Delcath Systems' M-PHP Included in New Guidelines
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 06 2026
0mins
Should l Buy DCTH?
Delcath Systems announced that its proprietary CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO-EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up. M-PHP is also recognized in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Metastatic Uveal Melanoma. HEPZATO KIT is included as a Category 2A recommended treatment option for appropriate patients with hepatic-dominant metastatic uveal melanoma. M-PHP has been listed as a liver-directed therapy option in NCCN guidelines for several years, predating the 2023 FDA approval of HEPZATO KIT.
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Analyst Views on DCTH
Wall Street analysts forecast DCTH stock price to rise
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 10.640
Low
18.00
Averages
24.50
High
30.00
Current: 10.640
Low
18.00
Averages
24.50
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 to Host Q1 2026 Earnings Call on May 7
- Earnings Call Announcement: Delcath Systems, Inc. will host an earnings call on May 7, 2026, at 8:30 AM Eastern Time to discuss its Q1 results ending March 31, 2026, which is expected to provide investors with insights into the latest financial performance and business developments.
- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call, with toll-free number 1-800-717-1738 for U.S. and international number 1-646-307-1865, ensuring timely access to critical information for investors.
- Webcast and Replay: The event will be available via webcast, allowing investors to join through the provided link, and a replay will be accessible shortly after the call, enabling those unable to attend live to catch up on the discussion.
- Company Overview: Delcath Systems focuses on interventional oncology for liver cancer treatment, with its HEPZATO KIT and CHEMOSAT systems designed to deliver high-dose chemotherapy while minimizing systemic exposure and side effects, showcasing potential in treating metastatic liver cancers.
See More
Delcath's M-PHP Therapy Recognized in ESMO Guidelines
- Therapy Recognition: Delcath Systems' CHEMOSAT® Hepatic Delivery System has been included in the ESMO–EURACAN Clinical Practice Guidelines as a recommended liver-directed regional therapy option, highlighting its significance in treating liver-dominant metastatic uveal melanoma (mUM).
- Clinical Trial Support: M-PHP is supported by two key Phase 3 trials (NCT02678572 and NCT00324727) demonstrating improved hepatic and overall progression-free survival, further solidifying its position in treatment protocols.
- Treatment Classification: The HEPZATO KIT™ is classified as a Category 2A recommended treatment option for suitable patients, emphasizing its potential application in hepatic-dominant metastatic uveal melanoma, particularly in cases with limited effective treatment options.
- Market Impact: With up to 90% of mUM patients developing liver metastases, the recognition in ESMO guidelines not only enhances Delcath's market position but also provides robust support for its role in multidisciplinary care.
See More
Delcath Systems to Showcase at 2026 SIR Annual Meeting
- Conference Participation: Delcath Systems will attend the Society of Interventional Radiology Annual Meeting from April 11-15, 2026, in Toronto, Canada, showcasing its treatment solutions for liver cancer, thereby enhancing its visibility in the interventional oncology field.
- Product Showcase: The Hepatic Delivery System will be featured in three presentations during the event, which is expected to attract significant attention from medical professionals, potentially driving market demand and product recognition.
- Expert Presentations: On April 13, Dr. Eric Wehrenberg-Klee from Massachusetts General Hospital will discuss his HEPZATO user experience at the Innovation Hub, further validating the clinical application of the product and boosting investor confidence.
- Clinical Experience Sharing: On April 15, Dr. David Eschelman from Thomas Jefferson University and Dr. Mustafa Ege Seker from the University of Wisconsin will present their preliminary clinical experiences with HEPZATO KIT for liver metastases from uveal melanoma, showcasing its effectiveness and potentially promoting future sales growth.
See More
Delcath Systems Reports Record Revenue and Growth in Q4 2025
- Significant Revenue Growth: Delcath Systems achieved over 40% volume growth in 2025, with total revenue reaching $85.2 million, including $20.7 million in Q4, indicating strong market performance and sustained growth potential.
- Treatment Center Expansion Plan: The company aims to increase the number of active treatment centers from 28 to 40 by the end of 2026, with an anticipated acceleration in activations in the second half of the year, which will enhance market coverage and customer service capabilities.
