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UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

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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.

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UroGen Pharma announced that its Phase 3 ENVISION trial for UGN-102, targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), achieved an 82.3% duration of response (DOR) at 12 months. The trial showed a complete response (CR) rate of 79.6% at three months. The Kaplan-Meier estimates for DOR at 15 and 18 months were both 80.9%. The safety profile was consistent with previous trials, with common side effects including dysuria, hematuria, and urinary tract infection. UroGen has initiated a New Drug Application (NDA) to the FDA, aiming for a decision by Q1 2025. A virtual event discussing these results is scheduled for today at 11:00 AM ET.

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UroGen Pharma (Nasdaq: URGN) has announced the grant of inducement restricted stock units (RSUs) and an option to 15 new employees, including Chief Commercial Officer David Lin. Up to 52,500 shares will be issued upon vesting for 14 employees, and up to 13,041 shares plus 71,942 shares upon the exercise of an option will be issued for Lin. RSUs and options vest over three years, contingent on continued employment. The exercise price for the option is set at $13.13, the closing price on June 3, 2024. These grants are under UroGen's 2019 Inducement Plan, following Nasdaq Listing Rule 5635(c)(4), to support the commercialization of Jelmyto and pipeline development.

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UroGen Pharma (Nasdaq: URGN) will host a virtual event on June 13, 2024, at 11:00 a.m. ET, to present the 12-month durability response results from its Phase 3 ENVISION trial. This trial assesses UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The focus will be on patients who showed a complete response at three months after six weekly doses. The event will include insights from Key Opinion Leaders and a panel discussion. A replay will be available on the company's website after the event.

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UroGen Pharma (Nasdaq: URGN) announced its participation in the 45th Annual Goldman Sachs Global Healthcare Conference. The event will occur in Miami, FL, from June 10-13, 2024, and UroGen's management will present on June 11 at 3:20 PM ET. The presentation will be in a fireside chat format. A webcast will be available live and for replay for approximately 90 days on the company's investor relations website.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of UroGen Pharma Ltd. Ordinary Shares (URGN)?

The current stock price of UroGen Pharma Ltd. Ordinary Shares (URGN) is $10.64 as of December 20, 2024.

What is the market cap of UroGen Pharma Ltd. Ordinary Shares (URGN)?

The market cap of UroGen Pharma Ltd. Ordinary Shares (URGN) is approximately 449.0M.

What is UroGen Pharma Ltd. (URGN)?

UroGen Pharma Ltd. is a clinical-stage biopharmaceutical company focused on developing innovative non-surgical treatments for urology, particularly uro-oncology.

What is RTGel™?

RTGel™ is UroGen’s proprietary sustained-release, hydrogel-based platform technology designed to improve the therapeutic profiles of existing drugs by enabling prolonged exposure to urinary tract tissues.

What are UroGen’s lead product candidates?

UroGen’s lead product candidates include Mitogel™ (mitomycin urothelial gel) and Vesigel™ (mitomycin intravesical gel), both aimed at non-surgical tumor ablation in non-muscle invasive urothelial cancers.

Where is UroGen Pharma headquartered?

UroGen Pharma is headquartered in Ra’anana, Israel, with U.S. headquarters in New York.

What is Jelmyto?

Jelmyto (mitomycin) for pyelocalyceal solution is a commercial product developed by UroGen for treating certain urothelial cancers.

What is UGN-102?

UGN-102 (mitomycin) for intravesical solution is an investigational candidate by UroGen Pharma aimed at treating bladder cancer.

What is UroGen’s UGN-301?

UGN-301 (zalifrelimab) is an anti-CTLA-4 antibody being developed for both monotherapy and combination therapy in UroGen’s immuno-uro-oncology pipeline.

What types of cancer is UroGen Pharma focusing on?

UroGen Pharma focuses on non-muscle invasive urothelial cancers, including low-grade upper tract urothelial carcinoma and bladder cancer.

How does UroGen Pharma generate revenue?

UroGen Pharma generates revenue primarily through product sales.

What is the mission of UroGen Pharma?

The mission of UroGen Pharma is to develop advanced non-surgical treatments that address unmet needs in the field of urology, particularly uro-oncology.

UroGen Pharma Ltd. Ordinary Shares

Nasdaq:URGN

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449.00M
37.83M
9.18%
92.27%
15.27%
Biotechnology
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RA'ANANA