UroGen Pharma Ltd. URGN
UroGen Pharma Ltd. (Nasdaq: URGN) is an oncology drug developer. Its lead program, Zusduri (mitomycin intravesical solution) and Jelmyto (mitomycin pyelocalyceal solution), is in Phase 3 for Recurrent low-grade intermediate risk NMIBC; low-grade UTUC. Its next catalyst on record is UGN-501: Begin Phase 1 trial in NMIBC (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: UGN-501 — Begin Phase 1 trial in NMIBC (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Zusduri (UGN-102) | Recurrent low-grade intermediate risk NMIBC | small molecule | Approved |
| Jelmyto (UGN-101) | Low-grade upper tract urothelial cancer | small molecule | Approved |
| UGN-103 (mitomycin, medac 80 mg formulation + RTGel) | Recurrent low-grade intermediate risk NMIBC | small molecule | Phase 3 |
| UGN-104 (mitomycin, medac 80 mg formulation + RTGel) | Low-grade UTUC | small molecule | Phase 3 |
| UGN-501 (oncolytic virus) | NMIBC | gene therapy | Pre-clinical |
Recent results and decisions
- Aug 5, 2026positive Updated ENVISION results: 36-month duration of response 64.5% (KM) among 3-month complete responders (79.6% CR rate); median DOR not reached at 35.5 months.
Updated results from the Phase 3 ENVISION trial of ZUSDURI showed a 36-month duration of response (DOR) of 64.5% (95% CI: 54.6, 72.8) by Kaplan-Meier estimate among patients who achieved a complete response (CR) at three months (79.6%).
Filing - Aug 5, 2026positive UTOPIA six-month DOR of 94.5% (KM), consistent with 91.9% seen with ZUSDURI in ENVISION.
UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) DOR at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial in patients with LG-IR-NMIBC.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.