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: 31.950
Low
31.00
Averages
40.25
High
55.00
Current: 31.950
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.
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
UroGen Pharma Settles Patent Dispute with Teva Pharmaceuticals
- Patent Dispute Resolution: UroGen Pharma has reached a settlement with Teva Pharmaceuticals to resolve a patent dispute over its cancer therapy Jelmyto, ensuring UroGen's market exclusivity in the U.S. until April 15, 2027.
- Market Access Arrangement: As part of the settlement, Teva will receive a non-exclusive license to market its generic version starting September 15, 2030, pending FDA approval, which will provide Teva with a new revenue stream.
- Litigation Dismissal: The parties will request the court to dismiss the litigation with prejudice, meaning similar claims cannot be refiled, thereby reducing future legal risks and uncertainties.
- Market Impact Assessment: This settlement not only protects UroGen's market share but may also influence Teva's branding strategy, marking a further expansion into the generic drug market and enhancing its competitiveness in cancer treatment.
See More
Superstring Capital Reduces Stake in UroGen Pharma
- Stake Reduction Details: Superstring Capital reduced its stake in UroGen Pharma by 330,983 shares in Q1 2026, with an estimated transaction value of $6.64 million, indicating ongoing confidence despite the holding dropping to 4.98% of AUM.
- Market Performance Analysis: UroGen Pharma's stock has surged over 600% in the past year, currently priced at $28.89, significantly outperforming the S&P 500's 28% increase, showcasing its strong position in the biotech sector.
- Clinical Progress Highlights: UroGen recently reported that its newly approved bladder cancer therapy ZUSDURI achieved a 64.5% probability of remaining disease-free at three years, while UGN-103's Phase 3 trial showed a 94.5% six-month duration of response, underscoring the clinical potential of its product pipeline.
- Long-term Investment Outlook: Despite the stake reduction, UroGen remains one of Superstring's top five holdings, and the key question for investors will be whether UroGen can convert its clinical momentum into a sustainable oncology franchise, especially with UGN-103's patent protection expected to last until 2041.
See More
Superstring Capital Reduces Stake in UroGen Pharma
- Stake Reduction Details: Superstring Capital sold 330,983 shares of UroGen Pharma in Q1, with an estimated transaction value of $6.64 million, indicating a potential decrease in confidence in the company.
- Position Value Decline: The quarter-end value of Superstring's holdings in UroGen fell by $9.86 million, reflecting the dual impact of trading activity and stock price fluctuations, with total holdings now at 387,371 shares valued at $6.96 million.
- Company Strategy and Market Position: UroGen Pharma focuses on innovative therapies, particularly for non-muscle invasive bladder cancer, and despite the stake reduction, it remains one of Superstring's top five holdings, accounting for about 5%, highlighting its significance in the rapidly growing biotech market.
- Clinical Progress and Investor Interest: UroGen's recently approved bladder cancer therapy ZUSDURI demonstrated a 64.5% probability of three-year disease-free survival, and promising Phase 3 data for UGN-103 is on track for NDA submission in Q3 2026, prompting investors to consider whether the company can leverage clinical momentum into a sustainable oncology franchise.
See More
Healthcare Stocks Rise 0.8% on NYSE Healthcare Index
- Healthcare Sector Recovery: On Wednesday afternoon, the NYSE Healthcare Index rose by 0.8%, indicating a gradual restoration of investor confidence in the healthcare sector, likely driven by an overall improvement in market sentiment.
- Market Rebound Signs: The increase in healthcare stocks suggests that despite economic uncertainties, investors remain optimistic about the long-term growth potential of the healthcare industry, particularly in areas like drug development and medical technology innovation.
- Increased Investor Attention: As the healthcare sector continues to evolve, heightened investor interest may lead to increased capital inflows into this area, further driving stock prices upward.
- Optimistic Industry Outlook: The growth potential of the healthcare sector is attracting more investor attention, especially against the backdrop of rising global health demands, with expectations for increased investments to support innovation and expansion in the future.
