UroGen Pharma Ltd (URGN) is an innovative biotechnology company focused on the development of advanced therapies for urological diseases, including urothelial carcinoma and bladder cancer. Leveraging its proprietary reverse thermal gel technology, the company enables targeted, sustained drug delivery, maximizing treatment efficacy while reducing systemic side effects. UroGen's strong clinical pipeline underscores its commitment to addressing substantial unmet medical needs in the oncology space, positioning the company as a potential leader in the urological oncology market and significantly improving patient outcomes.
| Revenue (TTM) | $250.25M |
| Gross Profit (TTM) | $228.75M |
| EBITDA | $-30.63M |
| Operating Margin | 9.36% |
| Return on Equity | -1481.00% |
| Return on Assets | -8.46% |
| Revenue/Share (TTM) | $5.00 |
| Book Value | $-2.55 |
| Price-to-Book | 19.27 |
| Price-to-Sales (TTM) | 5.04 |
| EV/Revenue | 5.47 |
| EV/EBITDA | -2.63 |
| Quarterly Earnings Growth (YoY) | 0.00% |
| Quarterly Revenue Growth (YoY) | 223.90% |
| Shares Outstanding | $49.05M |
| Float | $43.56M |
| % Insiders | 3.48% |
| % Institutions | 97.87% |
Volatility is currently expanding
Urogen Pharma NASDAQ: URGN reported third-quarter revenue of $89 million, more than triple the $27.5 million recorded a year earlier, as sales of bladder cancer treatment ZUSDURI continued to grow. The company said it expects to achieve profitability and generate positive cash flow in the fourth quarter of 2026.
Zosturi quarterly net product revenue reached $68 million. Repeat prescribers expanded to 50% of total Zosturi writers.
Urogen Pharma (URGN) came out with a quarterly loss of $0.03 per share versus the Zacks Consensus Estimate of $0.05. This compares to a loss of $0.69 per share a year ago.
ZUSDURI ® generated $68.0 million in revenue in the third quarter of 2026, representing 35% quarter-over-quarter growth The FDA accepted UroGen's NDA for UGN-103 (next-generation novel mitomycin-based formulation) for review; PDUFA goal date set for June 14, 2027 Announced first patient dosed in the UGN-501 Phase 1 trial Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Nov. 04, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.
PRINCETON, N.J., Nov. 03, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.
Phase 1 clinical trial to evaluate local intravesical administration of UGN-501 UGN-501 is a differentiated investigational next-generation oncolytic virus designed to combine direct tumor cell destruction with anti-tumor immune activation PRINCETON, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.
PRINCETON, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-103 (mitomycin) for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.
UroGen Pharma has pulled back 30% after a 208% rally, driven by Zusduri's strong launch as the only approved non-surgical LG-IR-NMIBC therapy. Zusduri's rapid uptake, favorable patient preference, and robust clinical data support continued growth, with patent protection until 2044 and 95% reimbursement coverage. URGN faces looming clinical competition but currently only contends with TURBT, positioning it for robust growth through at least 2027.
UroGen's Zusduri sales surge, Jelmyto revenues and advancing pipeline assets strengthen its shift toward a commercial growth story.
UroGen Pharma Ltd. has transitioned into a commercial-stage biopharma, driven by strong adoption of Zusduri for recurrent non-muscle invasive bladder cancer. Zusduri achieved an 80% complete response rate in the ENVISION trial, with a 64.5% chance of remaining disease-free at 3 years among responders. URGN-103, a next-generation mitomycin-based product, is positioned to replace Zusduri, offering manufacturing and convenience advantages; NDA submission is complete and approval is likely.
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