UroGen Pharma recently released its 10-Q report. The company is a biotechnology firm focused on urothelial and specialty cancers, built around its RTGel hydrogel platform and products including Jelmyto and Zusduri, both mitomycin-based treatments delivered locally to the urinary tract. It is also advancing UGN-103, UGN-104 and early-stage programs such as UGN-301, including combinations with UGN-201 and gemcitabine.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
UroGen’s MD&A says the company’s discussion should be read alongside its unaudited condensed consolidated financial statements and the audited 2025 annual report filed on March 2, 2026. The section also repeats the company’s forward-looking statements language, noting that projections on strategy, revenues, costs, prospects and plans may not be achieved and that actual results could differ materially.
The company’s core commercial story in the quarter centered on two approved products and a pipeline built around RTGel. Jelmyto, approved in April 2020 for adult patients with low-grade upper tract urothelial cancer, uses mitomycin plus sterile hydrogel to extend drug exposure in the urinary tract. UroGen says Jelmyto’s U.S. orphan drug exclusivity runs until April 15, 2027, while the main U.S. patents listed in the Orange Book expire in January 2031.
Zusduri received FDA approval on June 12, 2025 for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer. UroGen says the annual treatable U.S. population for that indication is about 82,000 patients, including roughly 23,000 newly diagnosed patients and 59,000 recurrent patients. The company estimates the addressable market opportunity for recurrent low-grade intermediate risk NMIBC at more than $5.0 billion.
UroGen describes RTGel as a liquid at lower temperatures that turns into a gel at body temperature, creating a temporary reservoir that slows drug loss from the urinary tract. In the company’s example, standard aqueous mitomycin remains in the upper urinary tract for about five minutes, while mitomycin formulated with RTGel can dwell for about four to six hours. UroGen also says RTGel can support higher mitomycin loading, citing 0.5 mg per 1 mL of water versus up to 8 mg per 1 mL of RTGel.
For Jelmyto, UroGen cites Phase 3 data showing a complete response rate of 58%, or 41 of 71 patients, in the intent-to-treat population. At the 12-month durability assessment, 23 of those 41 patients remained in complete response, eight had recurrence, and ten could not be evaluated. The company says Kaplan-Meier durability was 81.8% at 12 months, with median duration of response not reached. The most common adverse events, each reported in at least 20% of patients, included ureteric obstruction, flank pain, urinary tract infection, hematuria, abdominal pain, fatigue, renal dysfunction, nausea, dysuria and vomiting.
UroGen also highlighted longer-term follow-up data from the Olympus trial presented in February 2025. Among the 41 patients who achieved complete response after primary chemoablation with Jelmyto, and the 20 who entered long-term follow-up, the median duration of response was 47.8 months, based on a median follow-up of 28.1 months.
On the commercial side, UroGen said its Jelmyto launch began in June 2020 and that its customer-facing team totals about 160 employees. The company said Medicare patients with supplemental coverage are covered and that most commercial plans have policies in place to cover Jelmyto. It also said it has agreements with national, regional and local mixing pharmacies to prepare and dispense the drug, and that the FDA extended Jelmyto’s in-use period from eight hours to 96 hours in September 2022.
The company said CMS issued a permanent, product-specific J-code for Jelmyto effective January 1, 2021, replacing the earlier C-code. CMS also granted Jelmyto a New Technology Ambulatory Payment Classification effective October 1, 2023. UroGen said it has launched a registry to collect real-world outcomes data for UTUC patients treated with Jelmyto.
For Zusduri, UroGen said the product is delivered directly into the bladder through a urinary catheter in an outpatient procedure. The company contrasts that with TURBT, the surgical standard of care, which is typically performed under general anesthesia and may require an overnight stay. UroGen says repeated TURBT procedures are common in this disease setting, with about 68% of low-grade intermediate risk NMIBC patients experiencing two or more recurrences and about 23% experiencing five or more recurrences. The market has reacted to these announcements by moving the company's shares 4.91% to a price of $25.00. For more information, read the company's full 10-Q submission here.
