UroGen Pharma Ltd.
- Open
- 42.59
- Day high
- 43.46
- Day low
- 42.58
- Prev close
- 43.09
- Volume
- 49K
- Mkt cap
- $2.1B
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- -15.8
- P/S
- 11.1
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$3.7M over the last 3 months (0 open-market buys, 4 sales)
- 🏛Institutions reducing (13F)
UroGen Pharma Ltd. (URGN) is a Healthcare company listed on NASDAQ. The stock is up 117% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 4 sales (SEC Form 4).
UroGen Pharma Ltd. (URGN) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 4 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
URGN earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 5, 2026 | $-0.27 | $-0.28 | -5.7% | $72M | +14.0% |
| May 6, 2026 | $-0.56 | $-0.47 | +16.1% | $51M | +13.7% |
| Nov 6, 2025 | $-0.72 | $-0.69 | +4.2% | $27M | -31.5% |
| Aug 7, 2025 | $-0.82 | $-1.05 | -28.0% | $24M | -27.9% |
| Mar 10, 2025 | $-0.69 | $-0.80 | -15.9% | $25M | +5.2% |
| Aug 13, 2024 | $-0.82 | $-0.91 | -11.0% | $22M | -8.8% |
| Mar 14, 2024 | $-0.67 | $-0.72 | -7.5% | $24M | +4.3% |
| Nov 14, 2023 | $-0.89 | $-0.68 | +23.6% | $21M | -7.6% |
| Aug 10, 2023 | $-1.13 | $-1.03 | +8.8% | $21M | +5.1% |
| May 11, 2023 | $-1.39 | $-1.30 | +6.5% | $17M | +0.1% |
| Mar 16, 2023 | $-1.12 | $-1.22 | -8.9% | $18M | -2.3% |
| Nov 10, 2022 | $-1.22 | $-1.13 | +7.4% | $16M | -20.1% |
URGN insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Aug 28, 2026 | Robinson James A. Jr.director | Option | 2,000 | — |
| Aug 24, 2026 | Schoenberg Markofficer: Chief Medical Officer | Sell | 60,677 | $47.05 |
| Jul 10, 2026 | Schoenberg Markofficer: Chief Medical Officer | Sell | 10,000 | $40.00 |
| Jun 24, 2026 | Belldegrun Ariedirector | Grant | 20,000 | $34.99 |
| Jun 24, 2026 | Schoenberg Markofficer: Chief Medical Officer | Sell | 10,000 | $35.01 |
| Jun 24, 2026 | Wildman Daniel Georgedirector | Grant | 10,000 | $34.99 |
| Jun 24, 2026 | Wildman Daniel Georgedirector | Grant | 8,000 | — |
| Jun 24, 2026 | Robinson James A. Jr.director | Grant | 10,000 | $34.99 |
| Jun 24, 2026 | Robinson James A. Jr.director | Grant | 8,000 | — |
| Jun 24, 2026 | Holden Stuartdirector | Grant | 20,000 | $34.99 |
| Jun 24, 2026 | BUTITTA CYNTHIA Mdirector | Grant | 10,000 | $34.99 |
| Jun 24, 2026 | BUTITTA CYNTHIA Mdirector | Grant | 8,000 | — |
| Jun 24, 2026 | WEN LEANAdirector | Grant | 10,000 | $34.99 |
| Jun 24, 2026 | WEN LEANAdirector | Grant | 8,000 | — |
| Jun 9, 2026 | Schoenberg Markofficer: Chief Medical Officer | Sell | 5,222 | $27.30 |
Source: URGN SEC Form 4 filings, latest Aug 28, 2026. For informational purposes only — not investment advice.
See the full URGN insider & 13F page →UroGen Pharma Ltd. company profile
Overview
UroGen Pharma Ltd. (NASDAQ:URGN) is a biotechnology company founded in 2004 and based in Princeton, New Jersey, that specializes in developing and commercializing novel treatments for specialty cancers and urothelial diseases. The company went public in May 2017 and has established itself as a focused player in the urological oncology space, with its flagship product JELMYTO already commercialized and a promising pipeline of investigational therapies targeting various forms of bladder and upper tract cancers.
Business
UroGen operates in the specialized field of urological oncology, focusing on cancers that affect the urinary tract system including the bladder, ureters, and renal pelvis. The company's core innovation is RTGel, a proprietary reverse thermal gelation hydrogel technology that allows drugs to be delivered directly to the urinary tract and remain in contact with diseased tissue for extended periods. The company's primary commercial product is JELMYTO (mitomycin gel), which treats low-grade upper tract urothelial carcinoma - a rare form of cancer that occurs in the upper urinary tract. JELMYTO represents a significant advancement because it provides a non-surgical treatment option for patients who previously faced kidney removal as their primary treatment. The drug is administered directly into the affected area through a catheter, where the RTGel technology allows it to remain in contact with cancerous tissue for hours rather than minutes. UroGen's pipeline centers around UGN-102, an investigational treatment for intermediate-risk, low-grade non-muscle invasive bladder cancer. This represents a much larger market opportunity than JELMYTO, with an estimated 82,000 patients annually in the United States. The company is also developing UGN-103 as a next-generation version of UGN-102, UGN-104 as an improved version of JELMYTO, and UGN-301 for high-grade bladder cancer using immunotherapy approaches. Revenue is currently generated almost entirely from JELMYTO sales, which reached approximately $90 million in 2024, representing the company's sole commercial revenue stream.
