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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 Initiates Submission of a Rolling NDA to the FDA for UGN-102

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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 Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers

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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 to Participate in the B. Riley Healthcare Conference

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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 Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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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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UroGen Pharma Reports Third Quarter 2023 Financial Results

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UroGen Pharma Ltd. (Nasdaq: URGN) reported a strong growth with JELMYTO® net product revenues of $20.9 million in Q3 2023, an increase of ~30% from the same period last year. The company also announced an agreement with the FDA to proceed with rolling New Drug Application (NDA) for UGN-102 beginning in January 2024. The PR also highlighted the successful clinical trials of UGN-102, with ENVISION and ATLAS Phase 3 trials meeting their primary endpoints in treating LG-IR-NMIBC. Furthermore, the company achieved quarterly net product revenue of $20.9 million for JELMYTO in the third quarter of 2023, representing ~30% growth over the third quarter of 2022. The financial results for the third quarter of 2023 were also provided, including revenue, R&D expenses, SG&A expenses, net loss, and cash & cash equivalents.
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UroGen will Present Scientific Advances in Bladder Cancer at the Annual Meeting of the Society of Urologic Oncology

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UroGen Pharma Ltd. (Nasdaq: URGN) will present data from the Phase 3 ENVISION and ATLAS trials evaluating UGN-102, an investigational treatment for LG-IR-NMIBC at the 2023 Society of Urologic Oncology (SUO) annual meeting. These trials aim to broaden the understanding of using a new approach to treat bladder cancer, fulfilling unmet needs with non-surgical options. The ENVISION trial will be presented as a late-breaking oral presentation, and the ATLAS trial will be presented in a digital poster session.
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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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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.

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UroGen Pharma Ltd. Ordinary Shares

Nasdaq:URGN

URGN Rankings

#3187 Ranked by Market Cap
N/A Ranked by Dividends

URGN Stock Data

449.00M
37.83M
9.18%
92.27%
15.27%
Biotechnology
Pharmaceutical Preparations
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United States of America
RA'ANANA