Core Insights - UroGen Pharma Ltd. announced the publication of a comprehensive review of ZUSDURI™ (mitomycin) for intravesical solution, the first FDA-approved treatment for adults with recurrent, low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) [1][2] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained release of medications [11] - The company is headquartered in Princeton, NJ, with operations in Israel [11] Product Information - ZUSDURI is a non-surgical treatment option that has shown robust and durable complete response rates in clinical trials for recurrent LG-IR-NMIBC [2][3] - The drug is administered in an outpatient setting without the need for general anesthesia, making it a convenient option for patients [2] Clinical Development - The clinical development program for ZUSDURI includes three late-phase trials: OPTIMA II, ATLAS, and ENVISION, which evaluated its safety and efficacy [3][6] - The ENVISION trial enrolled 240 patients and assessed the complete response rate at three months post-treatment [8] Efficacy and Safety - Complete response rates in late-stage trials ranged from 64.8% to 79.6% at three months, with 80.6% of patients remaining disease-free at 18 months following complete response [6] - Adverse events were primarily localized to the lower urinary tract, with serious adverse reactions occurring in 12% of patients [6] Patient Demographics - Patients in the ZUSDURI clinical trials were predominantly elderly, with median ages between 67 and 70 years, and a significant proportion had multiple tumors and larger tumor sizes [4] Market Context - LG-IR-NMIBC affects approximately 82,000 individuals annually in the U.S., with around 59,000 being recurrent cases [7] - The standard care for NMIBC typically involves transurethral resection of bladder tumor (TURBT), but many patients experience recurrences [7]

PRINCETON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the second quarter ended June 30, 2025, and provided an overview of recent developments. "The recent FDA approval of ZUSDURI for the treatment of adults with recurrent LG-IR-NMIBC represents a truly transformative milestone for patients and for UroGen, marking ...

About ZUSDURI 24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the 24-month DOR of 72.2% (95% CI 64.1%, 78.8%) by Kaplan-Meier estimate in patients who achieved CR at three m ...

Core Insights - UroGen Pharma Ltd. announced positive results from a Phase 3b study on the home administration of ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2] - The study demonstrated that trained home health professionals can safely administer ZUSDURI outside traditional clinical settings, potentially easing patient burden and reducing reliance on hospital resources [2][3] Study Findings - The study involved eight patients, with 75% completing all six scheduled treatments; 75% of patients reported a complete response rate at three months [2][4] - Patients expressed high satisfaction with the home-based treatment, with five out of six recommending it to others [2] - No new safety concerns were identified, and the safety profile was consistent with previous studies, primarily involving mild-to-moderate urinary symptoms [3][4] Treatment Administration - ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose given in a clinic and subsequent doses at home [3] - Investigators found no significant differences in safety or efficacy between home and office administration [3] Company Overview - UroGen Pharma is focused on developing innovative treatments for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [5][8] - ZUSDURI is specifically approved for treating adults with recurrent LG-IR-NMIBC after unsuccessful bladder surgery [9] Market Context - Approximately 82,000 people in the U.S. are diagnosed with NMIBC annually, with around 59,000 experiencing recurrence [6] - The median age of diagnosis for bladder cancer is 73 years, highlighting the need for convenient treatment options for older patients [6]

Core Insights - UroGen Pharma Ltd. announced the publication of a five-year long-term extension study of the Phase 2b OPTIMA II trial, demonstrating durable long-term complete responses in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) treated with ZUSDURI (mitomycin) [1][2] Company Overview - UroGen Pharma is a biotech company focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [10] - ZUSDURI is specifically indicated for the treatment of adults with recurrent LG-IR-NMIBC, providing a non-surgical treatment option [5][11] Clinical Study Findings - The OPTIMA II trial included both newly diagnosed and recurrent adult patients with LG-IR-NMIBC, with 41 patients achieving complete response (CR) at three months post-treatment; 25 remained in CR at 12 months [2][4] - Among the 17 patients who entered the long-term follow-up study, the median duration of response (DOR) was 42.1 months, indicating ZUSDURI's potential for meaningful, lasting event-free periods [2][7] - The median Kaplan-Meier estimate of DOR for all 41 patients was 24.2 months, with a median follow-up of 35.8 months [2] Patient Demographics - The study cohort consisted of 17 patients, of which 16 (94%) were recurrent cases, highlighting the drug's relevance for patients facing repeated surgeries [4] Treatment Efficacy - ZUSDURI's long-term data emphasizes its ability to deliver sustained responses in an outpatient setting, which is particularly valuable for recurrent patients [2][3] - The study results reflect a commitment to providing innovative treatments that empower patients and physicians with more options [3] Safety Profile - Safety data were not collected during the long-term follow-up trial; however, the most commonly reported treatment-emergent adverse events in the parent OPTIMA II study included dysuria (41%), pollakiuria (21%), and hematuria (16%) [3][4]