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Risk-Stratified NMIBC Management

Actionable Clinical Data
Videos
Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Mark Schoenberg, MD
The 2026 American Urological Association annual meeting featured a non-invasive bladder cancer session and a presentation by Dr. Mark Schoenberg discussing 24-month duration of response data from the phase 3 ENVISION trial assessing treatment with UGN-102 in patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer.
Presented by Ashish M. Kamat, MD, MBBS
The 2026 AUA annual meeting featured a non-muscle invasive bladder cancer session and a presentation by Dr. Ashish Kamat discussing the duration of response to UGN-102 by age at baseline across 3 clinical trials in patients with recurrent low-grade intermediate risk bladder cancer.
Presented by William Huang, MD
The 2026 SESAUA annual meeting featured a bladder cancer session and a presentation by Dr. William Huang discussing the response to treatment with UGN-102 in patients with early or late recurrent low-grade intermediate risk non-muscle invasive bladder cancer. Low-grade intermediate risk non-muscle invasive bladder cancer is a highly persistent and recurrent disease, where patients typically undergo treatment with repeated TURBTs under general anesthesia.
Presented by Trushar Patel, MD
The 2026 SESAUA annual meeting featured a bladder cancer session and presentation by Dr. Trushar Patel discussing patient-reported outcomes before and after treatment with UGN-102 in adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Low-grade intermediate risk non-muscle invasive bladder cancer is typically managed with TURBT conducted under general anesthesia; disease recurrence is common.
Presented by William Huang, MD
The 2026 SESAUA annual meeting featured a bladder cancer session and presentation by Dr. William Huang discussing long-term results from the single-arm, phase 2 OPTIMA II study assessing UGN-102 for low-grade intermediate risk non-muscle invasive bladder cancer.
Presented by William Huang, MD
The 2026 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. William Huang discussing response to primary chemoablation with UGN-102 in different EORTC risk groups. The ENVISION phase 3 study treated patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer with UGN-102, a reverse thermal hydrogel administered intravesically containing 75 mg mitomycin.
Presented by Dr. Xuebing Han
The 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA, between February 26th and 28th, 2026, was host to the Poster Session B: Prostate Cancer and Urothelial Carcinoma. Dr. Xuebing Han presented the poster: Efficacy and safety of disitamab vedotin combined with intravesical electromotive mitomycin-C in patients with HER-2 expressing high-risk nonmuscle invasive bladder cancer (NMIBC): A phase II study.
Presented by Ruchika Talwar, MD
The 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA, between February 26th and 28th, 2026, was host to the Poster Session B: Prostate Cancer and Urothelial Carcinoma. Dr. Ruchika Talwar presented the poster: Patient experiences with UGN-102 for recurrence of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC): Insights for shared decision making.
Presented by Karim Chamie, MD, MSHS
The 2025 Western Section AUA annual meeting featured a urothelial carcinoma session and a presentation by Dr. Karim Chamie discussing long-term outcomes of primary chemoablation of new-onset or recurrent low-grade upper tract urothelial carcinoma with UGN-101. Endoscopically guided ablation is commonly used to treat low-grade upper tract urothelial carcinoma. Surgical ablation is effective, but not typically durable, requiring long-term endoscopic surveillance associated with potential complications.
Presented by Jay D. Raman, MD,
The 2025 Western Section AUA annual meeting featured a urothelial carcinoma session and a presentation by Dr. Jay Raman discussing 5-year outcomes of the phase 2b Optima II study assessing the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102.
Presented by Chinedu Mmeje, MD
Chinedu Mmeje, MD, discusses the impact of tumor burden or focality on duration of response to treatment with UGN-102 in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer from the ENVISION phase 3 study.
Presented by Sandip M. Prasad, MD, MPhil
The 2025 ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing 18-month data from the phase 3 ENVISION trial assessing duration of response following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive bladder cancer.
Presented by John Sfakianos, MD
The 2025 ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. John Sfakianos discussing a substudy of the phase 3 ENVISION trial assessing the impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer on response to treatment with UGN-102.
Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced patient-reported outcomes following treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Presented by Sandip Prasad, MD, MPhil
The AUA 2025 Annual Meeting was host to a non-invasive bladder cancer podium session. Dr. Sandip Prasad presented the interim results of ENVISION, an ongoing single arm, open label, phase III trial evaluating UGN-102 for the treatment of recurrent, low-grade, intermediate-risk (LG-IR) NMIBC.
Presented by Neal D. Shore, MD, FACS
The American Urological Association's 2025 Annual Meeting was host to the Plenary Session: Paradigm-Shifting, Practice-Changing Clinical Trials in Urology. Dr. Neal Shore discussed how Sasanlimab in combination with BCG improves event-free survival versus Bacillus Calmette-Guerin as standard of care in high-risk non-muscle-invasive bladder cancer.
Presented by William C. Huang, MD
The 2025 SESAUA annual meeting featured a bladder cancer session and a presentation by Dr. William Huang discussing results from the ENVISION trial assessing primary chemoablation of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102. Low-grade, intermediate-risk, non-muscle invasive bladder cancer is a persistent and recurrent cancer that is inadequately controlled by the current standard of care, TURBT.
Presented by Sandip M. Prasad, MD
The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing a substudy of the phase 3 ENVISION trial assessing the impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer on response to treatment with UGN-102.
Presented by Sandip M. Prasad, MD

