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Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.
HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.
In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.
Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.
Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.
As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.
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.
Delcath Systems, focused on liver-directed treatments, announced its participation in two investor conferences. The first is the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 4:30 PM EDT, featuring a live webcast. The second event is the Oppenheimer Fall Healthcare Life Science & Med Tech Summit on September 23, 2020. Virtual one-on-one meetings with management can be scheduled. Delcath's investigational product, Melphalan Hydrochloride for Injection, targets liver cancer treatment and has not yet received FDA approval.
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