Jelmyto (mitomycin urothelial gel) / UroGen - LARVOL DELTA

Kidney-Sparing Approaches in Upper Tract Urothelial Cancer: A Narrative Review. (PubMed, Cureus) - "Novel kidney-sparing therapies such as intraluminal chemoablation with UGN-101 and vascular-targeted photodynamic therapy show encouraging efficacy and safety in early trials...Despite these advances, long-term oncologic outcomes, optimal adjuvant regimens, and molecularly guided treatment algorithms remain incompletely defined. In order to verify oncologic efficacy, systematise follow-up protocols, and establish personalized therapeutic pathways guided by molecular patterns, future multicenter prospective studies are essential."

IO biomarker • Journal • Review • Genito-urinary Cancer • Nephrology • Oncology • Renal Disease • Solid Tumor • Urothelial 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

Phase II Trial of Lung Chemoemobolization (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Oct 2026 ➔ Oct 2027 | Trial primary completion date: Oct 2026 ➔ Oct 2027

Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

Generated net product sales of $94.0 million in the year ended December 31, 2025, compared to $90.4 million reported in 2024 (which included CREATES Act sales of $0.2 million in 2025 and $3.0 million in 2024). Underlying demand revenue grew by 7% year-over-year. (GlobeNewswire)

Sales • Urothelial Cancer

UT002: A Phase 3 Single-arm Study of UGN-104 for the Treatment of LG-UTUC (clinicaltrialsregister.eu) - P2/3 | N=59 | Recruiting | Sponsor: Urogen Pharma Ltd.

New P2/3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2029 ➔ Sep 2031 | Trial primary completion date: Sep 2029 ➔ Sep 2031

Trial completion date • Trial primary completion date • Anal Carcinoma • Colorectal Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Rectal Cancer • Solid Tumor • Squamous Cell Carcinoma • CD4 • IFNG

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study (clinicaltrials.gov) - P3 | N=486 | Recruiting | Sponsor: NRG Oncology | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2025 ➔ May 2026

Enrollment open • Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

The uTRACT registry: A single-arm, multicenter, prospective, and retrospective registry study to evaluate the real-world use of UGN-101 in participants with upper tract urothelial carcinoma (UTUC) in the United States. (ASCO 2025) - P | "J Urol. 2024:101097ju0000000000004331."

Real-world • Real-world evidence • Retrospective data • Oncology • Solid Tumor • Urothelial Cancer

Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial (clinicaltrials.gov) - P3 | N=129 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P3 trial • Appendix Cancer • Colorectal Cancer • Oncology • Solid Tumor

A Systematic Review of Intracavitary Therapies for Upper Tract Urothelial Carcinoma. (PubMed, Eur Urol Oncol) - "Intracavitary therapy for UTUC in the form of BCG for CIS and mitomycin C for papillary disease shows considerable efficacy, with acceptable safety profiles. These therapies represent a renal-preserving alternative for patients unfit for surgery or at high risk of renal failure, and the evidence supports their use in carefully selected patients."

Journal • Oncology • Pain • Renal Disease • Solid Tumor • Urothelial Cancer

SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Rutgers, The State University of New Jersey | Initiation date: Aug 2025 ➔ Jun 2026

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer (clinicaltrials.gov) - P1 | N=49 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Aug 2026 ➔ Jan 2028 | Trial primary completion date: Aug 2026 ➔ Jan 2028

Trial completion date • Trial primary completion date • Appendix Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Uterine Cancer

JELMYTO achieved net product revenue of $25.7 million in Q3 2025, representing YoY underlying demand revenue growth of 13% (The Manila Times)

Sales • Bladder Cancer • Urothelial Cancer

JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC (GlobeNewswire) - "Generated net product revenue of $24.2 million in the quarter ended June 30, 2025, an increase of 11% compared to the same quarter in 2024, driven by underlying demand growth of 7% and year-over-year price favorability."

Sales • Urothelial Cancer

SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Rutgers, The State University of New Jersey | Initiation date: Apr 2025 ➔ Aug 2025

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Dec 2025 ➔ Jun 2025

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

UroGen Presents uTRACT Registry at ASCO 2025 Annual Meeting Designed to Study Real-World Use of JELMYTO in Low-Grade Upper Tract Urothelial Cancer (Businesswire) - P=Obs | N=400 | uTRACT (NCT05874921) | Sponsor: UroGen Pharma Ltd. | "UroGen Pharma Ltd...today highlights the presentation of the uTRACT Registry study design at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. The uTRACT Registry is a single-arm, multicenter, prospective and retrospective study evaluating the real-world use of JELMYTO (mitomycin) for pyelocalyceal solution for the treatment of adult patients with low-grade upper tract urothelial carcinoma (LG-UTUC) across the United States....As of May 2025, the uTRACT Registry (NCT05874921) has enrolled 274 participants across 22 clinical sites nationwide, with a target enrollment of approximately 400 patients. Of these, about 340 are expected to have LG-UTUC, the population for which JELMYTO is FDA-approved."

