Delcath Systems Announces Publication Of Results From Pivotal FOCUS Study In Metastatic Uveal Melanoma Patients Treated With HEPZATO KIT
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Delcath Systems, Inc. (NASDAQ:DCTH) announced the publication of positive results from the Phase 3 FOCUS study of HEPZATO KIT for treating unresectable metastatic Uveal Melanoma (mUM), showing a significantly higher overall response rate compared to historical controls. The FDA approved HEPZATO KIT based on these results. The study's findings, which include a 73.6% disease control rate and a 7.7% complete response rate, were published in the Annals of Surgical Oncology. Safety profiles were comparable to existing treatments, with no treatment-related deaths reported.
May 06, 2024 | 1:03 pm
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Delcath Systems, Inc. (DCTH) announced significant positive results from its Phase 3 FOCUS study for HEPZATO KIT, leading to FDA approval. The study's success in treating unresectable metastatic Uveal Melanoma positions HEPZATO KIT as a leading treatment option, potentially impacting Delcath's market position and future revenue positively.
The publication of positive results from the FOCUS study and subsequent FDA approval of HEPZATO KIT significantly enhances Delcath Systems' product portfolio, potentially leading to increased adoption and sales. Given the study's success and the product's positioning as the only FDA-approved liver-directed treatment for mUM, investor confidence and market perception of DCTH are likely to improve, driving positive short-term price movement.
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