• EORTC Recurrence Score Analysis from the Pivotal ENVISION Trial to be Presented at the 2026 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO-GU 2026)

PRINCETON, N.J., Feb. 27, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative, non-surgical therapies for urothelial and specialty cancers, today announced new post-hoc analyses from the Phase 3 ENVISION trial showing that ZUSDURI™ (mitomycin) for intravesical solution (formerly known as UGN-102) achieved durable complete response (CR) rates across European Organization for Research and Treatment of Cancer (EORTC) recurrence score groups in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). A poster including the ENVISION trial EORTC recurrence score analysis will be presented at ASCO-GU 2026, which is being held February 26-28, 2026, in San Francisco, CA, and virtually.

CR rates at three months were 83.9%, 81.2%, and 60.0% in patients with low (1-4), intermediate (5-9), and high (10-17) EORTC recurrence scores, respectively, with the majority of responders across all groups remaining recurrence-free at 24 months.

“These results are particularly meaningful because they demonstrate that ZUSDURI can achieve robust complete response rates, even in patients with a higher baseline risk of recurrence,” said Sandip M. Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. “Importantly, the durability of response observed with ZUSDURI across EORTC risk categories highlights a meaningful advance for patients with recurrent LG-IR-NMIBC, a population with limited treatment options.”

The Phase 3 ENVISION (NCT05243550) trial evaluated ZUSDURI, a reverse thermal hydrogel administered intravesically containing 75 mg mitomycin, in patients with recurrent LG-IR-NMIBC. In the overall study population, ZUSDURI achieved a CR rate of 79.6% at three months (95% CI: 73.9–84.5), with a Kaplan-Meier probability of remaining event-free at 24 months of 72.2% (95% CI: 64.1–78.8).

In the post-hoc analysis of 240 treated patients stratified by EORTC recurrence score, high CR rates were observed across all risk groups at three months. CR rates were 83.9% (95% CI: 66.3–94.5) in patients with EORTC scores of 1–4, 81.2% (95% CI: 74.9–86.4) in patients with EORTC scores of 5–9, and 60.0% (95% CI: 32.2–83.7) in patients with EORTC scores of 10–17. Among patients achieving a CR, the majority remained recurrence-free at 24 months across all groups, with a Kaplan-Meier probability of remaining event-free of 67.4% (95% CI: 43.2–83.1), 73.7% (95% CI: 64.6–80.8), and 66.7% (95% CI: 28.2–87.8) for the EORTC score groups of 1–4, 5–9, and 10–17, respectively. Across the subgroups, Kaplan-Meier estimate of median duration of response was not reached, reflecting low recurrence event rates during follow-up.

“The consistency of response we’re seeing across EORTC recurrence score groups reinforces the therapeutic benefit of ZUSDURI,” said Mark Schoenberg, MD, Chief Medical Officer, UroGen. “These findings build on the strong primary results from ENVISION and further support ZUSDURI as a non-surgical treatment option designed to address the chronic and recurrent nature of this disease.”

Despite the post-hoc design and small sample sizes in some subgroups, the results suggest that ZUSDURI may provide durable and clinically meaningful benefit, regardless of baseline recurrence risk. Patients in ENVISION will continue to be followed for recurrence and progression for up to five years. The EORTC is an international academic research organization that conducts large multicenter clinical trials and develops widely validated prognostic and risk-stratification tools. Its bladder cancer recurrence score tables are commonly used to estimate recurrence risk based on established clinical and pathological factors.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel ® technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com .

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 is approved to treat low-grade upper tract urothelial cancer, and our second product, ZUSDURI (mitomycin) for intravesical solution, 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 ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.

Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems
  • are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.

Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.

Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose.

• are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.

How will I receive ZUSDURI?

  • You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
  • During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving ZUSDURI:

  • ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 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.

    The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.

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 ZUSDURI 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 potential benefits of ZUSDURI implied or suggested by the data, including its potential to provide durable and clinically meaningful benefit regardless of baseline recurrence risk; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs, other than mitomycin; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “can,” “estimate,” “expect,” “likely,” “may,” “potential,” “up to,” “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: clinical results may not be indicative of results that may be observed in the future, including in larger populations; potential safety and other complications related to UroGen’s products; risks related to UroGen’s and its licensors’ ability to protect their respective patents and other intellectual property; 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 ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025, 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
[email protected]
609-460-3588 ext. 1093

MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
[email protected]
609-460-3566 ext. 1083