UroGen Pharma Ltd. URGN
UroGen Pharma Ltd. (Nasdaq: URGN) is an oncology drug developer. Its lead program, UGN-103 (mitomycin) for intravesical solution, is in Phase 3 for recurrent low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC). Its next catalyst on record is UGN-103: PDUFA target action date (June 2027).
Upcoming catalysts
- June 2027UGN-103 — PDUFA target action date
In October 2026, we announced the FDA's acceptance of the NDA and the assignment of a Prescription Drug User Fee Act ('PDUFA') target action date of June 14, 2027.
Next further out: UGN-103 LONGVIEW-HR — Phase 3 trial initiation in high-risk 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 (mitomycin) for intravesical solution | recurrent low-grade intermediate risk NMIBC | small molecule | Approved |
| Jelmyto (mitomycin) for pyelocalyceal solution | low-grade upper tract urothelial cancer (UTUC) | small molecule | Approved |
| UGN-103 (mitomycin) for intravesical solution | recurrent low-grade intermediate risk NMIBC | small molecule | Phase 3 |
| UGN-104 (mitomycin) for pyelocalyceal solution | low-grade UTUC | small molecule | Phase 3 |
| UGN-501 (oncolytic virus) | non-muscle invasive bladder cancer (NMIBC) | biologic-other | Phase 1 |
| UGN-103 LONGVIEW-HR trial | recurrent, papillary-only high-risk NMIBC | small molecule | Pre-clinical |
Recent results and decisions
- Oct 31, 2026accepted FDA accepted UroGen's NDA for UGN-103 for review with PDUFA goal date of June 14, 2027.
In October 2026, the FDA accepted for review UroGen's NDA for UGN-103 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.
Filing - 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
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.