UroGen’s Final Results from Olympus Five-Year Follow-Up Study Reinforces Durable Response with JELMYTO in Patients with Low-Grade Upper Tract Urothelial Cancer
PRINCETON, N.J., Oct. 28, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative therapies that treat urothelial and specialty cancers, today announced publication of final results from the Olympus long-term follow-up study in Therapeutic Advances in Urology, demonstrating the long-term durability of response with JELMYTO® (mitomycin) for pyelocalyceal solution in adult patients with low-grade upper tract urothelial cancer (LG-UTUC).
Among all 41 patients from the Olympus trial who achieved a complete response following primary chemoablation with JELMYTO (n=41), the median duration of response was 47.8 months, with a median follow-up of 28.1 months (95% CI: 13.1, 60.1). Twenty patients entered the long-term follow-up study with a median follow-up of 53.3 months (95% CI: 27.9, 72.8), and in these patients the median duration of response was not estimable (95% CI: 43.5, not estimable) due to the low event rate. As of March 2025, 75% (15/20) of patients in the long-term follow-up study remained event-free, and no progression to high-grade disease was observed.
"These five-year findings further demonstrate the long-term durability of response achieved with JELMYTO in adults with low-grade upper tract urothelial cancer," said Phillip Pierorazio, MD, Chief of Urology, Penn Presbyterian Medical Center and Professor of Surgery, Hospital of the University of Pennsylvania and lead author of the study. "The sustained disease control observed during extended follow-up provides additional evidence supporting the long-term benefits of JELMYTO."
Published in Therapeutic Advances in Urology, the five-year follow-up analysis builds upon previously published Olympus findings and provides extended follow-up of patients who achieved a complete response following treatment with JELMYTO. The publication reinforces the durability of response observed among patients who participated in the analysis.
“We are encouraged by the long-term clinical outcomes in patients who achieved a complete response following treatment with JELMYTO,” said Mark Schoenberg, MD, Chief Medical Officer, UroGen. “The publication of these five-year follow-up data supports JELMYTO as a kidney-sparing treatment option, providing patients with durable, long-lasting results. We look forward to pending real-world data regarding use of JELMYTO from the uTRACT Registry.”
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel approved for the treatment of adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through a nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
About Upper Tract Urothelial Cancer
Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the United States. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as UTUC. In the United States, there are approximately 6,000 - 7,000 new or recurrent LG-UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often have multiple comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). Treatment with endoscopic surgery can be associated with a high rate of recurrence and relapse.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product, JELMYTO (mitomycin) for pyelocalyceal solution, is approved to treat low-grade upper tract urothelial cancer, and our second product is approved for adult patients with recurrent LG-IR-NMIBC. Both products are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
How will I receive JELMYTO?
After receiving JELMYTO:
JELMYTO may cause serious side effects, including:
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the implications of the Olympus five-year follow-up study findings, including the potential long-term benefits of JELMYTO in adult patients with LG-UTUC; JELMYTO’s continued positioning as a kidney-sparing treatment option; the anticipated real-world data regarding use of JELMYTO from the uTRACT Registry; and the potential of UroGen’s RTGel platform technology to improve the therapeutic profiles of existing drugs and enable longer exposure of urinary tract tissue to medications. Words such as “may,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary clinical results may not be indicative of results that may be observed in the future; potential safety and other complications related to UroGen’s products and product candidates; risks related to our and our licensors’ ability to protect our respective patents and other intellectual property, including the fact that UroGen’s or its licensors’ pending patent applications may not be successful, and in such event, the duration of intellectual property protection would be more limited; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s RTGel technology and UroGen’s products and product candidates may not perform as expected; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. These and other risks and uncertainties are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange Commission on August 5, 2026. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@urogen.com
(609) 460-3588 Ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
(609) 460-3566 Ext. 1083