Urogen Pharma Stock Price, News & Analysis

UroGen Pharma (NASDAQ: URGN) announced Q2 2025 results and the launch of ZUSDURI™, marking its evolution into a multi-product uro-oncology company. JELMYTO® achieved net product sales of $24.2 million in Q2 2025, representing 11% year-over-year growth. The company reported a net loss of $49.9 million ($1.05 per share).

Key highlights include the FDA approval of ZUSDURI for recurrent LG-IR-NMIBC treatment, with a $5 billion+ market opportunity. The company maintains $161.6 million in cash and equivalents, and reaffirms 2025 JELMYTO revenue guidance of $94-98 million. Operating expenses are expected to be $215-225 million for 2025.

UroGen Pharma (NASDAQ: URGN) announced significant 24-month duration of response (DOR) data from its Phase 3 ENVISION trial for ZUSDURI™, the first FDA-approved treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The trial demonstrated a 72.2% DOR at 24 months (95% CI 64.1%, 78.8%) in patients who achieved complete response (CR) at three months. The initial CR rate at three months was 79.6%, with a median follow-up time of 23.7 months. Notably, the median DOR has not been reached, indicating sustained efficacy.

ZUSDURI represents a significant advancement over the current standard of care, which relies on repeated surgical procedures (TURBT). An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually. The most common adverse reactions were primarily mild to moderate, with serious adverse reactions occurring in 12% of patients.

UroGen Pharma (NASDAQ: URGN), a biotechnology company focused on urothelial and specialty cancer treatments, will release its Q2 2025 financial results on Thursday, August 7th, 2025, before market open.

The company will host a conference call and live audio webcast at 10:00 AM ET on the same day. Investors can access the webcast through UroGen's Investor Relations website, with a replay available for approximately 30 days after the event.

UroGen Pharma (Nasdaq: URGN) has published results from a Phase 3b study in Reviews in Urology, evaluating home administration of ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The study demonstrated that trained home health professionals can safely administer the treatment outside clinical settings.

Key findings include a 75% complete response rate at three months, with 6 out of 8 patients completing all scheduled treatments. The treatment involved weekly administration for six weeks, with the first dose given in clinic followed by five at-home instillations. 75% of completing patients would recommend the home-based approach to others.

UroGen Pharma (NASDAQ: URGN) has published promising five-year extension study results of their Phase 2b OPTIMA II trial for ZUSDURI™ (mitomycin) in treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The study demonstrated significant durability of response: Among 41 patients who achieved complete response (CR) at three months, the median duration of response was 24.2 months. For the 17 patients who entered long-term follow-up, the median duration of response reached 42.1 months. Notably, 94% of long-term follow-up patients were recurrent cases.

The most common adverse events included dysuria (41%), pollakiuria (21%), and hematuria (16%). ZUSDURI is specifically indicated for adults with recurrent LG-IR-NMIBC, offering a non-surgical treatment alternative in an outpatient setting.

UroGen Pharma (NASDAQ: URGN) has completed enrollment for its Phase 3 UTOPIA clinical trial of UGN-103, a next-generation treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The trial enrolled 99 patients across multiple global centers.

UGN-103 utilizes UroGen's proprietary RTGel® technology, enabling sustained drug release and prolonged bladder exposure. The treatment aims to improve upon ZUSDURI™ with a shorter manufacturing process and simplified reconstitution. The trial's primary endpoint is complete response rate at three months, with responding patients followed up to 12 months for durability assessment.

The company secured patent protection for UGN-103 through December 2041 following a Notice of Allowance from the U.S. Patent and Trademark Office in September 2024.

The FDA has approved UroGen Pharma's (URGN) ZUSDURI, making it the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The approval is based on the Phase 3 ENVISION trial results, which showed a 78% complete response rate at 3 months, with 79% of responders maintaining complete response at 12 months. ZUSDURI, utilizing UroGen's proprietary RTGel technology, offers an alternative to the current standard of care (TURBT surgery) for an estimated 59,000 U.S. patients annually. The treatment demonstrated a manageable safety profile with primarily mild to moderate side effects. Commercial launch is expected around July 1, 2025, with UroGen providing patient support programs for treatment access.

UroGen Pharma (URGN) has announced the grant of inducement restricted stock units (RSUs) to 27 new employees to support the commercialization of Jelmyto and pipeline development. The RSUs cover up to 118,000 ordinary shares and will vest equally over three years, with one-third vesting annually on the anniversary date. These grants, made under UroGen's 2019 Inducement Plan, serve as employment incentives in accordance with Nasdaq Rule 5635(c)(4). The new hires will focus on supporting Jelmyto, the company's first approved product for urothelial and specialty cancers, and advancing the company's development pipeline.

UroGen Pharma presented the design of their uTRACT Registry study at the 2025 ASCO Annual Meeting, focusing on real-world usage of JELMYTO in treating low-grade upper tract urothelial cancer (LG-UTUC). The registry has enrolled 274 participants across 22 clinical sites in the US, with a target of 400 patients, of which 340 are expected to have LG-UTUC. The three-year study will collect comprehensive data including patient history, treatment administration details, and key clinical outcomes such as disease status, duration of response, and safety metrics. The registry aims to establish best practices in LG-UTUC management and validate JELMYTO's clinical utility in real-world settings.