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UroGen Pharma (URGN) guidance and outlook
UroGen Pharma (URGN) lowered its guidance on Nov 4, 2026: Operating expenses $260M–$270M for FY2026. UroGen Pharma's 10-Q filed Nov 4, 2026 makes 29 forward-looking statements.
Guidance and outlook
Latest guidance
| Metric | Period | Range | Change |
|---|---|---|---|
| Revenue | FY2026 | $90.0M | lowered |
| Operating expenses | FY2026 | $260M–$270M | reaffirmed |
| Stock-based compensation | FY2026 | $20.0M–$24.0M | reaffirmed |
From the earnings release filed Nov 4, 2026 (8-K on EDGAR).
Forward-looking statements, 10-Q filed Nov 4, 2026
- We estimate that the annual treatable population of low-grade intermediate risk NMIBC in the United States is approximately 82,000, of which approximately 23,000 are estimated to be newly diagnosed and 59,000 are estimated to be recurrent patients.
- We estimate that the total addressable market opportunity for Zusduri in recurrent low-grade intermediate risk NMIBC is potentially over $5.0 billion.
- We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% of recurrent patients having five or more recurrences.
- We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% having five or more recurrences.
- (“medac”) to develop UGN-103 and UGN-104, which are next-generation investigational formulations of Zusduri and Jelmyto , respectively, that combine medac’s proprietary 80 mg mitomycin formulation with our RTGel technology, which we believe will provide advantages related to production, cost, supply and product convenience.
- In August 2026, we submitted an NDA for UGN-103 for the treatment of adults with recurrent low-grade intermediate risk NMIBC supported by the clinical data from the ongoing Phase 3 UTOPIA trial, and 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.
- We also plan to initiate a non-registrational trial in 2027 evaluating the use of UGN-103 as adjuvant therapy in the newly diagnosed intermediate-risk NMIBC population.
- We expect to complete enrollment in the Phase 3 trial of UGN-104 by the end of 2026 or in early 2027.
- We do not expect to incur significant additional costs related to this program going forward.
- The collaboration is intended to expand our oncology pipeline and provide access to an additional sustained-release drug delivery platform that may complement our existing expertise in localized therapy.
- We regularly review our research and development activities and, as necessary, reallocate resources among our programs, product candidates and external opportunities that we believe will best support the long-term growth of our business.
- We recognize costs incurred as the services are being provided by monitoring the status of the trial or project and the invoices received from our external service providers.
UroGen Pharma's latest quarter
UroGen Pharma, Q3 2026: revenue $89.0M (+224% year over year), operating margin 9.4%, net loss $1.5M, operating cash flow −$15.2M. The chart follows the revenue to costs, profit and cash.
Questions
Did UroGen Pharma raise or lower its guidance?
UroGen Pharma (URGN) lowered its guidance on Nov 4, 2026: Operating expenses $260M–$270M for FY2026.
What does UroGen Pharma expect?
We estimate that the annual treatable population of low-grade intermediate risk NMIBC in the United States is approximately 82,000, of which approximately 23,000 are estimated to be newly diagnosed and 59,000 are estimated to be recurrent patients. We estimate that the total addressable market opportunity for Zusduri in recurrent low-grade intermediate risk NMIBC is potentially over $5.0 billion. We estimate that approximately 68% of low-grade intermediate risk NMIBC patients have two or more recurrences, with approximately 23% of recurrent patients having five or more recurrences.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.