Revenue model
UroGen generates revenue primarily through direct product sales of JELMYTO to hospitals, cancer centers, and urological practices. The company operates a specialized sales model targeting urologists and urological oncologists who treat patients with upper tract urothelial carcinoma. JELMYTO is priced as a premium specialty pharmaceutical, reflecting its status as the only FDA-approved non-surgical treatment option for its indication. The company's customers are healthcare institutions and physicians who purchase JELMYTO for direct patient administration. Reimbursement comes primarily from Medicare (approximately 70% of patients), private insurance, and Medicaid, with the company reporting approximately 99% reimbursement success rates. The drug benefits from favorable reimbursement dynamics due to its unique therapeutic profile and lack of alternatives. Several factors influence UroGen's margins and profitability potential. Positive margin drivers include the company's monopoly position in upper tract urothelial carcinoma treatment, premium pricing power due to the lack of alternatives, and relatively low manufacturing costs for the RTGel-based formulations. The specialized nature of urological oncology also creates high switching costs and physician loyalty once treatment protocols are established. However, margin pressures come from the high costs of maintaining a specialized sales force, ongoing clinical trial expenses for pipeline development, and the inherent limitations of rare disease markets. The company faces regulatory risks with its pipeline products, particularly UGN-102, where FDA approval is critical for accessing the much larger bladder cancer market. Additionally, as patents expire, generic competition could eventually pressure JELMYTO pricing, though the company is developing next-generation formulations to extend its competitive position.
Competitive moat
UroGen possesses a moderate but meaningful competitive moat built primarily around its proprietary RTGel technology platform and regulatory barriers. The company's RTGel hydrogel represents a unique drug delivery mechanism that is difficult to replicate, as it requires specific formulation expertise and has patent protection covering key aspects of the technology. This platform creates a technological moat that extends beyond any single drug product. The regulatory moat is particularly strong in the upper tract urothelial carcinoma space, where JELMYTO is the only FDA-approved non-surgical treatment option. The rare disease nature of this indication makes it economically unattractive for large pharmaceutical companies to develop competing products, creating a natural barrier to entry. Additionally, the specialized administration requirements and physician training needed for RTGel-based products create switching costs and relationship-based advantages. However, the moat faces several vulnerabilities. The company's patent portfolio, while valuable, will eventually expire, potentially opening the door to generic competition. More significantly, larger pharmaceutical companies with substantial resources could develop alternative drug delivery technologies or acquire competing platforms. In the broader bladder cancer market that UGN-102 targets, established players like Bristol Myers Squibb and Merck have significant competitive advantages in terms of resources, market access, and existing relationships with oncologists. The company's moat is strongest in niche urological applications but becomes more questionable as it moves into larger, more competitive oncology markets. The specialized nature of urological oncology provides some protection, but the company lacks the scale and resources of major pharmaceutical companies, making its long-term competitive position dependent on continued innovation and successful clinical execution.
Risks & safety
UroGen presents a moderate margin of safety profile with both strengths and vulnerabilities in its financial position. • Liquidity and Cash Position: Strong with $104 million in cash and short-term investments as of Q1 2025, providing approximately 2-3 years of operating runway at current burn rates • Debt and Solvency: Negative shareholders' equity of approximately $46 million due to accumulated losses, but strong current ratio of 5.6x indicates good short-term liquidity • Cash Burn: Operating cash flow negative $42 million in Q1 2025, with full-year 2025 operating expenses expected at $215-225 million • Valuation Metrics: Trading at negative P/E ratios due to losses, but EV/Revenue multiple appears reasonable for a commercial-stage biotech • Revenue Stability: JELMYTO provides steady recurring revenue base of ~$90-98 million annually with 8-12% growth trajectory • Key Risk: Heavy dependence on UGN-102 FDA approval (PDUFA date June 13, 2025) for future growth and path to profitability
Recent development
Over the past few years, UroGen has executed a focused strategy of advancing its RTGel platform from a single-product company toward a diversified urological oncology portfolio. The most significant development has been the completion of Phase 3 clinical trials for UGN-102, with the ATLAS and ENVISION trials both meeting their primary endpoints and demonstrating an 80.6% complete response rate at 18 months. The company submitted its New Drug Application (NDA) for UGN-102 in August 2024, with FDA acceptance and a PDUFA target date of June 13, 2025. Commercially, UroGen has steadily grown JELMYTO revenues from $64 million in 2022 to $90 million in 2024, representing consistent double-digit growth despite the rare disease market constraints. The company has expanded its commercial infrastructure in preparation for UGN-102's potential launch, growing its sales force from approximately 42 representatives to over 80, targeting the significantly larger intermediate-risk bladder cancer market. The company has also diversified its pipeline through strategic acquisitions and partnerships. In 2024, UroGen acquired UGN-501 (formerly ICVB-1042), a next-generation oncolytic virus from IconOVir, expanding into immuno-oncology approaches. The company initiated the Phase 3 UTOPIA trial for UGN-103 in late 2024, positioning this next-generation candidate as a potential successor to UGN-102. Financially, UroGen has strengthened its balance sheet through multiple capital raises, including a $116 million public offering in 2024, providing sufficient runway to reach potential profitability through successful UGN-102 commercialization. The company has also secured strategic partnerships, including licensing agreements with medac and Pharmakon Advisors, to support its development programs and provide additional financial flexibility.
URGN company profile · for informational purposes only — not investment advice.
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