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

Among 20 complete responders in extended follow-up, 75% remained event-free as of March 2025.

Rhea-AI Summary

UroGen Pharma (Nasdaq: URGN) announced publication of final Olympus five-year follow-up results evaluating JELMYTO response durability in adults with low-grade upper tract urothelial cancer.

Among 41 patients who achieved a complete response after initial treatment, median response duration was 47.8 months, with median follow-up of 28.1 months (95% confidence interval: 13.1–60.1). Twenty patients entered long-term follow-up, with median follow-up of 53.3 months (95% confidence interval: 27.9–72.8). In that group, median response duration could not be estimated because too few events occurred; its 95% confidence interval was 43.5 months to not estimable. As of March 2025, 75% (15/20) remained event-free, with no progression to high-grade disease observed. The results appeared in Therapeutic Advances in Urology.

Positive

• Minor pointMedian response duration reached 47.8 months among 41 complete responders, with median follow-up of 28.1 months.
• Minor pointEvent-free status persisted in 75% (15/20) of long-term follow-up patients as of March 2025.
• Minor pointProgression to high-grade disease was not observed during extended follow-up.
• Minor pointMedian response duration was not estimable due to the low event rate in the 20-patient long-term group.

Negative

• Minor pointLong-term follow-up findings cover 20 patients who achieved a complete response, rather than all treated patients.

Key Figures

Patients with complete response: 41 patients Median duration of response: 47.8 months Long-term follow-up cohort: 20 patients +2 more

Patients with complete response

41 patients

Olympus trial patients in the response-duration analysis

Median duration of response

47.8 months

Among 41 patients; median follow-up 28.1 months (95% CI: 13.1–60.1)

Long-term follow-up cohort

20 patients

Median follow-up 53.3 months (95% CI: 27.9–72.8)

Median duration of response

Not estimable

Long-term follow-up cohort; 95% CI: 43.5 to not estimable, due to low event rate

Event-free patients

75% (15/20)

Long-term follow-up study as of March 2025

Key Terms

complete response, chemoablation, 95% ci, pyelocalyceal solution

4 terms

complete response medical

"achieved a complete response following primary chemoablation with JELMYTO"

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

chemoablation medical

"following primary chemoablation with JELMYTO"

Local destruction of unwanted tissue—usually a tumor or lesion—by applying a chemical agent that kills cells or causes tissue necrosis. Chemoablation normally involves delivering a cytotoxic or sclerosing substance directly into or onto the target area (by injection, instillation, or catheter) so the effect is localized rather than systemic; it is distinct from surgical removal and from thermal or radiation ablation because the destructive agent is a chemical.

95% ci technical

"median follow-up of 28.1 months (95% CI: 13.1, 60.1)"

A 95% confidence interval is a range around a measured value that conveys how much uncertainty there is: if the same measurement or analysis were repeated many times, about 95% of those ranges would contain the true value. Think of it like the spread of where arrows land around a bullseye—narrower spread means more precision. Investors use it to judge how reliable an estimate or forecast is and to compare the risk of different outcomes.

pyelocalyceal solution medical

"JELMYTO® (mitomycin) for pyelocalyceal solution"

A liquid that occupies or is placed into the renal pelvis and calyces—the hollow collecting spaces inside a kidney. The term can mean the patient's own urine that fills those spaces or a fluid deliberately introduced during a medical procedure (for example saline, irrigation fluid or contrast agent) to enable imaging, drainage, sampling, or surgical work; when used about a procedure it denotes the fluid within that specific anatomical system, not fluid elsewhere in the urinary tract.

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• Five-year Olympus follow-up data published in Therapeutic Advances in Urology reinforce the long-term durability of response with JELMYTO
• Results demonstrate sustained disease control through extended follow-up among patients who achieved a complete response after treatment with JELMYTO
• No progression to high-grade disease was observed during extended follow-up
  
  

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:

• are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
• are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
• Tell your healthcare provider if you take water pills (diuretic).
  

How will I receive JELMYTO?

• Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
• You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
• JELMYTO is given to your kidney through a tube called a catheter.
• During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving JELMYTO:

• JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
• To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

JELMYTO may cause serious side effects, including:

• Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
• Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
• The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
  

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did UroGen's Olympus five-year follow-up show for JELMYTO?

As of March 2025, 75% (15/20) of patients in long-term follow-up remained event-free, and no progression to high-grade disease was observed. These patients had achieved a complete response after initial JELMYTO treatment; median follow-up in this group was 53.3 months.

How long did responses last in UroGen's Olympus JELMYTO study?

Median response duration was 47.8 months among all 41 patients who achieved a complete response after initial treatment. In the 20-patient long-term follow-up group, median response duration was not estimable because of the low event rate.