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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) 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.
Delcath Systems (NASDAQ: DCTH) announced positive preliminary results from the Phase 3 FOCUS trial of HEPZATO KIT for treating liver-dominant metastatic ocular melanoma. A preliminary analysis showed an Overall Response Rate (ORR) of 29.2%, significantly exceeding the required 21.0% threshold for superiority over checkpoint inhibitors. This analysis covered 87% of enrolled patients and demonstrates the drug's efficacy, with a lower bound of 20.1% surpassing the 8.3% upper limit of prior studies. Delcath aims to address liver cancers with its innovative system.
Delcath Systems (NASDAQ: DCTH) announced fourth quarter 2020 results and business highlights on March 31, 2021. The company reported positive preliminary outcomes from the FOCUS Clinical Trial for Hepatic Dominant Ocular Melanoma, with an overall response rate exceeding expectations. Despite a 5% decrease in product revenue to $379K, total cash reserves rose to $28.8 million. The net loss for Q4 2020 was $7 million, a reversal from net income of $12.5 million in Q4 2019. Delcath also strengthened its executive team and completed a public offering, raising $22.2 million.
Delcath Systems (NASDAQ: DCTH) announced encouraging preliminary results from its Phase 3 FOCUS trial of HEPZATO KIT for liver dominant metastatic ocular melanoma, demonstrating an Overall Response Rate (ORR) of 29.2%, surpassing the predefined threshold of 21.0%. Key findings include a median Progression Free Survival of 9.0 months versus 3.1 months for Best Alternative Care (BAC), and a Disease Control Rate of 70.9%. The safety profile aligns with previous studies, noting no new safety signals. Full datasets are anticipated to further evaluate HEPZATO's efficacy and impact on regulatory submissions.
Delcath Systems, Inc. (DCTH) will host a conference call on March 31, 2021, at 8:00 AM Eastern Time to discuss its fourth quarter results for the period ended December 31, 2020. Participants can join by dialing in 5 to 10 minutes early. The company focuses on treating rare liver cancers using its investigational product, HEPZATO KIT, which is designed for high-dose chemotherapy delivery. While CE Marked in Europe as CHEMOSAT, it is not yet approved by the FDA for U.S. sales.
Delcath Systems (DCTH) announced its participation in two upcoming virtual investor conferences. The HC Wainwright Global Life Sciences Conference will occur on March 9, 2021, with on-demand viewing starting at 7:00 AM (ET). A webcast link is available for attendees. Additionally, Delcath will attend the 33rd Annual Roth Conference, scheduled for March 15-17, 2021, allowing for 1x1 meetings only. Delcath focuses on oncology treatments for liver cancers, with its investigational product, HEPZATO KIT, targeting high-dose chemotherapy treatment.
Delcath Systems (DCTH), an interventional oncology firm, has announced its participation in upcoming virtual investor conferences. Notable events include the BTIG Virtual MedTech Conference on February 18 at 1:00 PM ET and the SVB Leerink's Annual Global Healthcare Conference from February 22 to 26, which will consist of one-on-one meetings only. The company's investigational product, HEPZATO KIT, targets rare liver cancers. It is currently not FDA-approved in the U.S. but is marketed in Europe as CHEMOSAT, where it has received CE Mark certification.
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.
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