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
UroGen Pharma Settles Patent Dispute with Teva Pharmaceuticals
- Patent Dispute Resolution: UroGen Pharma has reached a settlement with Teva Pharmaceuticals to resolve a patent dispute over its cancer therapy Jelmyto, ensuring UroGen's market exclusivity in the U.S. until April 15, 2027.
- Market Access Arrangement: As part of the settlement, Teva will receive a non-exclusive license to market its generic version starting September 15, 2030, pending FDA approval, which will provide Teva with a new revenue stream.
- Litigation Dismissal: The parties will request the court to dismiss the litigation with prejudice, meaning similar claims cannot be refiled, thereby reducing future legal risks and uncertainties.
- Market Impact Assessment: This settlement not only protects UroGen's market share but may also influence Teva's branding strategy, marking a further expansion into the generic drug market and enhancing its competitiveness in cancer treatment.
See More
Superstring Capital Reduces Stake in UroGen Pharma
- Stake Reduction Details: Superstring Capital reduced its stake in UroGen Pharma by 330,983 shares in Q1 2026, with an estimated transaction value of $6.64 million, indicating ongoing confidence despite the holding dropping to 4.98% of AUM.
- Market Performance Analysis: UroGen Pharma's stock has surged over 600% in the past year, currently priced at $28.89, significantly outperforming the S&P 500's 28% increase, showcasing its strong position in the biotech sector.
- Clinical Progress Highlights: UroGen recently reported that its newly approved bladder cancer therapy ZUSDURI achieved a 64.5% probability of remaining disease-free at three years, while UGN-103's Phase 3 trial showed a 94.5% six-month duration of response, underscoring the clinical potential of its product pipeline.
- Long-term Investment Outlook: Despite the stake reduction, UroGen remains one of Superstring's top five holdings, and the key question for investors will be whether UroGen can convert its clinical momentum into a sustainable oncology franchise, especially with UGN-103's patent protection expected to last until 2041.
See More
Superstring Capital Reduces Stake in UroGen Pharma
- Stake Reduction Details: Superstring Capital sold 330,983 shares of UroGen Pharma in Q1, with an estimated transaction value of $6.64 million, indicating a potential decrease in confidence in the company.
- Position Value Decline: The quarter-end value of Superstring's holdings in UroGen fell by $9.86 million, reflecting the dual impact of trading activity and stock price fluctuations, with total holdings now at 387,371 shares valued at $6.96 million.
- Company Strategy and Market Position: UroGen Pharma focuses on innovative therapies, particularly for non-muscle invasive bladder cancer, and despite the stake reduction, it remains one of Superstring's top five holdings, accounting for about 5%, highlighting its significance in the rapidly growing biotech market.
- Clinical Progress and Investor Interest: UroGen's recently approved bladder cancer therapy ZUSDURI demonstrated a 64.5% probability of three-year disease-free survival, and promising Phase 3 data for UGN-103 is on track for NDA submission in Q3 2026, prompting investors to consider whether the company can leverage clinical momentum into a sustainable oncology franchise.
See More
Healthcare Stocks Rise 0.8% on NYSE Healthcare Index
- Healthcare Sector Recovery: On Wednesday afternoon, the NYSE Healthcare Index rose by 0.8%, indicating a gradual restoration of investor confidence in the healthcare sector, likely driven by an overall improvement in market sentiment.
- Market Rebound Signs: The increase in healthcare stocks suggests that despite economic uncertainties, investors remain optimistic about the long-term growth potential of the healthcare industry, particularly in areas like drug development and medical technology innovation.
- Increased Investor Attention: As the healthcare sector continues to evolve, heightened investor interest may lead to increased capital inflows into this area, further driving stock prices upward.
- Optimistic Industry Outlook: The growth potential of the healthcare sector is attracting more investor attention, especially against the backdrop of rising global health demands, with expectations for increased investments to support innovation and expansion in the future.
See More
