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 (NASDAQ: DCTH) specializes in innovative liver cancer therapies through its proprietary drug-device combination. This page provides investors and medical professionals with direct access to all official company announcements, including clinical trial milestones, regulatory updates, and strategic partnerships.
Discover the latest developments in Delcath's hepatic delivery system and melphalan hydrochloride treatments. Our curated news collection features FDA communications, European commercialization progress, and peer-reviewed research findings – essential resources for understanding the company's position in interventional oncology.
Key updates on: Clinical trial phases | Regulatory approvals | Financial results | Medical conference presentations | Partnership announcements. Bookmark this page to monitor Delcath's advancements in targeted chemotherapy delivery and liver cancer treatment protocols.
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.
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.