The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing results of the phase 3 ATLAS and ENVISION studies assessing treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer with UGN-102. Low grade intermediate risk non-muscle invasive bladder cancer is a persistent, recurrent cancer inadequately controlled by TURBT, which is the current standard of care.

Presented by Vincent Bivens, MD
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Vincent Bivens discussing home instillation of UGN-102 for primary chemoablation of recurrent low-grade intermediate risk non muscle invasive bladder cancer (NMIBC). Bladder cancer is the 6th most common cancer in the US, with approximately 83,000 incident cases annually, and at diagnosis, 75% of patients present with NMIBC.
Presented by Sandip M. Prasad, MD
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Sandip Prasad discussing the ENVISION trial assessing primary chemoablation of recurrent low-grade intermediate risk NMIBC with UGN-102. Low-grade, intermediate-risk NMIBC is a persistent and recurrent cancer that is inadequately controlled by the current standard of care, TURBT.
Presented by William Huang, MD
The 2024 American Urological Association (AUA) Annual Meeting held in San Antonio, TX 2024 was host to a non-invasive bladder cancer podium session. Dr. William Huang presented a post hoc analysis of the ATLAS trial evaluating the response to primary chemoablation with UGN-102 in patients with new or recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Presented by Sandip M. Prasad, MD
The 2023 Society of Urologic Oncology (SUO) annual meeting held in Washington, D.C. between November 28th and December 1st, 2023, was host to a poster/abstract session. Dr. Sandip Prasad presented the results of the recently published phase 3 ATLAS trial comparing primary chemoablation with UGN 102 ± TURBT versus TURBT monotherapy in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Presented by Christine E. Lentowski, MS, MBS
The 2022 Society of Urologic Oncology annual meeting featured a session on bladder cancer, including a presentation by Christine Lentowski discussing the trial design of a phase 3 single-arm study of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle invasive bladder cancer.
Presented by Angela B. Smith, MD, MS
The 2022 Southeastern Section of the AUA’s annual meeting included a bladder cancer session and Dr. Angela Smith discussing results of OPTIMA II, a phase 2b, open-label, single arm trial assessing primary chemoablation of low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC) using UGN-102. 
Presented by William Huang, MD
Most patients newly diagnosed with bladder cancer have non-muscle invasive disease (NMIBC). For patients with intermediate or high-risk NMIBC and those with carcinoma in situ (CIS), adjuvant treatment with BCG is guideline-recommended on the basis of proven benefits in disease recurrence.
Presented by William Huang, MD
 Low-grade intermediate-risk non-muscle-invasive bladder cancer can consist of multiple and/or recurrent low-grade Ta tumors. It has high rates of recurrence but a low risk of disease progression. Transurethral resection of bladder tumor (TURBT) plus intravesical therapy is considered the standard of care.
Publications
Peer-Reviewed Journal Abstracts

Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a chronic illness commonly treated by repetitive transurethral resection of bladder tumor (TURBT). We compared the efficacy and safety of intravesical chemoablation with UGN-102 (a reverse thermal gel containing mitomycin), with or without subsequent TURBT, to TURBT alone in patients with LG IR NMIBC.

The trial "OPTimized Instillation of Mitomycin for Bladder Cancer Treatment" (Optima II, clinicaltrials.gov: NCT03558503) was a Phase 2b trial evaluating a nonsurgical alternative as a primary treatment for non-muscle-invasive bladder cancer (NMIBC).

Low-grade intermediate-risk non-muscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumors (TURBT) under general anesthesia.

Physician-Scientist Commentaries
Peer-reviewed Abstract Supplemental Commentaries
Intravesical BCG has remained the cornerstone of treatment for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) for a near half century. However, its limitations are well recognised. Treatment-related toxicity, suboptimal completion rates, and ongoing global supply constraints all undermine its effectiveness in routine clinical practice.

