JELMYTO shows long-term effectiveness in cancer study

PRINCETON, N.J. - UroGen Pharma Ltd. (NASDAQ: URGN), a biotech company focusing on urothelial and specialty cancer treatments with impressive gross profit margins of 90%, recently shared long-term study results for its FDA-approved JELMYTO (mitomycin) for pyelocalyceal solution. According to InvestingPro analysis, the company, currently valued at $432 million, appears undervalued based on its Fair Value assessment. The study, published in the March issue of The Journal of Urology, indicates a median duration of response of nearly four years in patients with low-grade upper tract urothelial cancer (LG-UTUC) who achieved a complete response using JELMYTO.

The study followed 20 of the 41 patients from the OLYMPUS trial who reached a complete response, showing a median duration of response of 47.8 months, with a median follow-up of 28.1 months. This outcome supports JELMYTO’s potential for sustained disease control. The company has demonstrated strong revenue growth of 15.6% over the last twelve months, as reported by InvestingPro, which offers 8 additional key insights about UroGen’s financial performance.

Dr. Phillip Pierorazio, Chief of Urology at Penn Presbyterian Medical (TASE:PMCN) Center, highlighted the durability of JELMYTO’s effects, while Dr. Mark Schoenberg, Chief Medical Officer of UroGen, emphasized the treatment’s alignment with key objectives for LG-UTUC, such as preventing relapse and preserving organ function.

The analysis acknowledged limitations, including its post-hoc nature and potential selection bias. Nonetheless, UroGen Pharma is continuing to investigate JELMYTO’s potential through the JELMYTO uTRACT Registry, which is collecting real-world data from 228 enrolled patients across 21 sites as of January 27, 2025.

JELMYTO, a mitomycin-containing reverse thermal gel, is designed to treat LG-UTUC in adults. It transitions from liquid to semi-solid at body temperature, allowing for sustained medication exposure in the urinary tract. With a strong liquidity position reflected in its current ratio of 9.0, UroGen maintains financial flexibility to support its commercial operations. Detailed analysis of UroGen’s financial health and growth prospects is available in the comprehensive Pro Research Report on InvestingPro.

Urothelial cancer ranks as the ninth most common cancer globally, with 5-10% of cases originating in the ureter or renal pelvis, known as UTUC. In the U.S., LG-UTUC affects approximately 6,000 to 7,000 patients annually, primarily diagnosed in individuals over 70 years old.

UroGen Pharma, headquartered in Princeton, NJ, is committed to developing innovative cancer treatments and has established RTGel reverse-thermal hydrogel as part of its sustained-release technology platform.

The information in this article is based on a press release statement from UroGen Pharma Ltd.

In other recent news, UroGen Pharma Ltd. reported encouraging results from multiple studies on its treatments for urothelial cancers. The company’s JELMYTO (mitomycin) for pyelocalyceal solution showed promising long-term disease control in patients with low-grade upper tract urothelial cancer (LG-UTUC) in a post-commercialization analysis. The study followed 56 patients, with 68% remaining free of disease recurrence after a median follow-up period of 23.5 months.

Additionally, UroGen’s UGN-102 demonstrated a high response rate in a Phase 3 ENVISION study for patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The trial achieved a 79.6% complete response rate at three months and an 82.3% duration of response at one year. In light of these findings, UroGen has completed the submission of a New Drug Application to the U.S. Food and Drug Administration for UGN-102.

Furthermore, UroGen’s OLYMPUS trial revealed the sustained efficacy of JELMYTO in LG-UTUC patients, reporting a median duration of response of 47.8 months in patients who achieved a complete response. Despite the positive outcomes, both the OLYMPUS trial and the study on JELMYTO highlight the need for additional research to confirm the long-term outcomes and safety of these treatments. These are recent developments in UroGen’s ongoing efforts to advance therapies for complex urological conditions.

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