Urogen Pharma Stock Price, News & Analysis

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.

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.