Dr. Suzanne Merrill reviewed recent updates in immunotherapy for bladder cancer, noting a strong biologic rationale for its use given the disease’s capacity to evade immune detection and destruction. Bladder cancer can downregulate tumor antigen presentation and inactivate cytotoxic T-cells, thereby creating an immunosuppressive microenvironment:

Dr. Joshua Meeks discussed current and future approaches in muscle-invasive bladder cancer, highlighting three key phases in 2025—neoadjuvant, local, and adjuvant—which formed the framework for his talk.

Dr. Piyush Agarwal discussed current treatment options and future directions in non–muscle-invasive bladder cancer, noting that disease staging is based on depth of penetration, with NMIBC encompassing carcinoma in situ (CIS), Ta, and T1 disease.

The Phase 3 ATLAS trial of primary chemoablation using UGN-102, a reverse thermal gel containing mitomycin, provides important data about a potential nonsurgical alternative therapy for patients diagnosed with low grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). This form of urothelial malignancy affects over 80,000 Americans annually, recurs commonly, and is currently managed by repetitive transurethral resection of bladder tumor (TURBT).
Press Releases
Official Announcements on Clinical Developments
Reno, Nevada (UroToday.com) --  UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced robust preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
  • Reported three-month complete response rate of 77.8% from the Phase 3 UTOPIA trial of UGN-103, consistent with ENVISION results; FDA agreed to regulatory plan to submit an NDA based on data from the UTOPIA trial
  • ZUSDURI received unique J-Code (J9282) in October 2025, effective January 1, 2026
  • ZUSDURI achieved net product revenue of $1.8 million in Q3 2025; October 2025 preliminary demand revenue estimate of $4.5 million reflecting accelerating growth entering Q4 2025
  • JELMYTO® achieved net product revenue of $25.7 million in Q3 2025, representing YoY underlying demand revenue growth of 13%
  • $127.4 million in cash, cash equivalents and marketable securities as of September 30, 2025 
  • Conference call and webcast to be held today at 10:00 AM ET
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%)

Reno, Nevada (UroToday.com) -- 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 months from the Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution, a treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The median follow-up time after a three-month CR in this analysis was 23.7 months. The median DOR has not been reached.
Reno, Nevada (UroToday.com) -- On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Reno, Nevada (UroToday.com) -- UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC.
  • UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months
  • 79.6% complete response rate at 3 months in patients treated with UGN-102
  • Safety profile consistent with prior clinical trials of UGN-102
  • The Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3%
  • Patients Receiving UGN-102 had a 79.6% Complete Response Rate at Three Months
  • Side Effect Profile Consistent with Previous Clinical Trials of UGN-102
Reno, Nevada (UroToday.com) UroGen Pharma Ltd., a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced positive topline data from its Phase 3 trials ATLAS and ENVISION studying UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Both ATLAS and ENVISION trials met their primary endpoints.
Reno, Nevada (UroToday.com) UroGen Pharma Ltd. a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that The Journal of Urology published data from the Phase 3 ATLAS trial for investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), that demonstrated superiority to transurethral resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102.
-- Results from this ongoing, noninterventional rollover study were presented at the 23rd Annual Society of Urological Oncology (SUO) Meeting in San Diego

Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd., a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102
-- ENVISION Study Design Similar to Successful UGN-102 Phase 2b OPTIMA II Trial --

Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd., a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin) for intravesical solution, in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Study explores opportunity to shift from clinic to home instillation of this promising non-surgical treatment

Potential to transform care and access to treatment for this growing patient population

San Francisco, CA (UroToday.com) -- UroGen Pharma Ltd., a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, announced that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
  • Clinically Meaningful Response and Sustained Durability Underscore Potential for UGN-102 to Become a Non-Surgical Primary Therapeutic Treatment for Patients with Highly Recurrent LG IR-NMIBC
    • 65% Complete Response (CR) Rate at Three Months
    • 61% of Patients Remain in CR at 12 Months
  • Data Supports Ongoing Phase 3 Development of UGN-102 in LG IR-NMIBC as an Alternative to Surgery
  • 65% Complete Response in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
  • Patients who Achieved a Complete Response and Underwent an Evaluation at Each Timepoint, 97%, 86% and 85% Remained Disease Free at Six, Nine and 12 Months Following Initiation of Therapy, Respectively
  • Positive Data Continue to Validate UroGen’s Proprietary Technology Platform and Value of Intravesical Therapy Dwell Time
  • American Urological Association Abstract Presentations Available Online In Lieu of Annual Meeting
  • Complete Response (CR) Rate of 65% at Three Months
  • Of those with CR, 97% and 85% of Patients Remained Free of Disease at Six and Nine Months Follow-Up, Respectively
  • Detailed Results Presentation to be Shared Virtually via American Urological Association (AUA) in mid-May