Observational data • Real-world • Trial status • Urothelial Cancer

Mitomycin/BCG Combo Could Alleviate BCG Shortage Concerns for NMIBC (OncLive) - P3 | N=501 | ANZUP 1301 (NCT02948543) | "The intravesical combination of BCG plus mitomycin showed similar efficacy and safety to that of BCG alone for patients with non–muscle-invasive bladder cancer (NMIBC) but with the added benefit of using 40% fewer BCG doses than the monotherapy arm...With a median follow-up of 48 months (IQR, 34-64), the disease-free survival (DFS) rate at 2 years was 75% (95% CI, 70%-81%) with BCG plus mitomycin (n = 249) compared with 71% (95% CI, 65%-77%) for BCG alone (n = 252; HR, 0.87; 95% CI, 0.65-1.16; P = .34). The complete response (CR) rate at 3 months was 90% with the combination and 86% with BCG alone (RR, 1.05; 95% CI, 0.98-1.12; P = .22). Adverse effects (AEs) were similar between the 2 arms, with fewer flu-like symptoms seen in the combination arm."

P3 data • Bladder Cancer • Urothelial Cancer

UroGen Pharma Reports First Quarter 2025 Financial Results and Provides a Business Update (Businesswire) - "New Drug Application for UGN-102 on track for FDA-PDUFA target action date of June 13, 2025; assuming approval, commercial launch to immediately follow with product availability in July...JELMYTO achieved net product sales of $20.3 million in Q1 2025, compared with $18.8 million in Q1 2024, driven by underlying demand growth of 12%...Results from a post-hoc sub-analysis of the ENVISION trial, showing that tumor burden and the number of tumors did not significantly affect the CR rate or durability of response for patients treated with UGN-102, were presented at the ASCO Genitourinary Cancers Symposium (ASCO-GU 2025) in February 2025."

Launch US • P3 data • Sales • Urothelial Cancer

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

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

OLYMPUS Long-Term Follow-Up Study Reports Nearly Four-Year Duration of Response in Subset of Patients with Low-Grade Upper Tract Urothelial Cancer Who Achieved a Complete Response to Initial JELMYTO Treatment (Businesswire) - P3 | N=71 | OLYMPUS (NCT02793128) | Sponsor: UroGen Pharma Ltd. | "Data Presented at the 2025 American Urological Association Annual Meeting....Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41), the median duration of response was 47.8 months, irrespective of whether their cancer was new-onset or recurrent (median follow-up 28.1 months [95% CI 13.1, 57.5]). Of these patients, 21 had new-onset UTUC, and 20 had recurrent UTUC at baseline....Twenty patients entered long-term follow-up with a median follow-up of 53.3 months (95% CI 27.9, 65.3); median duration of response was not estimable (95% CI 43.5, not estimable) due to the low event rate....Investigators are currently enrolling participants in the JELMYTO uTRACT Registry (NCT05874921)....As of April 2025, 22 sites have been activated with 251 patients enrolled."

P3 data • Trial status • Urothelial Cancer

Emerging strategies: conservative management of upper tract urothelial carcinoma. (PubMed, Curr Opin Urol) - "The conservative management of UTUC is evolving, driven by advancements in imaging, molecular diagnostics, and minimally invasive treatments. While kidney-sparing approaches are increasingly utilized in low-risk patients, further prospective studies are needed to validate their efficacy."

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

Simulation Paired with Interdisciplinary Workflow to Prepare Oncology Nurses on Administration of Hazardous Drug via Nephrostomy Tube (ONS 2025) - "Jelmyto® is a chemotherapy treatment, which requires weekly instillation of mitomycin via nephrostomy tube for low-grade upper tract urothelial cancer...Simulation-based training with a multidisciplinary team approach is recommended to successfully implement education of hazardous drug administration via nephrostomy tube. Additional feedback will be obtained from nurses for follow-up to assess confidence long-term."

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

UroGen Announces Data Presentations at the American Urological Association 2025 Annual Meeting Highlighting Emerging Evidence Supporting Our Portfolio for Urothelial Cancers (Businesswire) - "UroGen Pharma Ltd...announced that data on investigational drug UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution and UGN-301 (zalifrelimab) will be presented at the American Urological Association (AUA) 2025 Annual Meeting being held in Las Vegas, Nevada from April 26-29."

Clinical data • Bladder Cancer • Urothelial Cancer

Long-term outcomes of treatment of recurrent or new-onset low-grade upper tract urothelial carcinoma with UGN-101, a mitomycin reverse thermal gel (AUA 2025) - P, P3 | "Patients with LG-UTUC who achieved CR after receiving treatment with UGN-101 experienced clinically meaningful long-term response, with a median DoR of almost 4 years, irrespective of whether their cancer was new onset or recurrent. The ongoing uTRACT registry (NCT05874921) will provide an opportunity to collect and evaluate real-world data in a larger sample, to further inform the use of UGN-101 in UTUC patients."

Oncology • Respiratory Diseases • Septic Shock • Solid Tumor • Urothelial Cancer