- Increased R&D and Operating Expenses: R&D expenses are expected to rise by nearly 90% in 2026, while SG&A expenses will increase by nearly 50%, reflecting the company's intent to invest in clinical and commercial expansions to support future growth.
- Improved Cash Flow and Profitability: The net income for 2025 was $2.7 million, a significant improvement from a loss of $26.4 million in 2024, with approximately $91 million in cash and investments at year-end, demonstrating robust financial health and positive operating cash flow trends.
See More
Delcath Systems Q4 Earnings Exceed Expectations
- Earnings Performance: Delcath Systems reported a Q4 GAAP EPS of -$0.05, missing expectations by $0.01, yet revenue reached $20.73 million, reflecting a 37.3% year-over-year increase and exceeding estimates by $0.05 million, indicating strong growth potential in the market.
- HEPZATO KIT Revenue: The HEPZATO KIT™ generated $19.0 million in Q4 revenue and $78.8 million for the full year, demonstrating sustained market demand for this product line, which is expected to drive future revenue growth.
- CHEMOSAT Revenue: CHEMOSAT® contributed $1.7 million in Q4 revenue and $6.4 million for the full year, providing a stable foundation for overall company revenue despite being relatively small, reflecting the product's market acceptance.
- Future Outlook: The company anticipates total revenue of at least $100 million for fiscal year 2026, with HEPZATO KIT volume expected to increase by at least 20% over 2025, while gross margins are projected to range between 84% and 87%, showcasing confidence in future growth.
See More
Delcath Systems to Announce Q4 Earnings on February 26
- Earnings Announcement: Delcath Systems (DCTH) is set to announce its Q4 earnings on February 26 before market open, with consensus EPS estimate at -$0.03 and revenue expected at $20.68 million, representing a 37% year-over-year increase.
- Stable Earnings Performance: Over the past year, DCTH has met EPS estimates 50% of the time and revenue estimates 50% of the time, indicating a consistent performance in earnings capability.
- Upward Revision Trend: In the last three months, EPS estimates have seen two upward revisions with no downward adjustments, while revenue estimates have experienced three upward revisions, reflecting increased market confidence in the company's future performance.
- Annual Revenue Outlook: Delcath Systems anticipates FY 2023 revenue of $85.2 million, highlighting the company's growth potential and positive outlook for business expansion in the market.
See More
Delcath Systems to Host Q1 2026 Earnings Call on May 7
- Earnings Call Announcement: Delcath Systems, Inc. will host an earnings call on May 7, 2026, at 8:30 AM Eastern Time to discuss its Q1 results ending March 31, 2026, which is expected to provide investors with insights into the latest financial performance and business developments.
- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call, with toll-free number 1-800-717-1738 for U.S. and international number 1-646-307-1865, ensuring timely access to critical information for investors.
- Webcast and Replay: The event will be available via webcast, allowing investors to join through the provided link, and a replay will be accessible shortly after the call, enabling those unable to attend live to catch up on the discussion.
- Company Overview: Delcath Systems focuses on interventional oncology for liver cancer treatment, with its HEPZATO KIT and CHEMOSAT systems designed to deliver high-dose chemotherapy while minimizing systemic exposure and side effects, showcasing potential in treating metastatic liver cancers.
See More
Delcath's M-PHP Therapy Recognized in ESMO Guidelines
- Therapy Recognition: Delcath Systems' CHEMOSAT® Hepatic Delivery System has been included in the ESMO–EURACAN Clinical Practice Guidelines as a recommended liver-directed regional therapy option, highlighting its significance in treating liver-dominant metastatic uveal melanoma (mUM).
- Clinical Trial Support: M-PHP is supported by two key Phase 3 trials (NCT02678572 and NCT00324727) demonstrating improved hepatic and overall progression-free survival, further solidifying its position in treatment protocols.
- Treatment Classification: The HEPZATO KIT™ is classified as a Category 2A recommended treatment option for suitable patients, emphasizing its potential application in hepatic-dominant metastatic uveal melanoma, particularly in cases with limited effective treatment options.
