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UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

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

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.

News

UroGen Pharma to Report Third Quarter 2023 Financial Results on Tuesday, November 14, 2023

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UroGen Pharma Ltd. (Nasdaq: URGN) will report third quarter 2023 financial results on November 14, 2023, at 8:00 AM EDT, followed by a live audio webcast and conference call at 10:00 AM Eastern Time.
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Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024

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UroGen Pharma has reached an agreement with the FDA for the submission of a New Drug Application for UGN-102, a potential non-surgical treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. The FDA agreed to a rolling review and early submission of the Chemistry, Manufacturing and Controls sections of the NDA. Positive Phase 3 results from previous studies support the development of UGN-102.
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UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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UroGen Pharma grants restricted stock units and options to new employees to support the commercial launch of Jelmyto and pipeline development.
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UroGen Pharma to Present at Upcoming Investor Conferences

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UroGen Pharma to present at investor conferences in September
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UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

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UroGen Pharma announced positive results from the ENVISION and ATLAS Phase 3 trials of UGN-102 in treating bladder cancer. They reported record net product revenues of $21.1 million in Q2 2023, a 27% increase from the same period last year. The company also completed a $120 million private placement of ordinary shares and pre-funded warrants.
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The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

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UroGen Pharma Ltd. (Nasdaq: URGN) announced that the Phase 3 ATLAS clinical trial for investigational agent UGN-102 demonstrated superiority to TURBT with a 55% reduction of risk for recurrence, progression, or death in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial showed a tumor-free complete response rate of 65% for patients who received UGN-102, compared to 64% for patients who underwent TURBT. The Phase 3 ENVISION trial also produced positive results, with a 79.2% rate of complete response at 3 months following the initial treatment. The estimated probability of remaining event free 15 months after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT monotherapy. UroGen is hopeful that these findings could lead to a potential non-surgical therapeutic alternative for patients and doctors eager for additional options.
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UroGen Pharma to Report Second Quarter 2023 Financial Results on Thursday, August 10, 2023

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UroGen Pharma Ltd. (Nasdaq: URGN) will report second quarter 2023 financial results on Thursday, August 10, 2023, followed by a live audio webcast and conference call at 10:00 AM Eastern Time.
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UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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UroGen Announces $120 Million Private Placement of Ordinary Shares

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UroGen Pharma Ltd. (URGN) announces a definitive securities purchase agreement for a private placement, led by RA Capital Management L.P. and Great Point Partners LLC, with gross proceeds of approximately $120 million. The company intends to use the net proceeds for non-clinical and clinical development activities, commercialization expenses, and general corporate purposes.
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UGN-102, in Development as the Potential First Non-Surgical Therapy for LG-IR-NMIBC, Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials

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UroGen Pharma announces positive topline data from Phase 3 trials of UGN-102 for bladder cancer treatment
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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 $11.94 as of November 4, 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 510.0M.

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.

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UroGen Pharma Ltd. Ordinary Shares

Nasdaq:URGN

URGN Rankings

#3076 Ranked by Market Cap
N/A Ranked by Dividends

URGN Stock Data

510.00M
42.11M
9.2%
93.72%
15.41%
Biotechnology
Pharmaceutical Preparations
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United States of America
RA'ANANA