Urogen Pharma Stock Price, News & Analysis

UroGen Pharma (NASDAQ: URGN) has reported significant long-term follow-up data for JELMYTO®, its FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). The study, presented at the 2025 American Urological Association Annual Meeting, showed a median duration of response of 47.8 months among patients who achieved complete response after primary chemoablation.

The analysis included 41 patients from the OLYMPUS trial, with 21 having new-onset UTUC and 20 with recurrent UTUC. Both groups showed similar durability, with 8 patients in each experiencing recurrence or death not due to treatment. Twenty patients entered long-term follow-up with a median follow-up of 53.3 months.

The company is currently conducting the uTRACT Registry (NCT05874921) to gather real-world usage data, with 22 sites activated and 251 patients enrolled as of April 2025.

UroGen Pharma (URGN) reported updated results from its Phase 3 ENVISION trial of UGN-102, showing an 18-month duration of response (DOR) of 80.6% in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated that 79.6% of patients achieved complete response at three months.

The investigational treatment aims to provide an alternative to the current standard of care, which requires invasive surgical procedures (TURBT) under anesthesia. An estimated 59,000 patients with LG-IR-NMIBC face recurring surgeries annually. The FDA has accepted UroGen's New Drug Application for UGN-102 with a PDUFA date of June 13, 2025.

Common treatment-emergent adverse events were generally mild-to-moderate, including dysuria, hematuria, and urinary tract infection. The safety profile was consistent with previous UGN-102 studies.

UroGen Pharma (URGN) has announced promising safety data from its Phase 1 dose-escalation study of UGN-301 (zalifrelimab) for treating recurrent non-muscle invasive bladder cancer (NMIBC). The study, presented at the 2025 AUA Annual Meeting, showed the drug was well-tolerated across all dose levels with no dose-limiting toxicities.

The trial included up to 30 patients per arm, demonstrating that UGN-301's formulation in reverse thermal gel (RTGel®) allowed sustained bladder exposure with systemic exposure. Clinical activity showed 46% (6 of 13) of Ta/T1 disease patients and 33% (2 of 6) of CIS patients were recurrence-free or achieved complete response at week 12.

Notable long-term results included 60% (3 of 5) of Ta/T1 patients treated with 300mg remaining recurrence-free at 15 months. In the 500mg cohort, 25% (1 of 4) of CIS patients and 33% (1 of 3) of Ta/T1 patients remained disease-free at six months.

UroGen Pharma (NASDAQ: URGN) announced multiple data presentations at the upcoming American Urological Association (AUA) 2025 Annual Meeting in Las Vegas from April 26-29. The presentations will showcase key findings from their urothelial cancer treatment portfolio, including:

- 18-month duration of response data from the ENVISION trial for UGN-102

- Integrated patient-reported outcomes from UGN-102 studies (OPTIMA II, ATLAS, and ENVISION) in low-grade intermediate-risk non-muscle invasive bladder cancer

- Long-term outcomes from the OPTIMA II Phase 2B study of UGN-102

- Sub-analysis from OLYMPUS trial long-term follow-up study of JELMYTO

- Results from Phase 1 dose escalation study for UGN-301 (zalifrelimab)

Additionally, UroGen's CEO Liz Barrett will participate in the AUA Innovation Nexus Conference Showcase Panel discussion on April 25, focusing on urologic innovations and solutions.

UroGen Pharma (URGN) reported key financial results and clinical developments for Q4 and full year 2024. The company's flagship product JELMYTO achieved net product revenue of $90.4 million in 2024, up from $82.7 million in 2023, with 12% underlying demand growth.

A significant highlight is the updated 18-month Duration of Response (DOR) data from the Phase 3 ENVISION trial of UGN-102, showing an 80.6% response rate. The FDA is currently reviewing UGN-102's New Drug Application with a PDUFA date set for June 13, 2025. If approved, UGN-102 could address an estimated market opportunity exceeding $5 billion.

Financial position shows $241.7 million in cash and equivalents as of December 31, 2024. The company reported a net loss of $126.9 million ($2.96 per share) for 2024. For 2025, UroGen projects JELMYTO revenues between $94-98 million and operating expenses of $215-225 million.

UroGen Pharma (Nasdaq: URGN) has announced the issuance of inducement restricted stock units (RSUs) to 7 new employees. The RSUs, convertible into up to 18,500 ordinary shares, will vest equally over three years, with one-third vesting annually on the vesting date anniversary. These new hires will support the commercialization of Jelmyto® (mitomycin), the company's first approved product for pyelocalyceal solution, and aid in pipeline development. The grants were made under UroGen's 2019 Inducement Plan and comply with Nasdaq Listing Rule 5635(c)(4).

UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, has scheduled its fourth quarter and full-year 2024 financial results announcement for Monday, March 10, 2025, before market open.

The company will host a live audio webcast and conference call at 10:00 AM Eastern Time on the same day. Investors can access the webcast through UroGen's Investor Relations website, where a replay will be available for approximately 30 days following the presentation.