UroGen Pharma UGN-103 Achieves 94.5% Durability of Response at Six Months
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 15 2026
0mins
UroGen Pharma announced UGN-103 achieved a 94.5% durability of response at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial of UGN-103 for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The six-month results from UTOPIA are generally consistent with the 91.9% six-month DOR observed with Zusduri for intravesical therapy in its pivotal ENVISION trial. Zusduri is the first and only treatment approved by the FDA for adult patients with recurrent LG-IR-NMIBC. Based on the consistency of UTOPIA data with the results of the ENVISION trial studying Zusduri in patients meeting the same eligibility criteria and alignment with the FDA, UroGen remains on track to submit a new drug application for UGN-103 in the third quarter of 2026.
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Analyst Views on URGN
Wall Street analysts forecast URGN stock price to rise
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 37.410
Low
31.00
Averages
40.25
High
55.00
Current: 37.410
Low
31.00
Averages
40.25
High
55.00
About URGN
UroGen Pharma Ltd. Is an Israel-based biopharmaceutical company. The Company is engaged in building solutions for cancers and urologic diseases. UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. Its lead product candidates include MitoGel and VesiGel are formulated using its proprietary reverse thermally triggered hydrogel, or RTGel, technology. MiroGel ( UGN-101) is a sustained release formulation of the chemotherapy agent Mitomycin C for the treatment of low-grade upper tract urothelial carcinoma, an urothelial cancer in the upper tract. VesiGel (UGN-102) is a sustained release formulation of a high dose Mitomycin C for the treatment of low grade non-muscle invasive bladder cancer (LG-NMIBC).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Analysis of Biotech Companies' Stock Performance
- Climb Bio Progress: Climb Bio continues to advance its clinical pipeline with ongoing enrollment in the Phase 2 PrisMN trial and Phase 1b/2a studies, which are expected to enhance its market position in immune-mediated diseases.
- Positive Clinical Data: In June 2026, Climb Bio reported initial clinical data for Budoprutug, demonstrating a favorable safety and tolerability profile, which may solidify its future market presence and boost investor confidence.
- Tectonic Therapeutic Trials Initiated: Tectonic Therapeutic launched a Phase 1a clinical trial for TX2100 in February 2026 targeting hereditary hemorrhagic telangiectasia, which is anticipated to create new growth opportunities for the company.
- UroGen Pharma Drug Approval: UroGen Pharma received FDA approval for Zusduri in June 2025, further enhancing its competitiveness in the low-grade non-muscle invasive bladder cancer market, which is expected to significantly boost company revenues.
See More
UroGen Pharma Shares Surpass Analyst Target Price
- Stock Performance: UroGen Pharma Ltd's shares recently surpassed the average analyst 12-month target price of $36.88, trading at $37.94, indicating optimistic market sentiment that may attract more investor interest.
- Analyst Reaction: When a stock reaches an analyst's target price, they typically either downgrade or raise their target; the current market response to UroGen could significantly influence its future price trajectory, especially if the company's fundamentals are improving.
- Target Price Distribution: Among analysts covered by Zacks, UroGen's average target price is $36.88, but there is considerable variance, with a low target of $18.00 and a high of $45.00, resulting in a standard deviation of $8.724, reflecting differing market perspectives on its future performance.
- Investor Decision-Making: The stock's rise above the target price provides a signal for investors to reassess the company, weighing whether the current valuation is justified or if it is time to consider reducing their holdings in anticipation of potential market fluctuations.
See More
UroGen CMO Sells Shares Amid Strategic Developments
- Share Sale Details: Mark Schoenberg, CMO of UroGen Pharma, sold 10,000 shares on June 22, 2026, at an average price of $35.01 per share, totaling approximately $350,000, which reduced his direct holdings by 7.15% from 139,763 to 129,763 shares, indicating continued confidence in the company.
- Sales Growth: UroGen's Zusduri product saw a significant sales increase to $29.2 million in Q1 2026 from $15.8 million in Q4 2025, reflecting strong performance in the oncology market, while Jelmyto sales are projected to rise from $94 million in 2025 to between $97 million and $101 million, further solidifying market presence.
- Improving Losses: Although UroGen is still reporting losses, the Q1 2026 loss of $23.6 million represents a substantial decrease from $43.8 million in the same period last year, indicating improved financial health that may attract more investor interest.
- New Treatment Prospects: UroGen is developing UGN-103 as a new treatment option for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, featuring simpler manufacturing and reconstitution processes, which could provide better treatment solutions for patients and enhance the company's competitive edge in the market.
