PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN) has presented long-term follow-up data from its OLYMPUS trial, indicating sustained effectiveness of its FDA-approved treatment JELMYTO (mitomycin) for pyelocalyceal solution in patients with low-grade upper tract urothelial cancer (LG-UTUC). The study, published in the Journal of Urology, reports a median duration of response (DOR) of 47.8 months in patients who achieved a complete response to the treatment.
The findings are significant as they suggest that JELMYTO may offer a durable treatment option for LG-UTUC, aligning with current recommendations by the American Urological Association (AUA) and Society of Urological Oncology (SUO) to prioritize kidney-sparing techniques in managing the disease.
In the OLYMPUS trial, out of 71 participants, 41 achieved complete response following JELMYTO treatment. The median follow-up period was 28.1 months, and the study highlighted the potential for extended control of the disease without immediate relapse.
Dr. Phillip Pierorazio, a member of the AUA/SUO UTUC Guideline Committee and one of the study authors, underscored the importance of the results for providing evidence of JELMYTO's extended durability and the potential for maintaining recurrence-free intervals.
UroGen Pharma's Chief Medical (TASE:PMCN) Officer, Dr. Mark Schoenberg, expressed optimism regarding the favorable long-term durability of JELMYTO, which aligns with the goal of managing relapse and preserving organ function in LG-UTUC patients, who generally face a low risk of disease progression.
Despite the positive outcomes, the study acknowledges limitations, including its post-hoc nature and the selection bias of the long-term follow-up cohort.
UroGen Pharma is further exploring JELMYTO's potential through the uTRACT Registry, aiming to collect real-world usage data. As of July 10, 191 patients have been enrolled across 19 activated sites.
JELMYTO is designed to be a kidney-sparing therapeutic option for adult patients with LG-UTUC. It is a mitomycin-containing reverse thermal gel that transitions from liquid to semi-solid at body temperature, allowing for prolonged exposure of the urinary tract tissue to the medication.
Upper tract urothelial cancer, a subset of urothelial cancer, accounts for 5-10% of primary urothelial cancers and presents limited treatment options, often leading to high recurrence rates.
This information is based on a press release statement from UroGen Pharma Ltd.
In other recent news, UroGen Pharma reported its third quarter financial results and provided a business update in a recent earnings call. The company highlighted its ongoing commercialization of JELMYTO and the potential future activities for UGN-102. UroGen is actively involved in clinical trials and expects regulatory filings and decisions in the near future. UGN-102 is anticipated to be a significant growth driver upon approval.
The company has provided financial guidance for 2024, indicating its expected financial trajectory. UroGen expressed confidence in the ongoing commercialization efforts for JELMYTO and is optimistic about the approval and commercial potential of UGN-102. These developments are part of the company's strategy to drive future success through expanding its commercialization efforts and advancing its clinical trials.
InvestingPro Insights
UroGen Pharma's (NASDAQ: URGN) recent presentation of long-term follow-up data for JELMYTO aligns with the company's strong market position in the urothelial cancer treatment space. According to InvestingPro data, UroGen boasts impressive gross profit margins of 90.27% for the last twelve months as of Q3 2023, reflecting the potential profitability of its innovative treatments like JELMYTO.
The company's focus on kidney-sparing techniques is particularly noteworthy given its current financial position. InvestingPro Tips reveal that UroGen holds more cash than debt on its balance sheet, providing financial flexibility to continue its research and development efforts. This solid financial footing is crucial as the company works to expand the real-world usage data for JELMYTO through initiatives like the uTRACT Registry.
Despite the positive clinical outcomes, investors should note that UroGen is not yet profitable over the last twelve months. However, the company's revenue growth of 15.64% in the same period suggests progress in commercializing its treatments. For those considering an investment in UroGen, it's worth noting that InvestingPro offers 10 additional tips for a more comprehensive analysis of the company's financial health and market position.
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