Core Insights - UroGen Pharma Ltd. has received a permanent J Code (J9282) from the Centers for Medicare and Medicaid Services (CMS) for ZUSDURI (mitomycin), the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2] - The J Code will be effective from January 1, 2026, and aims to streamline billing and claims submission for healthcare providers [1][2] - ZUSDURI utilizes UroGen's proprietary RTGel® technology, allowing for non-surgical treatment of bladder tumors through a sustained release, hydrogel-based formulation [3][5] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, with a commitment to improving treatment options for patients [5] - The company has developed RTGel technology, which enhances the therapeutic profiles of existing drugs by enabling longer exposure of urinary tract tissue to medications [5] - UroGen's product portfolio includes ZUSDURI for recurrent LG-IR-NMIBC and a previously approved product for low-grade upper tract urothelial cancer [5] Market Context - Approximately 82,000 individuals in the U.S. are diagnosed with NMIBC annually, with around 59,000 cases being recurrent [4] - The median age of diagnosis for bladder cancer is 73 years, and up to 70% of NMIBC patients experience at least one recurrence [4]

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]

Core Insights - UroGen Pharma has achieved a significant milestone with the FDA approval of ZUSDURI for treating adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), marking its transition into a multi-product uro-oncology company [2][7] - The company is targeting a market opportunity exceeding $5 billion and is actively executing the launch plan for ZUSDURI while continuing to grow its existing product, JELMYTO [2][6] - UroGen's financial results for Q2 2025 show a net product revenue of $24.2 million for JELMYTO, reflecting an 11% year-over-year growth driven by underlying demand and price favorability [6][10] Financial Performance - JELMYTO net product revenues for Q2 2025 were $24.2 million, up from $21.8 million in Q2 2024, indicating an 11% increase [10] - Research and Development (R&D) expenses for Q2 2025 were $18.9 million, an increase from $15.4 million in Q2 2024, primarily due to higher manufacturing costs and expenses related to the Phase 3 UTOPIA trial [11] - Selling, General and Administrative (SG&A) expenses rose to $43.2 million in Q2 2025 from $30.1 million in Q2 2024, driven by commercial preparation activities for ZUSDURI [12] - The company reported a net loss of $49.9 million in Q2 2025, compared to a net loss of $33.4 million in the same period in 2024 [15][20] Product Development and Pipeline - Enrollment is complete for the Phase 3 UTOPIA trial of UGN-103, a next-generation mitomycin formulation aimed at improving treatment for recurrent LG-IR-NMIBC [5][8] - UroGen is also advancing its immuno-oncology candidates, with ongoing studies for UGN-301, an anti-CTLA4 antibody for high-grade non-muscle invasive bladder cancer [9] - The company is collecting real-world data through the uTRACT Registry to evaluate JELMYTO's use and outcomes in adult patients with upper tract urothelial carcinoma [7] Market Outlook - UroGen maintains its guidance for full-year 2025 net product revenues for JELMYTO in the range of $94 to $98 million, reflecting an expected growth rate of approximately 8% to 12% over 2024 [16] - The company is well-positioned to support the launch of ZUSDURI and advance its strategic initiatives for sustained growth and innovation [2][6]

Core Insights - UroGen Pharma announced a 24-month Duration of Response (DOR) of 72.2% for ZUSDURI in patients who achieved a complete response at three months from the Phase 3 ENVISION trial, indicating sustained efficacy for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [1][2][3] Company Overview - UroGen Pharma is focused on developing innovative solutions for urothelial and specialty cancers, with ZUSDURI being a significant product for treating recurrent LG-IR-NMIBC [7] - The company utilizes proprietary RTGel technology, which allows for sustained release of medication directly into the bladder, providing a non-surgical treatment option [4][7] Product Details - ZUSDURI (mitomycin) is an FDA-approved intravesical solution for adults with recurrent LG-IR-NMIBC, marking a transformative step in managing this chronic cancer [2][3][8] - The treatment is administered in an outpatient setting, which can improve patient quality of life compared to traditional surgical options [2][4] Clinical Trial Insights - The Phase 3 ENVISION trial involved 240 patients and evaluated the efficacy and safety of ZUSDURI, with a primary endpoint of complete response rate at three months [6] - The trial demonstrated that the event rate remained stable over time for patients who achieved a complete response, reinforcing the therapy's potential as a durable treatment option [2][3] Market Context - LG-IR-NMIBC affects approximately 82,000 individuals annually in the U.S., with around 59,000 experiencing recurrence, highlighting the need for effective treatment options [5] - The existing standard of care involves repeated surgical procedures, which can negatively impact patients' health and quality of life [2][5]

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]