- Market Impact: With up to 90% of mUM patients developing liver metastases, the recognition in ESMO guidelines not only enhances Delcath's market position but also provides robust support for its role in multidisciplinary care.
See More
Delcath Systems to Showcase at 2026 SIR Annual Meeting
- Conference Participation: Delcath Systems will attend the Society of Interventional Radiology Annual Meeting from April 11-15, 2026, in Toronto, Canada, showcasing its treatment solutions for liver cancer, thereby enhancing its visibility in the interventional oncology field.
- Product Showcase: The Hepatic Delivery System will be featured in three presentations during the event, which is expected to attract significant attention from medical professionals, potentially driving market demand and product recognition.
- Expert Presentations: On April 13, Dr. Eric Wehrenberg-Klee from Massachusetts General Hospital will discuss his HEPZATO user experience at the Innovation Hub, further validating the clinical application of the product and boosting investor confidence.
- Clinical Experience Sharing: On April 15, Dr. David Eschelman from Thomas Jefferson University and Dr. Mustafa Ege Seker from the University of Wisconsin will present their preliminary clinical experiences with HEPZATO KIT for liver metastases from uveal melanoma, showcasing its effectiveness and potentially promoting future sales growth.
See More
Delcath Systems Reports Record Revenue and Growth in Q4 2025
- Significant Revenue Growth: Delcath Systems achieved over 40% volume growth in 2025, with total revenue reaching $85.2 million, including $20.7 million in Q4, indicating strong market performance and sustained growth potential.
- Treatment Center Expansion Plan: The company aims to increase the number of active treatment centers from 28 to 40 by the end of 2026, with an anticipated acceleration in activations in the second half of the year, which will enhance market coverage and customer service capabilities.
- Increased R&D and Operating Expenses: R&D expenses are expected to rise by nearly 90% in 2026, while SG&A expenses will increase by nearly 50%, reflecting the company's intent to invest in clinical and commercial expansions to support future growth.
- Improved Cash Flow and Profitability: The net income for 2025 was $2.7 million, a significant improvement from a loss of $26.4 million in 2024, with approximately $91 million in cash and investments at year-end, demonstrating robust financial health and positive operating cash flow trends.
See More
Delcath Systems Q4 Earnings Exceed Expectations
- Earnings Performance: Delcath Systems reported a Q4 GAAP EPS of -$0.05, missing expectations by $0.01, yet revenue reached $20.73 million, reflecting a 37.3% year-over-year increase and exceeding estimates by $0.05 million, indicating strong growth potential in the market.
- HEPZATO KIT Revenue: The HEPZATO KIT™ generated $19.0 million in Q4 revenue and $78.8 million for the full year, demonstrating sustained market demand for this product line, which is expected to drive future revenue growth.
- CHEMOSAT Revenue: CHEMOSAT® contributed $1.7 million in Q4 revenue and $6.4 million for the full year, providing a stable foundation for overall company revenue despite being relatively small, reflecting the product's market acceptance.
- Future Outlook: The company anticipates total revenue of at least $100 million for fiscal year 2026, with HEPZATO KIT volume expected to increase by at least 20% over 2025, while gross margins are projected to range between 84% and 87%, showcasing confidence in future growth.
See More
Delcath Systems to Announce Q4 Earnings on February 26
- Earnings Announcement: Delcath Systems (DCTH) is set to announce its Q4 earnings on February 26 before market open, with consensus EPS estimate at -$0.03 and revenue expected at $20.68 million, representing a 37% year-over-year increase.
- Stable Earnings Performance: Over the past year, DCTH has met EPS estimates 50% of the time and revenue estimates 50% of the time, indicating a consistent performance in earnings capability.
- Upward Revision Trend: In the last three months, EPS estimates have seen two upward revisions with no downward adjustments, while revenue estimates have experienced three upward revisions, reflecting increased market confidence in the company's future performance.
- Annual Revenue Outlook: Delcath Systems anticipates FY 2023 revenue of $85.2 million, highlighting the company's growth potential and positive outlook for business expansion in the market.
See More
