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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.
UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) to 19 new employees. This initiative supports the ongoing launch of Jelmyto® for pyelocalyceal solution, UroGen's first approved product, and the development of its pipeline. A total of 94,800 shares of common stock are issuable upon the vesting of these RSUs, which will vest equally over three years. The RSUs comply with Nasdaq Rule 5635(c)(4) and are part of the company's 2019 Inducement Plan.
UroGen Pharma Ltd. (Nasdaq: URGN) reported financial results for Q2 2021, highlighting strong revenue growth from its product Jelmyto, which generated $13.0 million, a 70% increase from Q1 2021. The company has activated 407 treatment sites, a 29% rise since May. UGN-102's pivotal Phase 3 ATLAS trial continues with nearly 100 sites enrolled. UroGen's net loss was $26.2 million with a cash position of $129.3 million as of June 30, 2021. The company anticipates operating expenses between $155 to $165 million for the year.
UroGen Pharma Ltd. (Nasdaq: URGN) has entered into an exclusive licensing agreement with Neopharm to market Jelmyto (mitomycin) in Israel, pending regulatory approval. Jelmyto is the first FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). Neopharm will handle the regulatory processes, supported by successful Phase 3 OLYMPUS trial results. UroGen aims to expand Jelmyto's availability beyond the U.S., emphasizing Israel's significance due to its foundational ties and local clinical trial contributions.
UroGen Pharma Ltd. (Nasdaq: URGN) will report its second quarter 2021 financial results on August 4, 2021, before market opening. The company will hold a live audio webcast and conference call at 8:30 AM Eastern Time to discuss these results. UroGen specializes in biopharmaceutical solutions for specialty cancers and urologic diseases, with its first commercial product being UGN-102, an investigational treatment for low-grade non-muscle invasive bladder cancer. More information can be accessed through UroGen's investor relations webpage.
UroGen Pharma Ltd. (Nasdaq: URGN) announced expected net product revenue from Jelmyto sales of approximately $13 million for Q2 2021, marking a 70% increase from Q1 2021 and the highest since its launch in June 2020. Operating expenses are anticipated to be between $33 to $38 million. As of June 30, 2021, cash and equivalents are projected at $129 million. The company reaffirms its full-year operating expense guidance of $155 to $165 million. UroGen plans to report complete Q2 results on August 4, 2021.
UroGen Pharma Ltd (Nasdaq:URGN), a biopharmaceutical company specializing in treatments for urologic diseases and specialty cancers, will present at the Ladenburg Thalmann Healthcare Conference on July 14, 2021, at 12:00 PM ET. A live webcast of the event will be accessible on the Investors section of UroGen's website. The company is known for its innovative RTGel™ technology, enhancing drug delivery for bladder cancer treatments, including its investigational product UGN-102. The webcast replay will be available for 30 days.
UroGen Pharma Ltd. (Nasdaq: URGN) announced the granting of inducement restricted stock units (RSUs) to eleven new employees to support the launch of Jelmyto® and the development of its pipeline. Up to 46,100 shares are issuable, vesting over three years. This initiative aligns with Nasdaq Rule 5635(c)(4) as a material inducement for employment.
UroGen focuses on innovative treatments for specialty cancers and urologic diseases, leveraging its RTGel™ technology for improved therapeutic outcomes.
UroGen Pharma Ltd. (Nasdaq: URGN) will present at two virtual healthcare conferences in June 2023. The Jefferies Virtual Healthcare Conference is on June 2 at 11:30 AM ET, and the Goldman Sachs 42nd Annual Global Healthcare Conference is on June 9 at 8:50 AM ET. Live webcasts will be available on UroGen's website, with replays accessible for approximately 30 days. UroGen focuses on treating specialty cancers and urologic diseases, developing innovative treatments like RTGel™ and UGN-102 for bladder cancer.
UroGen Pharma Ltd. (Nasdaq: URGN) reported a significant increase in momentum during Q1 2021, achieving net product revenue of $7.5 million from Jelmyto. Patient enrollment in clinical trials surged, with over 316 sites activated, marking a 26% increase. R&D expenses decreased to $10.5 million, down from $16.6 million in Q1 2020. The company experienced a net loss of $25.9 million, an improvement from $37.8 million the previous year. UroGen aims to reduce operating expenses to $155-$165 million for 2021, aided by a $75 million financing deal.
UroGen Pharma Ltd. (Nasdaq: URGN) will report its first quarter 2021 financial results on May 13, 2021, before market open. This will be followed by a live audio webcast at 8:30 AM ET. UroGen focuses on developing treatments for specialty cancers and urologic diseases, with its proprietary RTGel™ platform aiming to enhance the therapeutic profiles of existing drugs. UGN-102, their first commercial product for low-grade non-muscle invasive bladder cancer, offers a non-surgical treatment option.
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