Zusduri (mitomycin intravesicular) / UroGen - LARVOL DELTA

Patient experiences with UGN-102 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC): Insights for shared decision making. (ASCO-GU 2026) - P3 | "UGN-102 maintained stable quality-of-life scores across NMIBC24 domains and was generally preferred by patients over surgical resections. These important insights support shared decision making, enabling clinicians to discuss trade-offs between procedural convenience and treatment invasiveness in recurrent LG-IR-NMIBC management. SD, standard deviation."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Response to primary chemoablation with UGN-102 in different EOTRC risk groups. (ASCO-GU 2026) - P3 | "UGN-102 demonstrated robust complete response rates across all EORTC recurrence score subgroups, including patients with higher baseline recurrence risk. The majority of patients remained recurrence-free at 24 months. Despite the post-hoc design and small subgroup sizes, these findings suggest UGN-102 provides durable and clinically meaningful disease control in recurrent LG-IR-NMIBC."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SES AUA 2026: Response to Treatment with UGN-102 in Patients with Early or Late Recurrent Low-Grade Intermediate Risk NMIBC (UroToday) - "Complete response at 3 months was achieved by 96/124 patients (77.4%, 95% CI 69.0, 84.4) in the early group and 95/116 patients in the late group (81.9%, 95% CI 73.7, 88.4). The probability of remaining in response 12 and 24 months after complete response was similar for both groups (12 months - early: 82.5% versus late: 82.2%; 24 months - 70.3% early versus late: 72.5%)....There were 23 patients (24%) in the early and 25 (26.3%) in the late recurrence group that experienced an event (disease recurrence, progression, or death) post complete response, with most patients (early: n = 15; late: n = 21) experiencing low-grade disease recurrence."

P3 data • Bladder Cancer

Advances in Intravesical Therapy for Non-Muscle-Invasive Bladder Cancer. (PubMed, Crit Rev Oncol Hematol) - "Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise...Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients...Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

Treatment with UGN-102 in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer: 24-month duration of response data from the phase 3 ENVISION trial (AUA 2026) - No abstract available

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Duration of response to UGN-102 by age at baseline across 3 clinical trials in patients with low-grade intermediate-risk bladder cancer (AUA 2026) - No abstract available

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

UroGen Pharma…announced the grants of inducement restricted stock units ('RSUs') to 11 new employees in connection with their employment with UroGen (GlobeNewswire) - "These new team members will support the ongoing commercialization of JELMYTO (mitomycin) for pyelocalyceal solution and ZUSDUR (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline."

Commercial • Bladder Cancer • Urothelial Cancer

Q4 2025 and Recent Business Highlights (GlobeNewswire) - "ZUSDURI achieved net product sales of $15.8 million in 2025. As of December 31, 2025, UroGen reports: 838 activated sites of care; 102 unique ZUSDURI prescribers; 32 repeat ZUSDURI prescribers."

Sales • Bladder Cancer

ZUSDURI Achieves Durable Complete Responses Across EORTC Risk Groups in Patients with Recurrent LG-IR-NMIBC (GlobeNewswire) - "A poster including the ENVISION trial EORTC recurrence score analysis will be presented at ASCO-GU 2026....In the overall study population, ZUSDURI achieved a CR rate of 79.6% at three months (95% CI: 73.9–84.5), with a Kaplan-Meier probability of remaining event-free at 24 months of 72.2% (95% CI: 64.1–78.8). In the post-hoc analysis of 240 treated patients stratified by EORTC recurrence score, high CR rates were observed across all risk groups at three months. CR rates were 83.9% (95% CI: 66.3–94.5) in patients with EORTC scores of 1–4, 81.2% (95% CI: 74.9–86.4) in patients with EORTC scores of 5–9, and 60.0% (95% CI: 32.2–83.7) in patients with EORTC scores of 10–17."

P3 data • Bladder Cancer

Chemoablation with UGN-102 in intermediate-risk non-muscle invasive bladder cancer, are we there yet? (PubMed, Transl Androl Urol) - No abstract available

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer on response to treatment with UGN-102: A substudy of the phase 3 ENVISION trial. (ASCO-GU 2025) - P3 | "Although a non-significant higher event rate was observed at 3 months for patients with a higher tumor burden, the CRR was robust, and the majority of patients remained event free at 15 months. These results demonstrate that chemoablation using UGN-102 results in a high, clinically meaningful CRR in patients with recurrent LG-IR-NMIBC, regardless of tumor burden or multifocality. Study limitations were the small sample size of the comparator groups, single arm design, and post-hoc nature of the analysis."

P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: ongoing results from a single-arm, open-label, phase 3 trial (ENVISION) (AUA 2025) - P3 | "Results from ENVISION demonstrate that treatment with UGN-102 results in a robust CR rate in patients with recurrent LG-IR-NMIBC. Furthermore, trial participants who achieved an initial CR had a high probability of remaining disease-free 12 months later. UGN-102 may represent a well-tolerated, valuable alternative to TURBT for patients with LG-IR-NMIBC."

Clinical • P3 data • Bladder Cancer • Fatigue • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 ± Transurethral Resection of Bladder Tumor (TURBT) Compared to TURBT Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS). (PubMed, J Urol) - "Primary, non-surgical chemoablation with UGN-102 for the management of LG IR NMIBC offers a potential therapeutic alternative to immediate TURBT monotherapy and warrants further investigation."