See More
UroGen Pharma CMO Sells Shares in Open Market Transaction
- Transaction Overview: UroGen Pharma's CMO Mark Schoenberg sold 10,000 shares for $350,100 on June 22, 2026, aligning with his typical trade size of around 9,000 shares, indicating a routine liquidity management strategy.
- Ownership Change Analysis: This sale reduced Schoenberg's direct holdings by 7.15%, yet he retains 129,763 shares, reflecting ongoing confidence in UroGen and a significant shareholder position.
- Sales Growth Momentum: UroGen's Jelmyto product is projected to increase sales from $94 million in 2025 to between $97 million and $101 million in 2026, while Zusduri's sales soared to $29.2 million in Q1 2026, up from $15.8 million in Q4 2025.
- Loss Reduction Trend: Although UroGen continues to report losses, the $23.6 million loss in Q1 2026 represents a significant decrease from $43.8 million in the same period last year, indicating positive progress in improving financial health.
See More
UroGen Pharma Executive Stock Transaction Overview
- Executive Stock Sale: UroGen Pharma's Chief Medical Officer Mark Schoenberg sold 5,222 ordinary shares for approximately $143,000, indicating a need for liquidity while reducing his direct holdings to 139,763 shares, suggesting continued confidence in the company's future.
- Options Exercise and Sale: Schoenberg exercised 10,000 options before immediately selling a portion of the shares to secure liquidity, reflecting his astute market awareness and financial management strategy.
- Market Performance and Risks: Despite UroGen Pharma's stock rising 168.23% over the past year, the recent settlement with Teva Pharmaceuticals for a non-exclusive license to sell generic Jelmyto may pose future competitive risks, prompting investors to proceed with caution.
- Sales Growth and Product Outlook: First-quarter sales of Jelmyto increased by 7% year-over-year to $21.7 million, accounting for 42.5% of total revenue, while another treatment, Zusduri, saw a significant 109% increase in sales to $29.2 million, showcasing the company's potential in navigating market competition.
See More
UroGen Pharma Executive Reduces Shareholding
- Share Reduction Transaction: Mark Schoenberg sold 5,222 ordinary shares on June 8, 2026, for approximately $143,000 at a weighted average price of $27.30 per share, reducing his direct holdings by 3.60% from 144,985 to 139,763 shares.
- Holding Proportion Change: Following this sale, Schoenberg's holdings are now approximately 62.5% of the September 2023 level, indicating a potential weakening of his direct investment intent in the company, which could affect market confidence in UroGen Pharma.
- Product Sales Performance: UroGen Pharma's Jelmyto saw a 7% year-over-year increase in first-quarter sales to $21.7 million, accounting for 42.5% of total revenue, but faces competition from Teva Pharmaceuticals' upcoming generic version, which may impact future revenues.
- Market Outlook Warning: Although UroGen Pharma's other drug, Zusduri, experienced a significant 109% year-over-year sales increase to $29.2 million in the first quarter, analysts advise caution for investors considering the stock, as it was not included in The Motley Fool Stock Advisor's list of top investment picks.
See More
Analysis of Biotech Companies' Stock Performance
- Climb Bio Progress: Climb Bio continues to advance its clinical pipeline with ongoing enrollment in the Phase 2 PrisMN trial and Phase 1b/2a studies, which are expected to enhance its market position in immune-mediated diseases.
- Positive Clinical Data: In June 2026, Climb Bio reported initial clinical data for Budoprutug, demonstrating a favorable safety and tolerability profile, which may solidify its future market presence and boost investor confidence.
- Tectonic Therapeutic Trials Initiated: Tectonic Therapeutic launched a Phase 1a clinical trial for TX2100 in February 2026 targeting hereditary hemorrhagic telangiectasia, which is anticipated to create new growth opportunities for the company.
- UroGen Pharma Drug Approval: UroGen Pharma received FDA approval for Zusduri in June 2025, further enhancing its competitiveness in the low-grade non-muscle invasive bladder cancer market, which is expected to significantly boost company revenues.
See More
UroGen Pharma Shares Surpass Analyst Target Price
- Stock Performance: UroGen Pharma Ltd's shares recently surpassed the average analyst 12-month target price of $36.88, trading at $37.94, indicating optimistic market sentiment that may attract more investor interest.
- Analyst Reaction: When a stock reaches an analyst's target price, they typically either downgrade or raise their target; the current market response to UroGen could significantly influence its future price trajectory, especially if the company's fundamentals are improving.
