UroGen Pharma Ltd. (URGN) Stock News, Apr-Jun 2025

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.

UroGen Pharma (URGN) presented clinical trial data for UGN-102, their investigational intravesical treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at ASCO 2025. The presentations included 18-month duration of response data from the Phase 3 ENVISION trial, analysis of tumor burden impact from an ENVISION substudy, and complete response and duration of response data from both the ENVISION and ATLAS Phase 3 studies. The research focuses on evaluating UGN-102 (mitomycin) as a potential treatment option for bladder cancer patients.

UroGen Pharma (Nasdaq: URGN), a biotechnology company focused on developing treatments for urothelial and specialty cancers, has announced its participation in the TD Cowen 6th Annual Oncology Innovation Summit. The company will engage in a fireside chat on May 28, 2025, at 9:00 AM ET. The event, which focuses on insights for ASCO & EHA, will be held virtually. A webcast of the presentation will be available on UroGen's Investor Relations website, with replay access for approximately 90 days.

UroGen Pharma (NASDAQ: URGN) faced a setback as the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 4 to 5 against the favorable benefit/risk profile of UGN-102 (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The drug, currently under FDA review with a PDUFA date of June 13, 2025, aims to address an unmet medical need for elderly patients who often require repeated surgeries under general anesthesia. The Phase 3 ENVISION study demonstrated common side effects including dysuria, hematuria, and urinary tract infection. Despite the narrow negative vote, UroGen remains committed to working with the FDA during the review process, emphasizing that there are currently no FDA-approved therapies for this highly recurrent condition.

UroGen Pharma reported Q1 2025 financial results with JELMYTO net product sales reaching $20.3M, up 8% from Q1 2024, driven by 12% underlying demand growth. The company is approaching a crucial milestone with the FDA PDUFA date of June 13, 2025 for UGN-102, their lead pipeline product for bladder cancer treatment. An Oncologic Drugs Advisory Committee meeting is scheduled for May 21, 2025. Updated clinical data showed strong durability of response for UGN-102, with 80.6% probability of maintaining complete response at 18 months. The company ended Q1 with $200.4M in cash and equivalents. However, UroGen reported a net loss of $43.8M ($0.92 per share) compared to $32.3M loss in Q1 2024. For 2025, UroGen maintains JELMYTO revenue guidance of $94-98M and expects operating expenses of $215-225M.

UroGen (URGN) announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application for UGN-102, a treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA's PDUFA target action date is set for June 13, 2025.

The drug's Phase 3 ENVISION trial showed impressive results with a 79.6% complete response rate at 3 months after first instillation, and 82.5% duration of response at 12 months. Notably, UGN-102 is being developed for a condition that currently has no FDA-approved drugs.

UroGen Pharma (Nasdaq: URGN), a biotech company focused on developing treatments for urothelial and specialty cancers, has scheduled its first quarter 2025 financial results announcement for Monday, May 12, 2025. The company will release its results before market open, followed by a live audio webcast and conference call at 10:00 AM ET. 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 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.