UroGen Pharma Ltd.
URGN evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for URGN—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · URGN
UroGen Pharma Ltd. is a biopharmaceutical company focused on developing and commercializing therapies for urological cancers, with two FDA-approved products (Jelmyto and Zusduri) and a pipeline of candidates in clinical trials.
Key risk: Negative shareholders' equity
BioSniper Score
Based on 6 of 6 signals
Market Cap
$2.13B
Cash Runway
13.2 moLead Asset
jelmyto (Approved)Next Catalyst
Phase3_Topline · Sep 1, 2026Financial data as of Jun 30, 2026.
Tracking 7 pipeline candidates · 5 clinical trials · 6 catalysts · 2 FDA decisions for UroGen Pharma Ltd..
UroGen Pharma Ltd. is a biopharmaceutical company focused on developing and commercializing therapies for urological cancers, with two FDA-approved products (Jelmyto and Zusduri) and a pipeline of candidates in clinical trials.
- UroGen has two FDA-approved products: Jelmyto and Zusduri (approved June 2025 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer) [sec · filed 2026-04-30].
- Zusduri net sales were $15.8 million in 2025, reflecting the initial launch period before a permanent J Code became effective January 1, 2026 [sec · filed 2026-04-30].
- As of June 30, 2026, the company had cash and equivalents of $79.1 million, total revenue of $72.5 million, net income of -$14.4 million, shareholders' equity of -$105.5 million, and total debt of $200.0 million [latest reported financials].
- The company has an accumulated deficit of $997.6 million as of June 30, 2026 [sec_mda · as of 2026-08-05].
- Pipeline candidates include UGN-103, UGN-104, and UGN-501 in clinical development for non-muscle invasive bladder cancer [sec_mda · as of 2026-08-05].
What works
- Zusduri is the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, addressing an unmet need [sec · filed 2026-04-30].
- The company has a commercial infrastructure with two marketed products (Jelmyto and Zusduri) generating revenue [sec · filed 2026-04-30].
- UGN-102 (Zusduri) pivotal ENVISION trial showed a 12-month duration of response of 82.3% (95% CI, 75.9%, 87.1%) by Kaplan-Meier estimate [sec · filed 2025-07-15].
What to weigh
- The company has incurred losses since inception, with an accumulated deficit of $997.6 million as of June 30, 2026 [sec_mda · as of 2026-08-05].
- Shareholders' equity is negative (-$105.5 million as of June 30, 2026), indicating a deficit in net assets [latest reported financials].
- The company expects to finance cash needs through equity or debt financings, which may dilute shareholders or increase leverage [sec_mda · as of 2026-08-05].
- Combined Jelmyto/Zusduri revenue target for 2025 was not achieved, per corporate performance metrics [sec · filed 2026-04-30].
From the filings
Quoted directly from source documents.
Zusduri is the first and only FDA-approved medicine for recurrent low-grade intermediate-risk NMIBC
“the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.”
SEC filings · April 30, 2026
Accumulated deficit as of June 30, 2026
“as of June 30, 2026, we had an accumulated deficit of $997.6 million.”
SEC MD&A · August 5, 2026
UGN-102 ENVISION trial 12-month duration of response
“12-month duration of response of 82.3% (95% CI, 75.9%, 87.1%), by Kaplan-Meier estimate”
SEC filings · July 15, 2025
Catalyst timeline
- 2026-09-01 · Phase3_Topline — Phase 3 Topline: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel For — Topline data from the Phase 3 study of UGN-103 will be a key readout for the pipeline.
- 2026-09-30 · Phase1_Start — Phase 1 Start: A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacoki — Initiation of the Phase 1 study for UGN-103 will mark the start of early clinical testing.
- 2028-03-01 · Phase3_Topline — Phase 3 Topline: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel For — Topline data from the Phase 3 study of UGN-104 will provide efficacy and safety results.
- 2028-03-01 · Phase3_Topline — Phase 3 Topline: A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary C — Topline data from the Phase 3 study of UGN-102 will inform its potential as a primary treatment.
- 2031-01-20 · Patent_Expiry · JELMYTO — Patent/Exclusivity Expiry: JELMYTO — Patent expiry for Jelmyto could open the market to generic competition.
- 2031-01-20 · Patent_Expiry · ZUSDURI — Patent/Exclusivity Expiry: ZUSDURI — Patent expiry for Zusduri could affect future revenue exclusivity.
Risks & what to watch (4)›
Key risks
- Negative shareholders' equity — Shareholders' equity of -$105.5 million as of June 30, 2026 indicates a deficit in net assets [latest reported financials].
- Dependence on external financing — Company expects to finance cash needs through equity or debt financings, which may dilute or increase debt [sec_mda · as of 2026-08-05].
- Clinical trial delays or failures — Progress of UGN-103, UGN-104, and UGN-501 trials is uncertain and could affect pipeline [sec_mda · as of 2026-08-05].
- Patent expirations for key products — Patent/exclusivity expiry for Jelmyto and Zusduri is expected in 2031, potentially impacting revenue [upcoming catalysts].
What to watch
- Phase 3 topline data for UGN-103 expected September 2026 [upcoming catalysts].
- Phase 1 start for UGN-103 expected September 2026 [upcoming catalysts].
- Phase 3 topline data for UGN-104 and UGN-102 expected March 2028 [upcoming catalysts].
- Commercial adoption of Zusduri following permanent J Code effective January 1, 2026 [sec · filed 2026-04-30].
Sources: SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
13.2 months
OCF -$33M · Net income -$14M
Lead: Approved
7 candidates
6 upcoming, next in ~2d
0 buys · 4 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
169
Total value held
$708.0M
| Holder | Shares | Value |
|---|---|---|
| rtw investments, lp | 4,543,895 | $81.7M |
| blackrock, inc. | 2,845,567 | $51.2M |
| toronto dominion bank | 2,616,714 | $47.0M |
| morgan stanley | 2,560,038 | $46.0M |
| acorn capital advisors, llc | 1,673,420 | $30.1M |
| american century companies inc | 1,637,570 | $29.4M |
| silverarc capital management, llc | 1,503,045 | $27.0M |
| opaleye management inc. | 1,430,000 | $25.7M |
| frontier capital management co llc | 1,314,112 | $23.6M |
| menora mivtachim holdings ltd. | 1,152,531 | $20.7M |
Showing top 10 of 169 institutional holders of UroGen Pharma Ltd.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 15.2%
- Days to cover
- 9.3
- Shares short
- 7,236,438
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
URGN short interestGovernance
Frequently asked questions
What is the AI investment thesis for UroGen Pharma Ltd.?
UroGen Pharma Ltd. is a biopharmaceutical company focused on developing and commercializing therapies for urological cancers, with two FDA-approved products (Jelmyto and Zusduri) and a pipeline of candidates in clinical trials.
What is UroGen Pharma Ltd.'s lead drug candidate?
UroGen Pharma Ltd.'s most advanced tracked candidate is jelmyto (Approved) for low-grade upper tract urothelial cancer.
What is UroGen Pharma Ltd.'s next catalyst?
UroGen Pharma Ltd.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel For" — expected September 1, 2026.
Who is the CEO of UroGen Pharma Ltd.?
Ms. Elizabeth A. Barrett is the chief executive officer of UroGen Pharma Ltd. (URGN).
Where is UroGen Pharma Ltd. headquartered?
UroGen Pharma Ltd. (URGN) is headquartered in Princeton, NJ, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.