We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Here's Why You Should Add URGN Stock to Your Portfolio Now
Read MoreHide Full Article
Key Takeaways
UroGen's Zusduri revenues surged 73% sequentially to $50.4 million in the second quarter of 2026.
Jelmyto generated $22.0 million in the second quarter, with 2026 revenue guidance of $97-$101 million.
UGN-103 showed a 94.5% six-month response rate, with an NDA submitted in August 2026.
UroGen Pharma (URGN - Free Report) is emerging as a commercial-stage biotech with an expanding presence in uro-oncology. The company has two marketed products, Zusduri and Jelmyto, and a pipeline that could support additional growth in bladder cancer and other urothelial cancers.
The investment thesis for UroGen is increasingly shifting from a development-stage biotech story to a commercial growth story backed by multiple potential products. Strong Zusduri uptake, continued Jelmyto sales and progress across pipeline candidates, including UGN-103, UGN-104 and UGN-501, provide several potential growth drivers.
Year to date, shares of UroGen have surged 72.7% compared with the industry’s 8.9% growth.
Image Source: Zacks Investment Research
Zusduri: URGN’s Strong Commercial Growth Driver
Zusduri is UroGen’s key growth driver and a major commercial opportunity. The FDA approved the drug in June 2025 for adults with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The mitomycin-based treatment uses UroGen's proprietary RTGel technology to keep the drug in contact with bladder tumors longer and offers an alternative to surgical tumor removal in recurrent LG-IR-NMIBC. Its adoption has accelerated since the permanent J-Code took effect in January 2026, supporting easier reimbursement.
The drug generated $50.4 million in product revenues in the second quarter of 2026, up 73% sequentially. UroGen believes Zusduri has the potential to become a greater-than-$1 billion peak-sales product, based on its assumptions regarding market size, pricing and market penetration.
Jelmyto Provides a Stable Revenue Base for URGN
UroGen does not rely solely on Zusduri. Its first commercial product, Jelmyto, provides an established source of revenues while Zusduri grows. Approved for adults with low-grade upper tract urothelial cancer (LG-UTUC), Jelmyto generated $22.0 million in the second quarter of 2026, with 2026 full-year revenue guidance of $97-$101 million. The company’s settlement with Teva Pharmaceutical (TEVA - Free Report) also provides several years of additional commercial visibility, as Teva can launch a generic version of Jelmyto only from Sept. 15, 2030, subject to FDA approval and other conditions.
UGN-103 Could Extend UroGen’s Bladder Cancer Opportunity
UGN-103 is a next-generation mitomycin formulation that could build on Zusduri’s commercial success in recurrent LG-IR-NMIBC. In the phase III UTOPIA study, it achieved a 94.5% six-month duration-of-response rate compared with 91.9% for Zusduri in the pivotal ENVISION study. UroGen submitted the new drug application for UGN-103 in August 2026, with a potential launch in 2027 if approved. Its simpler manufacturing and reconstitution process, along with expansion into additional NMIBC settings, could make UGN-103 another important growth driver for UroGen.
The company plans to investigate additional uses in high-risk NMIBC and as an adjuvant treatment for intermediate-risk NMIBC.
UroGen has intellectual property protection supporting its commercial strategy. In July 2026, the company announced a new U.S. patent allowance that expected to provide protection for Zusduri and UGN-103 through July 2044.
Other Pipeline Assets on the Move
UroGen is advancing UGN-104 for low-grade upper tract urothelial cancer, with its phase III study expected to complete enrollment by the end of this year. The company is also developing UGN-501, a next-generation oncolytic virus for non-muscle-invasive bladder cancer. The FDA cleared its investigational new drug application in July 2026, with phase I enrollment expected to begin in the fourth quarter.
In August 2026, UroGen expanded its technology platform through a strategic collaboration with IntraGel. The deal gives UroGen a research license and exclusive options to develop up to three oncology products using IntraGel’s sustained-release gel technology. UroGen also received an option to acquire worldwide rights to TumoCure, an investigational treatment for advanced head and neck cancer. The deal could help UroGen diversify its pipeline beyond urothelial cancers.
Over the past 60 days, estimates for UroGen’s 2026 bottom line have improved from a loss of 76 cents to 20 cents per share. Over the same period, earnings estimates for 2027 have risen from $1.62 to $3.49 per share.
