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UroGen Pharma Ltd (NASDAQ: URGN) is a clinical-stage biopharmaceutical leader developing novel non-surgical therapies for urothelial cancers through its proprietary sustained release technology. This page serves as the definitive source for verified company announcements, clinical trial updates, and financial disclosures.
Access real-time updates on URGN's innovative hydrogel-based treatments, including regulatory milestones and research developments. Our curated news collection features:
• Clinical trial progress for localized cancer therapies
• FDA submission updates and regulatory interactions
• Financial performance reports and earnings calls
• Strategic partnerships in uro-oncology innovation
Bookmark this page for direct access to primary source materials and expert analysis of URGN's pioneering work in non-invasive cancer treatment solutions. Check regularly for the latest developments in sustained-release drug delivery systems and their impact on urothelial cancer care standards.
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.
UroGen Pharma (NASDAQ: URGN) has published results from a long-term follow-up study of JELMYTO® in The Journal of Urology. The study shows significant durability in treating low-grade upper tract urothelial cancer (LG-UTUC). Among the 41 patients who achieved complete response in the OLYMPUS trial, the median duration of response was 47.8 months (nearly four years), with a median follow-up of 28.1 months.
The study demonstrates JELMYTO's potential for sustained disease control and organ preservation in LG-UTUC patients. Currently, a real-world usage study called the JELMYTO uTRACT Registry is ongoing, with 228 patients enrolled across 21 sites as of January 2025.
UroGen Pharma (Nasdaq: URGN), a biotech company focused on urothelial and specialty cancer treatments, has announced its participation in two major investor conferences in February 2025.
The company will present at the Guggenheim Securities SMID Cap Biotech Conference on February 5, 2025, at 10:30 AM ET in New York, NY, featuring both a presentation and one-on-one investor meetings. Additionally, UroGen will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 1:20 PM ET in a virtual format.
Both conference presentations will be webcast and available on UroGen's Investor Relations website, with replays accessible for approximately 90 days following the events.
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