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 announced promising results from the Phase 2b OPTIMA II trial for UGN-102, a non-surgical treatment for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The trial showed a 65% complete response rate at three months, with 61% of patients maintaining complete response at 12 months. The data supports ongoing Phase 3 development, indicating UGN-102's potential as a primary therapy for this patient demographic, which currently relies heavily on surgical interventions.
UroGen Pharma Ltd. (URGN), a biopharmaceutical company focused on specialty cancers and urologic diseases, will present at the Cantor Fitzgerald 2021 Virtual Global Healthcare Conference on September 30, 2021, at 3:20 p.m. ET. A live webcast will be accessible on UroGen’s website, with a replay available for 30 days. UroGen is known for its proprietary RTGel™ technology, aimed at enhancing drug delivery in urology. The company’s initial product, UGN-102, targets low-grade non-muscle invasive bladder cancer through non-surgical means.
UroGen Pharma Ltd. (NASDAQ: URGN) announced key results from the Phase 2b OPTIMA II trial of UGN-102, where 65% of patients with low-grade intermediate risk NMIBC achieved complete response at three months. Additionally, the Phase 3 OLYMPUS trial of Jelmyto revealed a 58% complete response rate in low-grade upper tract urothelial cancer patients, with an 81.8% durability rate at 12 months. Both trials were presented at the AUA Annual Meeting and highlight UroGen's focus on non-surgical treatments for urinary cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7:00 a.m. ET on September 13, 2021, through the conference portal and UroGen's website. UroGen focuses on developing innovative treatments for specialty cancers and urologic diseases, with its proprietary RTGel™ technology enhancing drug delivery to the urinary tract. Its investigational product, UGN-102, targets low-grade non-muscle invasive bladder cancer.
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.