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UroGen Pharma Ltd - URGN STOCK NEWS

Welcome to our dedicated news page for UroGen Pharma (Ticker: URGN), a resource for investors and traders seeking the latest updates and insights on UroGen Pharma.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect UroGen Pharma's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of UroGen Pharma's position in the market.

News
UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers
Rhea-AI Summary
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.
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UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Rhea-AI Summary
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.
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UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals
Rhea-AI Summary
UroGen Pharma files a lawsuit against Teva Pharmaceuticals for patent infringement related to JELMYTO® for urothelial cancer treatment.
Rhea-AI Impact
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-3.05%
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UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102
Rhea-AI Summary
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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End-of-Day
-17.97%
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UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Rhea-AI Summary
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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-0.22%
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UroGen Pharma to Report Fourth Quarter and Full-Year 2023 Financial Results on Thursday, March 14, 2024
Rhea-AI Summary
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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3.66%
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UroGen Pharma to Present at TD Cowen 44th Annual Health Care Conference
Rhea-AI Summary
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.
Rhea-AI Impact
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5.09%
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UroGen Pharma to Participate at Upcoming Investor Conferences
Rhea-AI Summary
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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1.27%
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UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102
Rhea-AI Summary
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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-0.46%
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UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers
Rhea-AI Summary
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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Rhea-AI Sentiment
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6.27%
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Stock URGN logo
UroGen Pharma Ltd

Nasdaq:URGN

URGN Rankings

#3000 Ranked by Market Cap
#2431 Ranked by Stock Gains
N/A Ranked by Dividends

URGN Stock Data

515.24M
24.37M
11.35%
70.5%
12.27%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
Israel
9 Hataasiya St

About URGN

urogen pharma ltd. (nasdaq:urgn) is a clinical-stage biopharmaceutical company developing advanced non-surgical treatments to address unmet needs in the field of urology, with a focus on uro-oncology. the company has developed rtgel™, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. urogen pharma's sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. urogen pharma's lead product candidates, mitogel™ (mitomycin urothelial gel) and vesigel™ (mitomycin intravesical gel), are designed to potentially remove tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial carcinoma and bladder cancer, respectively. urogen pharma is headquartered in ra’anana, israel with u.s. headquarters in new york.