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QUEENSBURY, N.Y. - Delcath Systems, Inc. (NASDAQ:DCTH), a $404 million market cap company specializing in interventional oncology with impressive revenue growth of over 1,700% in the last twelve months, has received clearance from the U.S. Food and Drug Administration (FDA) to begin patient enrollment in the United States for its Phase 2 clinical trial. According to InvestingPro data, the company maintains a strong gross profit margin of 83% and holds more cash than debt on its balance sheet. This trial will assess the safety and efficacy of HEPZATO™, used in combination with standard of care (SOC), for patients with liver-dominant metastatic breast cancer (mBC) who are HER2-negative.
The trial follows the failure of previous treatments and will compare the use of HEPZATO™ with SOC against SOC alone. The SOC treatments include eribulin, vinorelbine, or capecitabine, at the discretion of the physician. The study aims to enroll approximately 90 patients and will take place across more than 20 sites in the United States and Europe. Enrollment is expected to begin in the fourth quarter of 2025. With the stock trading at $12.11, analysts maintain a strong buy consensus with price targets ranging from $21 to $25, suggesting significant upside potential. For detailed analysis and additional insights, check out the comprehensive Pro Research Report available on InvestingPro.
Delcath’s management estimates that around 7,000 patients in the United States annually could benefit from this third-line treatment for HER2-negative mBC with liver metastases. The primary endpoint of the trial is hepatic progression-free survival, with results anticipated by the end of 2028. Overall survival, a secondary endpoint, is expected to be reported in 2029.
The CEO of Delcath Systems, Gerard Michel, expressed optimism about the trial’s potential to bring new treatment options to patients with limited alternatives and to demonstrate the broader applications of HEPZATO™ for liver-dominant cancers.
Delcath’s proprietary product, HEPZATO KIT™, which includes the chemotherapeutic drug melphalan and Delcath’s Hepatic Delivery System (HDS), is designed to deliver high-dose chemotherapy to the liver while minimizing systemic exposure and side effects. In the United States, the HEPZATO KIT™ is approved for adult patients with metastatic uveal melanoma (mUM) with specific criteria.
In Europe, the HDS is approved as a Class III medical device under the name CHEMOSAT®, for the treatment of a range of liver cancers.
The information in this article is based on a press release statement from Delcath Systems, Inc. The company cautions that the forward-looking statements included in the release are subject to risks and uncertainties, which could affect the trial’s timeline and outcomes. InvestingPro analysis shows the company maintains a healthy financial position with a current ratio of 12.01, indicating strong liquidity. InvestingPro subscribers have access to over 8 additional key insights and metrics about Delcath Systems, along with real-time updates and expert analysis.
In other recent news, Delcath Systems reported a substantial quarter-over-quarter revenue growth of 35% for the fourth quarter of 2024, with total revenue reaching $15.1 million, exceeding the forecast of $13.62 million. However, the company posted an earnings per share (EPS) of -$0.11, missing the forecast of $0. This mixed performance impacted investor sentiment, as reflected in the stock’s premarket decline. Delcath activated three new treatment sites in the fourth quarter and has added two more since the beginning of 2025, bringing the total to 16 centers. Analysts at H.C. Wainwright and BTIG expressed optimism about Delcath’s growth prospects, with both firms raising their price targets to $24 and $22 respectively, while maintaining Buy ratings. Delcath also awarded stock options to six new employees as part of their compensation plan, aiming to attract and retain top talent. Meanwhile, Beta Bionics announced the appointment of Gerard Michel, Delcath’s CEO, to its board of directors, highlighting his extensive experience in the pharmaceutical and medical technology sectors. These developments reflect the ongoing strategic initiatives and expansions by both companies.
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