UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

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.

UroGen Pharma announces new data presentations at the American Urological Association 2024 Annual Meeting, highlighting clinical benefits of their portfolio for urothelial cancers. The company will present data on investigational drug UGN-102 and JELMYTO, showcasing potential advancements in treatment for patients with low-grade intermediate-risk non-muscle invasive bladder cancer and upper tract urothelial cancer.

UroGen's FDA acceptance of the Investigational New Drug Application for UGN-103, a next-generation mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer, brings potential advantages in manufacturing, reconstitution, and intellectual property protection until 2041.

UroGen Pharma files a lawsuit against Teva Pharmaceuticals for patent infringement related to JELMYTO® for urothelial cancer treatment.

UroGen Pharma Ltd. announced the initiation of an NDA submission to the FDA for UGN-102, with positive data from ENVISION trials. JELMYTO achieved $82.7 million in net product revenues in 2023. A new agreement with Pharmakon Advisors provides up to $100 million credit facility. Financial results showed growth in JELMYTO revenue but increased expenses.

UroGen Pharma Ltd. announces the grants of inducement restricted stock units to 12 new employees to support the commercialization of Jelmyto® and the development of their pipeline.