions for liver cancers.
Delcath Systems, Inc. (Nasdaq: DCTH) has announced a public offering of 1,460,027 shares at $13.25 per share, aiming to raise approximately $19.3 million. The offering is set to close around December 11, 2020. Proceeds will fund the FOCUS Clinical Trial for Hepatic Dominant Ocular Melanoma, regulatory preparations for the HEPZATO KIT, and support the commercial launch of HEPZATO. The company focuses on treating liver cancers using its investigational product HEPZATO, which administers high-dose chemotherapy directly to the liver.
Delcath Systems, Inc. (DCTH) announced plans for an underwritten public offering of its common stock, subject to market conditions. The offering is planned to fund the FOCUS Clinical Trial for Hepatic Dominant Ocular Melanoma, regulatory preparations for the HEPZATO™ KIT, and the commercial launch of HEPZATO. Additionally, proceeds will support ongoing clinical development and general corporate purposes. The underwriters may purchase an additional 15% of shares sold. The company's stock has been active following the announcement, reflecting investor interest.
Delcath Systems (NASDAQ: DCTH) announced the appointment of Kevin Muir as Vice President of Commercial Operations, effective immediately. Muir has a strong background in interventional oncology, having previously helped grow BTG's sales from $40 million to $180 million. Delcath's CEO, Gerard Michel, highlighted Muir's experience as a key asset for the anticipated launch of HEPZATO, pending FDA approval. The company expects topline data from the pivotal FOCUS trial in early 2021, with a potential NDA resubmission and U.S. launch in 2022.
Delcath Systems reported its Q3 2020 results, highlighting key advancements in its interventional oncology business. The FDA conditionally accepted the name HEPZATO™ KIT for its treatment option. In the FOCUS trial, 91 patients received treatment, with topline data expected in early 2021. The executive team was bolstered by Gerard Michel's appointment as CEO. Product revenue increased to $340K from $216K year-over-year. Operating expenses decreased to $5.3 million, while net loss improved to $5.0 million compared to $7.5 million in Q3 2019. Cash reserves stood at $11.1 million.
Delcath Systems announces management participation in the Oppenheimer Fall MedTech Summit on November 12, 2020, focusing on liver-directed treatments for cancer. The interventional oncology company, trading under NASDAQ symbol DCTH, is known for its investigational product, Melphalan Hydrochloride, designed for high-dose chemotherapy delivery via the Delcath Hepatic Delivery System (Melphalan/HDS). While not FDA-approved in the U.S., the system is marketed in Europe as Delcath CHEMOSAT and demonstrates ongoing efficacy studies for various liver cancers.
Delcath Systems, Inc. (NASDAQ: DCTH) announced a conference call on November 11, 2020, at 8:30 AM ET to discuss its third quarter results for the period ending September 30, 2020. The call can be joined via phone or online streaming. Delcath focuses on liver-directed treatments for cancer, utilizing its investigational product, Melphalan Hydrochloride with the Delcath Hepatic Delivery System. The product is currently undergoing the Phase 3 FOCUS Trial for treating hepatic-dominant ocular melanoma, although it has not yet received FDA approval for the U.S. market.
Delcath Systems, Inc. (NASDAQ: DCTH) announced a 72% overall response rate in a prospective phase II study for patients with metastatic ocular melanoma confined to the liver. The study utilized the CHEMOSAT Hepatic Delivery System with Melphalan, showing a median overall survival of 19.1 months. The findings will be discussed during a KOL call on November 5, 2020, with Dr. Mark Burgmans from Leiden University Medical Center. Notably, while grade 3 or 4 hematologic events were common, they were manageable with no treatment-related deaths reported.
Delcath Systems, Inc. (NASDAQ: DCTH) appointed Gerard Michel as the new CEO effective October 1, 2020, succeeding John Purpura, who becomes COO. Michel, with over 30 years in the pharmaceutical industry, previously served at Vericel Corporation, contributing to its growth into a commercial leader. He aims to advance Delcath's Melphalan/HDS product for treating metastatic ocular melanoma, targeting a New Drug Application resubmission in mid-2021. The company also granted Michel stock options to align his interests with shareholder value.