Jelmyto (mitomycin urothelial gel) / UroGen - LARVOL DELTA

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

ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) (AUA 2026) - P1, P3 | "More recently, mitomycin C gel (Jelmyto) became the first approved pharmacologic therapy for LG UTUC, representing an important advance in organ-sparing care. Enrollment is planned for 100 patients; as of February 1, 2026, 81 patients have been treated and 63 have completed PRE. The most recent DSMB review on October 30, 2025 recommended continuation of the study as planned.By integrating a drug-activated, vascular-targeted, non-thermal mechanism, Padeliporfin VTP has the potential to expand organ-sparing treatment options for LG UTUC and influence future clinical practice."

P3 data • Oncology • Solid Tumor • Urology • Urothelial Cancer

Therapeutic landscape of upper tract urothelial carcinoma: Intraluminal agents, perioperative chemotherapy, and immunotherapy. (PubMed, Urol Oncol) - "UTUC management is evolving towards stage-specific strategies integrating chemoablation, systemic therapy, and molecularly guided approaches. Future priorities include randomized trials, optimized drug delivery, and long-term safety evaluation."

IO biomarker • Journal • Review • Bladder Cancer • Genito-urinary Cancer • 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 | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • Appendix Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF

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 | Trial completion date: May 2030 ➔ May 2035

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

JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC (The Manila Times) - "Generated net product revenue of $22.0 million in the quarter ended June 30, 2026, compared with $24.2 million reported for the second quarter of 2025. The Company continues to add new users and remains on track to deliver within its JELMYTO full-year 2026 guidance range of $97 million to $101 million."

Sales • Sales projection • Urothelial Cancer

UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO (mitomycin) for pyelocalyceal solution (Yahoo Finance) - "his Agreement resolves the patent litigation UroGen initiated in response to Teva’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration ('FDA') seeking approval to market a generic version of JELMYTO (mitomycin) for pyelocalyceal solution prior to the expiration of the relevant Company patents...Under the terms of the Agreement, UroGen will grant Teva a non-exclusive license to sell its generic version of JELMYTO beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur....JELMYTO has regulatory exclusivity through April 15, 2027, and is covered by Orange Book-listed patents expiring on January 20, 2031."

Licensing / partnership • Patent expiry • Urothelial Cancer

A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial (clinicaltrials.gov) - P2 | N=11 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=95 ➔ 11 | Trial completion date: Jun 2026 ➔ May 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2026

Enrollment change • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Implementing Jelmyto® Treatment for Low-Grade Upper Tract Urothelial Cancer in an Outpatient Infusion Center: A Multidisciplinary Nursing-Led Initiative (ONS 2026) - "The project not only expanded treatment options for LG-UTUC patients but also established a replicable model for future novel therapies. Ongoing evaluation and refinement will continue as more patients are treated."

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

Mitomycin Mastery Building Nursing Competency in Jelmyto (Mitomycin) Administration via Nephrostomy Tube for Urothelial Cancer (ONS 2026) - "This checklist could be utilized for future administrations of this medication and can help with training new RNs to this complex skill. Detailed and organized skills checklists are being designed for other antineoplastic therapies that require special administration and preparation and helps the nurse improve their competency and comfort with administering innovative and complex medications to treat cancer."

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

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

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

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 | Initiation date: May 2026 ➔ Oct 2025

Trial initiation date • Bladder Cancer • 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 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Anal Carcinoma • Colorectal Cancer • Human Immunodeficiency Virus • Infectious Disease • Oncology • Rectal Cancer • Solid Tumor • Squamous Cell Carcinoma • CD4 • IFNG

Mitomycin Gel for the Pyelocaliceal System in Patients With Urinary Diversion: First Reported Cases and Operative Technique. (PubMed, Case Rep Urol) - "Our series highlights the potential role of UGN-101 in patients with UTUC and pre-existing urinary diversion. Antegrade instillation of UGN-101 can be tailored to specific disease locations and should be considered for patients with a history of urinary diversion who are not candidates for extirpative surgery."

Journal • Oncology • Solid Tumor • Urothelial Cancer

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

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

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