On March 30, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the publication of results from the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution in The Journal of Urology. ZUSDURI is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached.

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"The publication of these long-term data in The Journal of Urology provides important peer-reviewed validation of the durability of ZUSDURI treatment observed in the ENVISION trial," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, New Jersey, and Principal Investigator of the ENVISION trial. "For patients who achieved a complete response, the likelihood of remaining event-free through two years was substantial, underscoring the potential of ZUSDURI to change the long-term management of this highly recurrent disease with a six-week induction treatment alone without maintenance. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy."

The existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates, patients, who are often elderly with multiple comorbidities, may require repeated TURBT procedures over their lifetime, which can negatively impact quality of life and may be associated with increased health risks. An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually in the United States.

"Now that the 24-month duration of response data from ENVISION are published in a leading urology journal, we’re seeing even stronger validation of ZUSDURI’s clinical impact," said Mark Schoenberg, Chief Medical Officer, UroGen. "As the first and only approved treatment for recurrent LG-IR-NMIBC, ZUSDURI gives patients a real chance at meaningful, recurrence-free periods. These results suggest we may finally be able to break the long-standing cycle of repeated recurrences and surgeries that has defined care for patients with recurrent LG-IR-NMIBC."

The most common (≥10%) adverse reactions, including laboratory abnormalities, observed in patients treated with ZUSDURI were dysuria, hematuria, urinary tract infection, increased creatinine, increased potassium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, increased eosinophils, and increased liver enzymes (AST and ALT). Adverse reactions were primarily mild to moderate in severity. Serious adverse reactions occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

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.

(Press release, UroGen Pharma, MAR 30, 2026, View Source [SID1234664030])