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 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

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

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

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

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

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

Safety Profile of UGN-102 in the Treatment of Adult Patients with Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (MA-AUA 2026) - No abstract available

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

UTOPIA: A phase 3 trial of UGN-103, an intravesical mitomycin reverse thermal hydrogel, in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. (ASCO 2026) - P3 | "UGN-103 demonstrated a safety and efficacy profile similar to that observed with UGN-102 in patients with recurrent LG-IR-NMIBC, supporting continued evaluation of UGN-103 as an intravesical treatment option."

P3 data • Atrial Fibrillation • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Osteoarthritis • Respiratory Diseases • 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

Advances in intravesical therapy for non-muscle-invasive bladder cancer (PubMed, Zhong Nan Da Xue Xue Bao Yi Xue Ban) - "With regard to targeted therapy, erdafitinib has achieved breakthrough progress in patients with BCa harboring fibroblast growth factor receptor (FGFR) mutations or fusions. Novel drug delivery systems, such as the mitomycin-containing hydrogel formulation UGN-102, has been approved for marketing by the U.S. Food and Drug Administration (FDA). In addition, gene therapies such as nadofaragene firadenovec have entered clinical practice, while novel treatment modalities, including viral therapies, have progressed to the clinical trial stage. An in-depth understanding of the latest advances in intravesical therapy for NMIBC may provide evidence-based support for clinical decision-making and inform future combination and individualized treatment strategies."

IO biomarker • Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

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

ZUSDURI (mitomycin) for intravesical solution (The Manila Times) - "ZUSDURI achieved net product revenue of $50.4 million in the second quarter of 2026, representing 73% growth over the first quarter of 2026. As of June 30, 2026, UroGen reported: 1,444 activated sites of care; 452 unique ZUSDURI prescribers; 204 repeat ZUSDURI prescribers, representing approximately 45% of total prescribers, up from 40% in the first quarter of 2026."

Commercial • Sales • Bladder Cancer

UroGen Receives New U.S. Patent Allowance Expected to Provide Protection into July 2044 for ZUSDURI and UGN-103 (GlobeNewswire) - "The allowed claims cover methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) without a transurethral resection of a bladder tumor (TURBT), supported by data from the ENVISION and ATLAS clinical trials. The U.S. patent, once issued, will have an expiration date in July 2044."

Patent • Bladder Cancer

Emerging Intravesical Therapies for Non-Muscle-Invasive Bladder Cancer. (PubMed, Urol Clin North Am) - "Recent advances include UGN-102 for low-grade/intermediate-risk disease and multiple FDA-approved agents-nadofaragene firadenovec, TAR-200, and nogapendekin alfa inbakicept-for BCG-unresponsive disease. Ongoing trials of TAR-210, cretostimogene, and other combination regimens promise to further expand options. Comparative studies and real-world evidence will be critical to define optimal sequencing, benchmark outcomes against radical cystectomy, and address quality-of-life considerations."

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

Assessing responses to UGN-102 across EORTC recurrence score groups in patients with recurrent low-grade intermediate-risk NMIBC (ENVISION trial). (ASCO 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."

Clinical • Bladder Cancer

Reply: UGN-102 for Recurrent Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer: A 24-Month Duration of Response Results from the Phase 3 ENVISION Trial. (PubMed, J Urol) - No abstract available

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

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) - P3 | "UGN-102 treatment in patients with recurrent LG-IR-NMIBC resulted in a clinically meaningful CR rate. Patients who achieved an initial CR at 3 months had a high probability of remaining event-free 12 and 24 months later. These data indicate that UGN-102 provides a durable event-free outcome for patients with recurrent LG-IR-NMIBC."

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

Patient Experiences and Preferences for Chemoablation and Intravesical Drug-Releasing Systems in Non-Muscle-Invasive Bladder Cancer — A Mixed-Methods Study (AUA 2026) - "Quantitative surveys assessed demographics, treatment history, and preferences among repeat TURBT, chemoablation (UGN-102), and an intravesical drug-releasing system (TAR-200). While most patients reported positive TURBT experiences, nearly half would have considered a clinical trial. Patients expressed interest in novel delivery systems for chemoablation, but only half preferred this approach over TURBT when efficacy was equal, underscoring that outcome efficacy outweighs procedural burden."

Clinical • 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) - P2b, P3 | "UGN-102 demonstrated robust CR rates across all age groups. Most patients remained event-free 12 months after CR in pooled data, and 24 months after CR in ENVISION. These findings support UGN-102 as an effective, durable, and age-independent treatment option for recurrent LG-IR-NMIBC."

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

UroGen reports 64.5% event-free rate at three years for bladder cancer drug (Investing.com) - “UroGen Pharma Ltd announced…patients who achieved complete response with ZUSDURI maintained a 64.5% event-free rate at three years in the Phase 3 ENVISION trial…The Kaplan-Meier analysis showed that 79.6% of patients achieved complete response at three months. Among these responders, 64.5% remained disease-free at 36 months without maintenance therapy. At a median follow-up of 35.5 months, the median duration of response had not been reached.”

P3 data • Bladder Cancer

Q1 2026 and Recent Business Highlights (GlobeNewswire) - "ZUSDURI achieved net product revenue of $29.2 million in the first quarter of 2026, representing 109% quarter-over-quarter growth. The accelerating growth trend in prescribers, particularly repeat prescribers, reflects increasing health care provider confidence and successful integration of ZUSDURI into routine urology practice. As of March 31, 2026, UroGen reported: 972 activated sites of care; 256 unique ZUSDURI prescribers; 103 repeat ZUSDURI prescribers...JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC: Generated net product revenue of $21.7 million in the quarter ended March 31, 2026, an increase of approximately 7% over the $20.3 million reported for first quarter of 2025."

Sales • Bladder Cancer • Urothelial 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

UGN-102 for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial. (PubMed, J Urol) - P3 | "These data indicate UGN-102 is a novel, nonsurgical treatment that provides a durable CR for patients with recurrent LG-IR-NMIBC. Study limitations included the single-arm design and the limited racial diversity of the patients."

Journal • P3 data • 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

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