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UroGen Pharma Ltd. (Nasdaq: URGN) is a clinical-stage biopharmaceutical company dedicated to developing innovative non-surgical treatments for urological conditions, particularly uro-oncology. The company is headquartered in Ra’anana, Israel, with its U.S. headquarters in New York.
UroGen’s core technology, RTGel™, is a proprietary sustained-release, hydrogel-based platform designed to improve drug delivery and efficacy. By prolonging the exposure of the urinary tract tissue to medications, RTGel™ aims to make local therapies more effective. This innovative approach addresses significant unmet needs in the field of urology.
The company’s lead product candidates include Mitogel™ (mitomycin urothelial gel) and Vesigel™ (mitomycin intravesical gel). Both products target non-surgical tumor ablation in non-muscle invasive urothelial cancers. Mitogel™ is specifically designed to treat low-grade upper tract urothelial carcinoma, while Vesigel™ aims to treat bladder cancer.
Additionally, UroGen's commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, has shown promise in treating patients. Their investigational candidate, UGN-102 (mitomycin) for intravesical solution, is in development for bladder cancer treatment.
UroGen is also advancing its immuno-uro-oncology pipeline with UGN-301 (zalifrelimab), an anti-CTLA-4 antibody, which is being explored for both monotherapy and combination therapy.
Through strategic partnerships, cutting-edge research, and a commitment to addressing complex medical challenges, UroGen Pharma continues to push the boundaries in the treatment of urothelial diseases.
UroGen Pharma (NASDAQ: URGN) has appointed David Lin as the new Chief Commercial Officer. Lin, who boasts extensive experience from Bristol Myers Squibb and other significant roles in the pharmaceutical industry, will lead UroGen's commercial strategy. His key responsibilities include preparing for the potential launch of UGN-102 and enhancing the commercialization of JELMYTO® (mitomycin). Lin's background includes successful launches of CAR T therapies and global expansion initiatives. Jeff Bova, the former CCO, will step down on June 3 to pursue new opportunities.
UroGen Pharma (Nasdaq: URGN), a biotech firm focused on urothelial and specialty cancers, will participate in a virtual fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit. The event is scheduled for May 28, 2024, at 3:20 PM ET. Investors can access a live webcast through the company's website. This event presents an opportunity for UroGen to discuss its innovative cancer treatments and engage with stakeholders.
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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