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.
UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in two healthcare conferences in September: the H.C. Wainwright & Co. Annual Global Investment Conference on September 13 and the Ladenburg Thalmann Healthcare Conference on September 29. Both presentations will be accessible via webcasts on UroGen’s website, where replays will be available for 30 days. UroGen focuses on innovative treatments for urothelial and specialty cancers, leveraging proprietary technologies like RTGel™ for local therapies that enhance drug effectiveness.
UroGen Pharma reported second quarter 2022 net product revenue from Jelmyto of $16.6 million, marking a 22% increase from Q1 2022 and a 28% increase year-over-year.
The company reaffirmed its 2022 revenue guidance, expecting $70-$80 million in total. Clinical trials for UGN-102 are on track, with enrollment expected to complete by year-end 2022. The company is targeting cash flow break-even by 2025. However, a net loss of $26.7 million was reported for the quarter, while cash equivalents totaled $112.4 million as of June 30, 2022.
UroGen Pharma Ltd. (Nasdaq: URGN) will announce its Q2 2022 financial results on
UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) and options to 16 new employees as part of their ongoing commercial launch of Jelmyto® and pipeline development. A total of 53,000 shares will be available through RSUs, while 12,000 shares are associated with options, both vesting over three years. These grants comply with Nasdaq rules, aimed at incentivizing new talent to enhance UroGen's capabilities in treating urothelial and specialty cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announces participation in two healthcare conferences: the H.C. Wainwright & Co. Global Investment Conference on May 25 at 11:00 a.m. ET and the Jefferies Healthcare Conference on June 9 at 1:00 p.m. ET. Webcasts for both events will be accessible on UroGen's website, with replays available for 30 days. UroGen focuses on developing innovative solutions for urothelial and specialty cancers, utilizing its proprietary RTGel™ technology for improved treatment options.
UroGen Pharma Ltd. (Nasdaq: URGN) presented new data at the 2022 American Urological Association annual meeting in New Orleans. The study highlights the effectiveness of the antegrade approach via nephrostomy tube for administering JELMYTO (mitomycin) in treating low-grade upper tract urothelial cancer. This method showed promising safety and efficacy data, demonstrating a complete response in 50% of patients. Although the study was retrospective and limited in size, it adds valuable real-world evidence to support treatment options for patients.
UroGen Pharma Ltd. (Nasdaq: URGN) will showcase data on JELMYTO® (mitomycin) for treating low-grade upper tract urothelial cancer at the 2022 AUA Annual Meeting in New Orleans, scheduled from May 13-16. Significant presentations will include findings from the Phase 2b OPTIMA II trial highlighting health-related quality of life impacts. JELMYTO is noted for being the only non-surgical treatment option. The presentations will be published in the June 2022 issue of The Journal of Urology.
UroGen Pharma Ltd. (URGN) reported a significant 81% increase in net product revenue for Jelmyto, reaching $13.6 million in Q1 2022 compared to Q1 2021. The company is advancing its clinical pipeline, with enrollment in the Phase 3 ENVISION trial for UGN-102 nearing completion by year-end 2022. Additionally, a new multi-arm Phase 1 trial for UGN-301 has been initiated. Despite revenue growth, UroGen reported a net loss of $28.4 million, up from $25.9 million in the same quarter last year. Expected full-year 2022 revenues are projected between $70 million and $80 million.
UroGen Pharma Ltd. (Nasdaq: URGN) is set to report its first quarter 2022 financial results on May 10, 2022, before market opening. Following the announcement, there will be a live audio webcast and conference call at 10:00 AM ET. UroGen is focused on developing innovative treatments for urothelial and specialty cancers, leveraging its proprietary RTGel™ technology for sustained drug release. The company aims to enhance local therapy effectiveness in bladder cancer treatments with its products, including Jelmyto® and investigational UGN-102.
UroGen Pharma Ltd. announced FDA clearance for its IND application to start a Phase 1 clinical study of the anti-CTLA-4 immunotherapy UGN-301 (zalifrelimab) for recurrent non-muscle invasive bladder cancer (NMIBC). The multi-arm study aims to determine the safety and recommended Phase 2 dose of monotherapy and combination therapy. UroGen plans to utilize its proprietary RTGel™ technology for intravesical delivery, targeting high-grade NMIBC. The study is expected to commence in April, enhancing treatment options for patients with limited responses to existing therapies.