Journal • Monotherapy • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION). (PubMed, J Urol) - P3 | "Limitations of this study included lack of tumor sizing after the diagnostic biopsy. ClinicalTrials.gov Identifier: NCT05243550."

Journal • P3 data • Bladder Cancer • Fatigue • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=99 | Active, not recruiting | Sponsor: UroGen Pharma Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Permanent J Code for ZUSDURI Now in Effect, Expanding Patient Access to Innovative Bladder Cancer Therapy (UroGen) - "The new code, J9282, assigned by the Centers for Medicare & Medicaid Services, is expected to streamline billing and reimbursement processes across hospital outpatient and physician office settings, reducing administrative delays that often stand between patients and timely treatment....As of January 1, 2026, physicians and treatment centers can utilize J9282 for ZUSDURI when submitting claims for eligible Medicare patients, subject to individual payer coverage policies."

Reimbursement • Bladder Cancer

Patient-reported outcomes following UGN-102 treatment in low-grade intermediate-risk non-muscle invasive bladder cancer: An analysis of three clinical trials. (PubMed, Urol Pract) - "Urinary TEAE occurrence during UGN-102 treatment was associated with transient worsening in mean QLQ-NMIBC24 urinary symptom scores that resolved by the 3-month visit. In these analyses, patients with LG-IR-NMIBC receiving UGN-102 did not report worsening QoL, functioning, or symptom burden, supporting its use as a nonsurgical treatment for LG-IR-NMIBC."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Q3 2025 and Recent BusinessHighlights: ZUSDURI(mitomycin) for intravesical solution (The Manila Times) - "ZUSDURI was assigned a unique, permanent Healthcare Common Procedure Coding System J-code (J9282) by the Centers for Medicare & Medicaid Services. The J-code is expected to be 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 demonstrates accelerating commercial uptake and growing physician adoption."

Reimbursement • Sales • Bladder Cancer

The ATLAS trial was a prospective, phase III, randomized, open-label trial that randomized patients with low-grade intermediate risk non-muscle invasive bladder cancer 1:1 to either UGN-102 +/- TURBT or TURBT alone (no adjuvant therapy). (UroToday) - "A 3-month complete response was observed in 65% (95% CI: 56–73%) of patients in the UGN-102 +/- TURBT arm, and 64% (95% CI: 55–72%) in the TURBT alone arm. Disease progression at the 3-month assessment was noted in 12 UGN-102 patients and 9 TURBT patients. Disease-free survival 15 months after randomization was estimated to be 72% for patients in the UGN-102 ± TURBT arm and 50% for patients in the TURBT monotherapy arm, with a hazard ratio of 0.45"

P3 data • Urothelial Cancer

Pharmacokinetics of UGN‑102, an investigational mitomycin‑containing reverse thermal gel for the treatment of non-muscle invasive bladder cancer. (PubMed, Cancer Chemother Pharmacol) - P2, P2b | "Intravesical instillation of UGN-102 results in low-level systemic absorption of mitomycin, with Cmax values considerably lower than those following IV administration and those associated with myelosuppression."

Journal • PK/PD data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

UroGen Pharma Expands Commercial Portfolio with Launch of ZUSDURI... (GlobeNewswire) - "ZUSDURI (mitomycin) for intravesical solution now available as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)."

Launch US • Bladder Cancer

UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (GlobeNewswire) - P3 | N=240 | ENVISION (NCT05243550) | Sponsor: UroGen Pharma Ltd. | "UroGen Pharma Ltd...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....ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%)."

P3 data • Bladder Cancer

Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-Year Long-Term Extension Study of the Single-Arm, Phase 2b Optima II Study. (PubMed, Clin Genitourin Cancer) - P2b | "For the 17 patients in the LTFU study the median DoR was 42.1 months (95% CI, 24.18-not estimable [NE]), with a median follow-up of 50.40 months (95% CI, 26.97-NE), These results demonstrate that treatment with UGN-102 results in clinically meaningful, and highly durable response in patients with LG-IR-NMIBC. UGN-102 may offer a promising non-surgical alternative to transurethral resection of bladder cancer (TURBT) for LG-IR-NMIBC patients."

Journal • P2b data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Novel intravesical delivery systems for nonmuscle invasive bladder cancer. (PubMed, Curr Opin Urol) - "Novel intravesical delivery systems show to enhance drug retention, improve tissue penetration, and potentially reduce adverse events. While traditional chemotherapy or BCG remain the gold-standard adjuvant treatments for NMIBC, these novel approaches offer promising alternatives for selected patients pending on ongoing clinical validation."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (GlobeNewswire) - P2b | N=63 | OPTIMA II (NCT03558503) | Sponsor: UroGen Pharma Ltd. | "UroGen Pharma Ltd...announced the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) demonstrating durable, long-term complete responses (CRs) in patients who initially achieved a CR following treatment with ZUSDURI....For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response (DOR) was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate (95% CI: 24.2, NE), with a median follow-up of 50.4 months."

P2b data • Bladder Cancer • Urothelial Cancer