On October 19, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-103 (mitomycin) for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.

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"FDA acceptance of the UGN-103 NDA advances our vision for the next evolution of our portfolio and our continued commitment to transforming the treatment of recurrent LG-IR-NMIBC," said Liz Barrett, President and CEO, UroGen. "Building on our experience with ZUSDURI (mitomycin) for intravesical solution, UGN-103 combines our proprietary RTGel technology with a novel mitomycin formulation, which leverages a streamlined manufacturing process and simplified reconstitution. We look forward to working closely with the FDA during its review and remain focused on delivering innovative treatment options for people living with this highly recurrent disease."

The NDA for UGN-103 is supported by the clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. Treatment with UGN-103 resulted in a 77.8% complete response (CR) rate at three months, and among patients who achieved a CR at three months, the Kaplan-Meier estimated probability of remaining event-free at six months was 94.5%. The three-month CR rate, the six-month duration of response (DOR), and the safety results observed in UTOPIA were consistent with those observed in the pivotal ENVISION trial of ZUSDURI. We are pleased to advance UGN-103 into FDA review as we continue to evaluate its potential role in the treatment of adults with recurrent LG-IR-NMIBC.

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 build on the clinical and commercial foundation 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 coverage expected to extend into July 2044.

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 people experiencing recurrence. 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.

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

(Press release, UroGen Pharma, OCT 19, 2026, View Source [SID1234673572])