Photo: UroGen / Chris Degnan, CFO
UroGen’s newest bladder-cancer medicine is bringing in more sales, but its older drug is losing ground. The split is shrinking the company’s losses while putting more weight on the new product to carry growth.
The Princeton, New Jersey-based biotechnology company reported November 4 that Zusduri generated $68 million in third-quarter revenue, up 35% from the preceding quarter. Total revenue reached $89 million, compared with $27.5 million a year earlier.
Yet UroGen cut its full-year sales forecast for Jelmyto, its treatment for a different urinary-tract cancer, to about $90 million from $97 million to $101 million. A government-related billing adjustment and competition for patients from clinical trials weighed on that business.
A wider network of prescribers
UroGen said 662 doctors had prescribed Zusduri by September 30, up from 452 at the end of June. Activated sites of care increased to 1,538 from 1,444. Those figures describe the medicine’s commercial reach, not patient cure rates.
Zusduri is approved for adults with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer. In plain terms, that is a defined group of patients whose cancer has come back without growing into the bladder’s muscle. It is not an approval for every type of bladder cancer.
The medicine releases mitomycin directly in the bladder and is given through a urinary catheter by a trained healthcare professional in an office or outpatient setting, according to the company’s treatment information. This week’s news is about sales and business performance, not a new approval or new proof of effectiveness.
Jelmyto’s weaker quarter lowers the outlook
Jelmyto sales fell to $21 million from $25.7 million in the third quarter of 2025. UroGen said the latest quarter included an unfavorable $1.5 million adjustment tied to a Centers for Medicare and Medicaid Services invoice under the discarded-drug program, including a prior-year true-up.
The company also said enrollment in competing U.S. clinical trials has affected patient starts for Jelmyto in low-grade upper-tract urothelial cancer. That is separate from the bladder-cancer population served by Zusduri.
For investors, the mixed result matters: rapid growth in one product can lift the whole company even while another product misses its earlier sales expectations. For patients, however, a rising sales number does not establish that a medicine is the right treatment for an individual case.
Loss narrows, but spending stays high
UroGen’s net loss narrowed to $1.5 million, or 3 cents a share, from $33.3 million, or 69 cents a share, a year earlier. Cash, cash equivalents and marketable securities totaled $90.5 million at September 30.
Research and development spending rose to $26 million from $14 million. Selling, general and administrative expenses rose to $47.2 million from $37.6 million, reflecting Zusduri’s commercial rollout and broader operations, the company said.
UroGen maintained its full-year operating-expense forecast of $260 million to $270 million but said spending is expected toward the upper end. That range includes non-cash share-based compensation.
The next medicine remains under review
In October, the FDA accepted UroGen’s application for UGN-103, a new mitomycin-based formulation, and set a target decision date of June 14, 2027. Acceptance means the application is being reviewed, not that the drug is approved.
The company also said the first patient began treatment in November in an early-stage Phase 1 trial of UGN-501, an investigational oncolytic virus for high-grade non-muscle-invasive bladder cancer. That trial is intended to test safety, tolerability and the feasibility of giving the treatment inside the bladder. Starting a trial does not establish clinical benefit.
JBizNews Desk | Princeton, N.J.
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