Other Stocks to Consider
Some other top-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) and AC Immune (ACIU - Free Report) , currently sporting a Zacks Rank #1 each.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 92.6% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 17.2% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
Image: Bigstock
Here's Why You Should Add URGN Stock to Your Portfolio Now
Key Takeaways
UroGen Pharma (URGN - Free Report) is emerging as a commercial-stage biotech with an expanding presence in uro-oncology. The company has two marketed products, Zusduri and Jelmyto, and a pipeline that could support additional growth in bladder cancer and other urothelial cancers.
The investment thesis for UroGen is increasingly shifting from a development-stage biotech story to a commercial growth story backed by multiple potential products. Strong Zusduri uptake, continued Jelmyto sales and progress across pipeline candidates, including UGN-103, UGN-104 and UGN-501, provide several potential growth drivers.
Year to date, shares of UroGen have surged 72.7% compared with the industry’s 8.9% growth.
Image Source: Zacks Investment Research
Zusduri: URGN’s Strong Commercial Growth Driver
Zusduri is UroGen’s key growth driver and a major commercial opportunity. The FDA approved the drug in June 2025 for adults with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The mitomycin-based treatment uses UroGen's proprietary RTGel technology to keep the drug in contact with bladder tumors longer and offers an alternative to surgical tumor removal in recurrent LG-IR-NMIBC. Its adoption has accelerated since the permanent J-Code took effect in January 2026, supporting easier reimbursement.
The drug generated $50.4 million in product revenues in the second quarter of 2026, up 73% sequentially. UroGen believes Zusduri has the potential to become a greater-than-$1 billion peak-sales product, based on its assumptions regarding market size, pricing and market penetration.
Jelmyto Provides a Stable Revenue Base for URGN
UroGen does not rely solely on Zusduri. Its first commercial product, Jelmyto, provides an established source of revenues while Zusduri grows. Approved for adults with low-grade upper tract urothelial cancer (LG-UTUC), Jelmyto generated $22.0 million in the second quarter of 2026, with 2026 full-year revenue guidance of $97-$101 million. The company’s settlement with Teva Pharmaceutical (TEVA - Free Report) also provides several years of additional commercial visibility, as Teva can launch a generic version of Jelmyto only from Sept. 15, 2030, subject to FDA approval and other conditions.
UGN-103 Could Extend UroGen’s Bladder Cancer Opportunity
UGN-103 is a next-generation mitomycin formulation that could build on Zusduri’s commercial success in recurrent LG-IR-NMIBC. In the phase III UTOPIA study, it achieved a 94.5% six-month duration-of-response rate compared with 91.9% for Zusduri in the pivotal ENVISION study. UroGen submitted the new drug application for UGN-103 in August 2026, with a potential launch in 2027 if approved. Its simpler manufacturing and reconstitution process, along with expansion into additional NMIBC settings, could make UGN-103 another important growth driver for UroGen.
The company plans to investigate additional uses in high-risk NMIBC and as an adjuvant treatment for intermediate-risk NMIBC.
UroGen has intellectual property protection supporting its commercial strategy. In July 2026, the company announced a new U.S. patent allowance that expected to provide protection for Zusduri and UGN-103 through July 2044.
Other Pipeline Assets on the Move
UroGen is advancing UGN-104 for low-grade upper tract urothelial cancer, with its phase III study expected to complete enrollment by the end of this year. The company is also developing UGN-501, a next-generation oncolytic virus for non-muscle-invasive bladder cancer. The FDA cleared its investigational new drug application in July 2026, with phase I enrollment expected to begin in the fourth quarter.
In August 2026, UroGen expanded its technology platform through a strategic collaboration with IntraGel. The deal gives UroGen a research license and exclusive options to develop up to three oncology products using IntraGel’s sustained-release gel technology. UroGen also received an option to acquire worldwide rights to TumoCure, an investigational treatment for advanced head and neck cancer. The deal could help UroGen diversify its pipeline beyond urothelial cancers.
Urogen Pharma Price and Consensus
Urogen Pharma price-consensus-chart | Urogen Pharma Quote
URGN’s Zacks Rank & Estimates
UroGen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for UroGen’s 2026 bottom line have improved from a loss of 76 cents to 20 cents per share. Over the same period, earnings estimates for 2027 have risen from $1.62 to $3.49 per share.
Other Stocks to Consider
Some other top-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) and AC Immune (ACIU - Free Report) , currently sporting a Zacks Rank #1 each.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 92.6% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 17.2% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.