On May 15, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, reported UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial of UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR observed with ZUSDURI (mitomycin) for intravesical therapy in its pivotal ENVISION trial. ZUSDURI is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for adult patients with recurrent LG-IR-NMIBC.
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Based on the consistency of UTOPIA data with the results of the ENVISION trial studying ZUSDURI in patients meeting the same eligibility criteria and alignment with the FDA, UroGen remains on track to submit a New Drug Application (NDA) for UGN-103 in the third quarter of 2026.
"The durability of response observed at six months with UGN-103 in the UTOPIA trial is generally consistent with that observed in the pivotal ENVISION trial of ZUSDURI, and highlights the potential to further advance care for adult patients with recurrent LG-IR-NMIBC," said Abishek Srivastava, MD, Urologic Oncologist at Atlantic Urology Clinics, Myrtle Beach, SC, START Center for Cancer Research, Carolinas and lead investigator of the UTOPIA trial. "UGN-103 builds on a proven therapeutic approach with meaningful innovations that could help enhance how we deliver this therapy in clinical practice."
UGN-103 is designed to build on the clinical and commercial foundation of ZUSDURI. The benefits of UGN-103 include a more streamlined manufacturing process and simplified reconstitution, while preserving the innovative and proven RTGel technology that enables sustained drug exposure at tumor sites in the bladder.
"These clinical data reinforce the potential of UGN-103 to become a new standard of care for adult patients with recurrent LG-IR-NMIBC," said Liz Barrett, President and Chief Executive Officer of UroGen. "With FDA alignment on our regulatory path, we are advancing with urgency toward NDA submission. We believe UGN-103 represents a significant opportunity to build on our leadership in uro-oncology, expand our commercial portfolio, and drive long-term growth."
UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.
About UTOPIA
The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation in an outpatient setting once weekly for six weeks. The primary endpoint is CR rate at three months, with responders entering a follow-up phase of up to 12 months to assess DOR. For more information on the UTOPIA study, please visit View Source
About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and extend the clinical and commercial profile of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property protection expected to extend into December 2041.
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 United States 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 NMIBC at www.BladderCancerAnswers.com.
(Press release, UroGen Pharma, MAY 15, 2026, View Source [SID1234665781])