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Urogen Pharma - 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 files a lawsuit against Teva Pharmaceuticals for patent infringement related to JELMYTO® for urothelial cancer treatment.
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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.
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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.
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UroGen Pharma Ltd. (URGN) will report fourth quarter and full-year 2023 financial results on March 14, 2024. The company focuses on developing solutions for urothelial and specialty cancers. Investors can join the live webcast and conference call at 10:00 AM ET on the same day.
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UroGen Pharma Ltd. will present at TD Cowen’s 44th Annual Health Care Conference on March 4, 2024, at 1:30 PM ET. The presentation will focus on the company's innovative solutions for urothelial and specialty cancers. Investors can access the webcast on UroGen's website.
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UroGen Pharma Ltd. (URGN) will be presenting at the Guggenheim 6th Annual Biotechnology Conference and Oppenheimer 34th Annual Healthcare Life Sciences Conference in February 2024. The company aims to showcase its innovative solutions for treating urothelial and specialty cancers. The presentations will be available via webcast, and a replay will be accessible for approximately 90 days.
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UroGen Pharma Ltd. (URGN) has submitted the Chemistry, Manufacturing, and Controls (CMC) section of the New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution to the U.S. Food and Drug Administration (FDA). The submission marks a significant milestone for UroGen and aims to advance innovative therapies for individuals with low-grade, intermediate-risk non-muscle invasive bladder cancer. The rolling NDA for UGN-102 is expected to be completed in 2024, with a potential FDA decision as early as the first quarter of 2025.
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UroGen Pharma Ltd. (URGN) announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers. The agreement involves UGN-103, a formulation combining UroGen’s RTGel® technology with medac’s licensed mitomycin, which is expected to provide production, cost, supply, and product convenience advantages if approved. UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC. The strategic alliance aims to innovate non-surgical treatments for patients with urothelial cancers, including LG-IR-NMIBC. The intellectual property protection for this next-generation mitomycin formulation is expected to last until June 2035.
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UroGen Pharma Ltd. (Nasdaq: URGN) announced that Liz Barrett, President and CEO, will participate in a fireside chat at the upcoming B. Riley Virtual Healthcare Conference on January 18th at 12:00 p.m. ET. The event will be available for replay on UroGen's investor website for approximately 30 days.
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UroGen Pharma Ltd. (URGN) grants inducement restricted stock units to 17 new employees to support the commercial launch of Jelmyto® and the development of the company's pipeline.
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FAQ

What is the current stock price of Urogen Pharma (URGN)?

The current stock price of Urogen Pharma (URGN) is $10.08 as of February 21, 2025.

What is the market cap of Urogen Pharma (URGN)?

The market cap of Urogen Pharma (URGN) is approximately 452.0M.

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

Nasdaq:URGN

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451.96M
37.80M
9.18%
92.21%
14.2%
Biotechnology
Pharmaceutical Preparations
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United States
RA'ANANA