Welcome to our dedicated page for Urogen Pharma news (Ticker: URGN), a resource for investors and traders seeking the latest updates and insights on Urogen Pharma stock.
UroGen Pharma Ltd. (URGN) is a biotechnology company whose news flow centers on therapies for urothelial and specialty cancers. Company announcements highlight the development and commercialization of RTGel®-based mitomycin formulations and other oncology candidates designed for non-surgical tumor ablation in the urinary tract.
On this page, readers can follow news about Jelmyto for low-grade upper tract urothelial cancer and ZUSDURI™ (mitomycin) for intravesical solution, described by UroGen as the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Updates often cover regulatory milestones such as U.S. Food and Drug Administration approvals, the assignment of a permanent HCPCS Level II J Code (J9282) for ZUSDURI, and coverage or reimbursement developments that affect access to treatment.
UroGen’s disclosures also include clinical trial results and pipeline progress, including data from the Phase 3 UTOPIA trial of UGN-103 for recurrent LG-IR-NMIBC, the clinical development program for ZUSDURI across studies such as OPTIMA II, ATLAS, and ENVISION, and ongoing work on next-generation candidates UGN-104 and UGN-501. Investors and healthcare professionals can track conference presentations, financial result releases, and corporate updates, such as inducement equity grants and proxy-related matters.
By reviewing the URGN news feed on Stock Titan, users can monitor how UroGen’s RTGel platform, approved products, and late-stage pipeline evolve over time, and how regulatory, clinical, and commercial developments may influence the company’s oncology portfolio.
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.
UroGen Pharma Ltd. (Nasdaq: URGN) reported its Q4 and full-year 2020 financial results, marking a significant transition with the launch of Jelmyto, achieving $8.0 million in Q4 product revenue and $11.8 million since its launch on June 1, 2020. The company initiated the Phase 3 ATLAS trial for UGN-102 and established a collaboration with MD Anderson for UGN-302. UroGen reported a net loss of $30.5 million for Q4 2020 and $128.5 million for the full year, with cash reserves of $103.9 million as of December 31, 2020. Guidance for 2021 operating expenses is $155 to $170 million.
UroGen Pharma Ltd. (Nasdaq: URGN) has secured a strategic funding agreement with RTW Investments, LP, receiving $75 million upfront. The agreement entails tiered future cash payments based on global sales of Jelmyto® and UGN-102, contingent on specific sales milestones. Future payments will cease once RTW receives a total of $300 million. UroGen aims to utilize this non-dilutive funding to bolster the launch of Jelmyto and advance the ongoing Phase 3 ATLAS study for UGN-102, reflecting its commitment to developing treatments for urologic cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announced a research agreement with Johns Hopkins University to explore immunotherapy for glioblastoma multiforme (GBM) using RTGel™ technology. This proprietary hydrogel aims to enhance drug exposure and efficacy in local immunotherapy delivery. The research, expected to start in Q2 2021, focuses on using checkpoint inhibitors to combat GBM, which has a less than 5% five-year survival rate. UroGen's advancements in immuno-oncology include UGN-302 for high-grade non-muscle invasive bladder cancer.
UroGen Pharma Ltd. (Nasdaq: URGN) announces the release of its fourth quarter and full year 2020 financial results on March 18, 2021, before market opening. This will be followed by a live audio webcast and conference call at 8:30 AM ET. UroGen is focused on innovative solutions for specialty cancers and urologic diseases, with its first commercial product, UGN-102, aimed at treating low-grade non-muscle invasive bladder cancer. The company utilizes its proprietary RTGel™ technology to enhance drug efficacy through sustained release in the urinary tract.
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