UGN-104 / UroGen - LARVOL DELTA

UroGen Announces...Reports Fourth Quarter and Full Year 2025 Financial Results (GlobeNewswire) - "UroGen plans to submit the NDA in the second half of 2026 with potential FDA approval in 2027....The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing and is expected to be fully enrolled by the end of 2026."

Enrollment status • FDA approval • FDA filing • Bladder Cancer • 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

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer (clinicaltrials.gov) - P3 | N=70 | Recruiting | Sponsor: UroGen Pharma Ltd. | N=50 ➔ 70 | Trial completion date: Mar 2027 ➔ Oct 2027 | Trial primary completion date: Mar 2026 ➔ Oct 2026

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

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: UroGen Pharma Ltd. | Not yet recruiting ➔ Recruiting

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

UroGen Pharma Reports First Quarter 2025 Financial Results and Provides a Business Update (Businesswire) - "Enrollment is ongoing in the Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC and enrollment is expected to be completed by mid-2025....UroGen plans to initiate a Phase 3 trial to explore the safety and efficacy of UGN-104 by mid-2025. UGN-104 is a next generation investigational product for LG-UTUC."

Enrollment status • New P3 trial • Urothelial Cancer

UroGen Pharma Reports Fourth Quarter and Full Year 2024 Financial Results… (Businesswire) - "JELMYTO achieved net product revenue of $90.4 million in 2024, compared with $82.7 million in 2023, driven by underlying demand revenue growth of 12% for 2024 and 15% for Q4 2024....UroGen plans to initiate a Phase 3 trial to explore the safety and efficacy of UGN-104, its next generation product for LG-UTUC in the first half of 2025."

Sales • Trial status • Bladder Cancer • Urothelial Cancer

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer (clinicaltrials.gov) - P3 | N=50 | Not yet recruiting | Sponsor: UroGen Pharma Ltd.

New P3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

UroGen Receives New U.S. Patent Allowance for Next-Generation Mitomycin-Based Products Expected to Provide Protection Until December 2041 (Businesswire) - "UroGen Pharma Ltd...announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/535,108 entitled 'Material and Method for Treating Cancer'. The allowed claims relate to the combination of UroGen’s RTGel technology with medac’s licensed proprietary lyophilized mitomycin formulation and cover the use of UroGen’s UGN-103 and UGN-104 development programs in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively. The U.S. patent, once issued, will have an expiration date in December 2041."

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

UroGen Pharma…Reports 2024 Second Quarter Financial Results and Business Highlights (Businesswire) - "JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC): Generated net product revenue of $21.8 million in the second quarter of 2024, compared to $21.1 million in the second quarter of 2023....UroGen has initiated the Phase 3 study and has onboarded three clinical sites to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study of UGN-104 in LG-UTUC early next year."

New P3 trial • Sales • Trial status • Bladder Cancer • Urothelial Cancer

UroGen Pharma Delivers Double Digit JELMYTO Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102 (Businesswire) - "UGN-102 (mitomycin) for intravesical solution:...The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA. The company plans to complete the submission in September 2024....Next-generation novel mitomycin-based formulation for urothelial cancers:...UroGen plans to initiate Phase 3 studies to explore the safety and efficacy of UGN-103 and UGN-104 in LG-IR-NMIBC and LG-UTUC, respectively, in 2024."

NDA • New P3 trial • Bladder Cancer • Urothelial Cancer