Delcath Publishes FOCUS Study Subgroup Analysis Results, Demonstrating Significant Efficacy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
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Source: Newsfilter
- Efficacy Analysis: The subgroup analysis from the FOCUS study reveals that patients with tumor burden below the median had an overall response rate (ORR) of 51.1%, significantly higher than 22.2% (p=0.008), indicating the critical importance of early intervention for optimizing treatment outcomes.
- Survival Extension: Patients with tumor burden below the median exhibited a median progression-free survival (PFS) of 11.3 months, significantly longer than 5.8 months (p=0.007), providing essential evidence for clinical treatment strategies.
- Safety Consistency: Safety data across subgroups showed that the incidence of serious adverse events was consistent with the overall study population, with no treatment-related deaths, indicating the manageability and applicability of this therapy.
- Clinical Significance: Delcath's Chief Medical Officer emphasized that these analyses highlight the importance of early intervention in patients with lower tumor burden to maximize clinical benefits, further validating the HEPZATO KIT as a key treatment option.
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Analyst Views on DCTH
Wall Street analysts forecast DCTH stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for DCTH is 24.20 USD with a low forecast of 18.00 USD and a high forecast of 30.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 9.910
Low
18.00
Averages
24.20
High
30.00
Current: 9.910
Low
18.00
Averages
24.20
High
30.00
About DCTH
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. HEPZATOTM KIT is a drug/device combination product. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and the Company’s proprietary Hepatic Delivery System (HDS). In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan. In the United States, HEPZATO is regulated as a drug by the United States Food and Drug Administration (FDA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Delcath Systems Reports Preliminary 2025 Revenue of $85.2 Million
- Revenue Growth: Delcath anticipates fourth quarter and full-year 2025 revenues of approximately $20.7 million and $85.2 million, indicating sustained growth potential in the liver cancer treatment sector.
- HEPZATO KIT Performance: Expected revenues for HEPZATO KIT are around $19.0 million and $78.8 million, reflecting strong market demand for the product and further solidifying Delcath's position in liver cancer treatment.
- Share Buyback Program: As of December 31, 2025, the company repurchased 628,572 common shares for $6.0 million, demonstrating confidence in its own value and creating shareholder returns.
- Clinical Trial Progress: HEPZATO procedure volume grew approximately 140% in 2025, showcasing the company's success in promoting new treatment options, which is expected to drive future revenue growth.
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Three Microcap Companies Show Healthy Growth: OPXS, DCTH, MAMA
- OPXS Business Growth: Optex Systems Holdings is experiencing rising revenue and expanding margins through the design and manufacture of advanced optical sighting systems, indicating stable demand and financial health in the defense market.
- DCTH Business Transformation: Delcath Systems is commercializing its FDA-approved liver cancer treatment, with revenue gradually increasing, marking a successful transition from development to execution and addressing a serious medical need.
- MAMA Expansion Momentum: Mama's Creations is growing revenue at a healthy pace through fresh food sales in supermarkets and club stores nationwide, while maintaining operational leverage and balance sheet discipline, showcasing sustainable growth potential.
- Common Traits: All three companies are improving financial quality alongside revenue growth, indicating their long-term investment value in the microcap market, quietly strengthening while the market is distracted.
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