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 announced ENVISION study data, JELMYTO durability results, and financials for Q1 2024. JELMYTO net sales grew to $18.8 million, IND accepted for UGN-103, and UGN-102 NDA expected in Q3 2024. JELMYTO post-hoc analysis showed a median disease-free period of 47.8 months in LG-UTUC. UroGen also entered a licensing agreement for next-gen mitomycin-based UGN-103 to treat urothelial cancers.
UroGen Pharma (URGN) is set to participate in upcoming investor conferences like Citizens JMP Life Sciences Conference and H.C. Wainwright BioConnect Conference in May 2024. The company aims to present its innovative solutions for urothelial and specialty cancers, showcasing its commitment to developing and commercializing effective treatments.
UroGen Pharma has presented a real-world retrospective analysis at AUA 2024, reporting an 86% Recurrence-Free Survival (RFS) at 24 months with JELMYTO® for patients with low-grade Ta upper tract urothelial carcinoma who were complete responders to induction therapy. No differences in RFS were found based on treatment usage, tumor characteristics, or timing of administration. Patients who received maintenance therapy showed a 100% RFS at 24 months compared to 61% for those who did not receive maintenance therapy. These results suggest JELMYTO's potential in treating UTUC and improving long-term outcomes.
UroGen Pharma announced the results from the ATLAS trial, showing the durability of response in new and recurrent low-grade intermediate-risk non-muscle invasive bladder cancer patients treated with UGN-102. The data revealed high probabilities of remaining in complete response for both patient groups, indicating the potential of UGN-102 as a primary treatment option. The Phase 3 ATLAS study demonstrated favorable Disease Free Survival and Durability of Response rates with UGN-102 compared to the standard treatment. These findings highlight the promise of UGN-102 in transforming the landscape of LG-IR-NMIBC treatment, potentially reducing the need for repetitive surgeries and their associated risks and burdens.
UroGen Pharma highlights a real-world study on JELMYTO for low-grade upper tract urothelial cancer, showing a 60% complete response rate and lower stricture rate compared to the OLYMPUS pivotal trial. The study, presented at the American Urological Association Meeting 2024, demonstrates the safety and efficacy of retrograde administration of JELMYTO, with insights for positive outcomes. This sub-analysis involves 20 patients with promising results, indicating the potential of JELMYTO in the treatment of urothelial cancers.
UroGen Pharma, a biotech company focused on urothelial and specialty cancers, will release its 2024 first-quarter financial results on May 13, 2024. A conference call and webcast are scheduled for the same day at 10:00 AM ET.
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