- Target Price Distribution: Among analysts covered by Zacks, UroGen's average target price is $36.88, but there is considerable variance, with a low target of $18.00 and a high of $45.00, resulting in a standard deviation of $8.724, reflecting differing market perspectives on its future performance.
- Investor Decision-Making: The stock's rise above the target price provides a signal for investors to reassess the company, weighing whether the current valuation is justified or if it is time to consider reducing their holdings in anticipation of potential market fluctuations.
See More
UroGen CMO Sells Shares Amid Strategic Developments
- Share Sale Details: Mark Schoenberg, CMO of UroGen Pharma, sold 10,000 shares on June 22, 2026, at an average price of $35.01 per share, totaling approximately $350,000, which reduced his direct holdings by 7.15% from 139,763 to 129,763 shares, indicating continued confidence in the company.
- Sales Growth: UroGen's Zusduri product saw a significant sales increase to $29.2 million in Q1 2026 from $15.8 million in Q4 2025, reflecting strong performance in the oncology market, while Jelmyto sales are projected to rise from $94 million in 2025 to between $97 million and $101 million, further solidifying market presence.
- Improving Losses: Although UroGen is still reporting losses, the Q1 2026 loss of $23.6 million represents a substantial decrease from $43.8 million in the same period last year, indicating improved financial health that may attract more investor interest.
- New Treatment Prospects: UroGen is developing UGN-103 as a new treatment option for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, featuring simpler manufacturing and reconstitution processes, which could provide better treatment solutions for patients and enhance the company's competitive edge in the market.
See More
UroGen Pharma CMO Sells Shares in Open Market Transaction
- Transaction Overview: UroGen Pharma's CMO Mark Schoenberg sold 10,000 shares for $350,100 on June 22, 2026, aligning with his typical trade size of around 9,000 shares, indicating a routine liquidity management strategy.
- Ownership Change Analysis: This sale reduced Schoenberg's direct holdings by 7.15%, yet he retains 129,763 shares, reflecting ongoing confidence in UroGen and a significant shareholder position.
- Sales Growth Momentum: UroGen's Jelmyto product is projected to increase sales from $94 million in 2025 to between $97 million and $101 million in 2026, while Zusduri's sales soared to $29.2 million in Q1 2026, up from $15.8 million in Q4 2025.
- Loss Reduction Trend: Although UroGen continues to report losses, the $23.6 million loss in Q1 2026 represents a significant decrease from $43.8 million in the same period last year, indicating positive progress in improving financial health.
See More
UroGen Pharma Executive Stock Transaction Overview
- Executive Stock Sale: UroGen Pharma's Chief Medical Officer Mark Schoenberg sold 5,222 ordinary shares for approximately $143,000, indicating a need for liquidity while reducing his direct holdings to 139,763 shares, suggesting continued confidence in the company's future.
- Options Exercise and Sale: Schoenberg exercised 10,000 options before immediately selling a portion of the shares to secure liquidity, reflecting his astute market awareness and financial management strategy.
- Market Performance and Risks: Despite UroGen Pharma's stock rising 168.23% over the past year, the recent settlement with Teva Pharmaceuticals for a non-exclusive license to sell generic Jelmyto may pose future competitive risks, prompting investors to proceed with caution.
- Sales Growth and Product Outlook: First-quarter sales of Jelmyto increased by 7% year-over-year to $21.7 million, accounting for 42.5% of total revenue, while another treatment, Zusduri, saw a significant 109% increase in sales to $29.2 million, showcasing the company's potential in navigating market competition.
See More
UroGen Pharma Executive Reduces Shareholding
- Share Reduction Transaction: Mark Schoenberg sold 5,222 ordinary shares on June 8, 2026, for approximately $143,000 at a weighted average price of $27.30 per share, reducing his direct holdings by 3.60% from 144,985 to 139,763 shares.
- Holding Proportion Change: Following this sale, Schoenberg's holdings are now approximately 62.5% of the September 2023 level, indicating a potential weakening of his direct investment intent in the company, which could affect market confidence in UroGen Pharma.
- Product Sales Performance: UroGen Pharma's Jelmyto saw a 7% year-over-year increase in first-quarter sales to $21.7 million, accounting for 42.5% of total revenue, but faces competition from Teva Pharmaceuticals' upcoming generic version, which may impact future revenues.
- Market Outlook Warning: Although UroGen Pharma's other drug, Zusduri, experienced a significant 109% year-over-year sales increase to $29.2 million in the first quarter, analysts advise caution for investors considering the stock, as it was not included in The Motley Fool Stock Advisor's list of top investment picks.
See More
