Welcome to our dedicated page for Urogen Pharma news (Ticker: URGN), a resource for investors and traders seeking the latest updates and insights on Urogen Pharma stock.
UroGen Pharma Ltd. (URGN) is a biotechnology company whose news flow centers on therapies for urothelial and specialty cancers. Company announcements highlight the development and commercialization of RTGel®-based mitomycin formulations and other oncology candidates designed for non-surgical tumor ablation in the urinary tract.
On this page, readers can follow news about Jelmyto for low-grade upper tract urothelial cancer and ZUSDURI™ (mitomycin) for intravesical solution, described by UroGen as the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Updates often cover regulatory milestones such as U.S. Food and Drug Administration approvals, the assignment of a permanent HCPCS Level II J Code (J9282) for ZUSDURI, and coverage or reimbursement developments that affect access to treatment.
UroGen’s disclosures also include clinical trial results and pipeline progress, including data from the Phase 3 UTOPIA trial of UGN-103 for recurrent LG-IR-NMIBC, the clinical development program for ZUSDURI across studies such as OPTIMA II, ATLAS, and ENVISION, and ongoing work on next-generation candidates UGN-104 and UGN-501. Investors and healthcare professionals can track conference presentations, financial result releases, and corporate updates, such as inducement equity grants and proxy-related matters.
By reviewing the URGN news feed on Stock Titan, users can monitor how UroGen’s RTGel platform, approved products, and late-stage pipeline evolve over time, and how regulatory, clinical, and commercial developments may influence the company’s oncology portfolio.
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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.
UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, has announced its participation in an upcoming fireside chat at the TD Cowen 45th Annual Health Care Conference. The conference is scheduled for March 3-5, 2025.
The company will make webcasts of the conference presentations available on their Investor Relations website, with replays accessible for approximately 90 days following the event.
UroGen Pharma (NASDAQ: URGN) has expanded its oncology pipeline through the acquisition of ICVB-1042, a next-generation oncolytic virus, from IconOVir Bio. The acquisition involves issuing 374,843 ordinary shares (valued at approximately $4.0 million), a potential $15.0 million milestone payment upon achieving specific worldwide net sales targets, and a low single-digit percentage royalty on product sales.
ICVB-1042 is engineered to selectively destroy cancer cells while maintaining potency and triggering immune responses. This development represents a potential advancement over traditional BCG therapy in bladder cancer treatment. Additionally, UroGen announced multiple strategic research collaborations to explore their RTGel® technology's potential in enhancing immunotherapy effectiveness through improved dwell time.
UroGen Pharma (Nasdaq: URGN) announced results from subgroup analyses of the pivotal ENVISION trial evaluating UGN-102 for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study demonstrated strong complete response (CR) rates across different patient subgroups:
- 82.8% CR for patients with tumor burden ≤3 cm vs 73.2% for >3 cm
- 79.3% CR for patients with multiple tumors vs 82.9% for single tumors
The ENVISION trial included 240 patients, with 95% receiving all six weekly intravesical instillations. The overall CR rate was 79.6% at three months, with 82.3% probability of maintaining response after 12 months. UroGen completed its NDA submission to the FDA with a PDUFA date of June 13, 2025. A separate ATLAS trial analysis showed UGN-102 reduced risk of recurrence, progression or death by 54% compared to TURBT.