Zusduri (mitomycin intravesicular) / UroGen - LARVOL DELTA

Response to primary chemoablation with UGN-102 in different EOTRC risk groups. (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT05243550. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

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 | "Clinical Trial Registry Number: NCT05243550. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Bladder Cancer • Genito-urinary Cancer • 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

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

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 2025) - P3 | "The CRR and DoR were favorable in all subgroups and no significant differences were observed. Study limitations were the small sample size of comparator groups, single arm design, and post-hoc nature of the analysis. UGN-102 may represent a valuable treatment option for many patients with LG-IR-NMIBC."

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

Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial. (ASCO 2025) - P3 | "In the ENVISION study treatment with UGN-102 in patients with recurrent LG-IR-NMIBC resulted in a high and clinically meaningful CR rate. Patients who achieved an initial CR at 3 months had a high probability of remaining disease-free 18 months later. This data confirms that UGN-102 represents a valuable treatment option for patients with LG-IR-NMIBC."

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

Treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: Results of the phase 3 ATLAS and ENVISION studies. (ASCO 2025) - P3 | "In both studies, CR rate in patients initially treated with UGN-102 was robust, with the majority of patients remaining event free at 12 months follow-up. These results demonstrate that treatment with UGN-102 results in a high and clinically meaningful durable CR rate in patients with newly diagnosed or recurrent LG-IR-NMIBC. UGN-102 may represent a valuable nonsurgical treatment option for these patients."

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

FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (FDA) - "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)....Efficacy was evaluated in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with low-grade NMIBC that recurred after prior transurethral resection of bladder tumor (TURBT) and met 1-2 of the following criteria: multiple tumors, a solitary tumor >3 cm, and/or recurrence within 1 year....The major efficacy outcomes were complete response (CR) at 3 months and duration of response (DOR). CR was defined as no detectable disease in the bladder by cystoscopy and urine cytology....The recommended mitomycin dose is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter."

FDA approval • Bladder Cancer

UroGen Announces Data at ASCO 2025 Annual Meeting on UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) (Businesswire) - "UGN-102 data featured at ASCO: (i) Duration of Response (DOR) Following Treatment with UGN-102 in Patients with Recurrent, Low-Grade, Intermediate-Risk, Non-Muscle Invasive, Bladder Cancer: 18-Month DOR Data from the Phase 3 ENVISION Trial: Abstract #4598, Poster #398; (ii) 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: Abstract #4597, Poster #397; (iii) Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer with UGN-102: Results of the Phase 3 ATLAS and ENVISION Studies. Published Abstract 501822."

P3 data • Bladder Cancer

UroGen Pharma (URGN) Shares Plummet After FDA Advisory Vote (Gurufocus) - "UroGen Pharma (URGN, Financial) experienced a significant stock drop of approximately 47% following a setback with the U.S. Food and Drug Administration (FDA). The FDA's Oncology Drug Advisory Committee (ODAC) voted against the company's bladder cancer treatment, UGN-102 (mitomycin), with a close vote of 4 in favor and 5 against. This decision comes as UGN-102 undergoes regulatory review in the U.S. The rejection poses a substantial challenge for UroGen Pharma, which is seeking approval for UGN-102 to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)."

ODAC • Stock price • Bladder Cancer

FDA ODAC Votes 5-to-4 Against UGN-102 Intravesical Solution for Bladder Cancer (Cancer Network) - "Based on a vote of 5-to-4, the FDA Oncologic Drug Advisory Committee has voted against a benefit/risk ratio of UGN-102 (mitomycin) for patients with low-grade intermediate-risk non-muscle invasive bladder cancer....The decision comes based on results from the phase 3 ENVISION trial....a single-arm study assessing UGN-102 in patients in the aforementioned population....TEAEs leading to treatment discontinuation occurred in 2.9% of patients, and 2.5% had TEAEs leading to study discontinuation, but none of which were related to the study procedure....Of note, 3 patients died during the study from pneumonia, cardiac failure, or an unknown reason. None of which was related to treatment."

ODAC • Bladder Cancer