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 (Nasdaq: URGN), a biotech firm focused on treating urothelial and specialty cancers, announced the start of an underwritten public offering of its ordinary shares and pre-funded warrants. The offering's completion and terms depend on market conditions. UroGen plans to grant underwriters a 30-day option to buy an additional 15% of the total shares offered, including pre-funded warrants. TD Cowen and Guggenheim Securities will act as joint book-running managers, while Oppenheimer & Co. and Ladenburg Thalmann will serve as lead and co-managers, respectively. The offering is being made under a shelf registration statement filed with the SEC, effective as of November 29, 2022. Copies of related documents can be obtained from TD Securities or Guggenheim Securities.
UroGen Pharma announced that its Phase 3 ENVISION trial for UGN-102, targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), achieved an 82.3% duration of response (DOR) at 12 months. The trial showed a complete response (CR) rate of 79.6% at three months. The Kaplan-Meier estimates for DOR at 15 and 18 months were both 80.9%. The safety profile was consistent with previous trials, with common side effects including dysuria, hematuria, and urinary tract infection. UroGen has initiated a New Drug Application (NDA) to the FDA, aiming for a decision by Q1 2025. A virtual event discussing these results is scheduled for today at 11:00 AM ET.
UroGen Pharma (Nasdaq: URGN) has announced the grant of inducement restricted stock units (RSUs) and an option to 15 new employees, including Chief Commercial Officer David Lin. Up to 52,500 shares will be issued upon vesting for 14 employees, and up to 13,041 shares plus 71,942 shares upon the exercise of an option will be issued for Lin. RSUs and options vest over three years, contingent on continued employment. The exercise price for the option is set at $13.13, the closing price on June 3, 2024. These grants are under UroGen's 2019 Inducement Plan, following Nasdaq Listing Rule 5635(c)(4), to support the commercialization of Jelmyto and pipeline development.
UroGen Pharma (Nasdaq: URGN) will host a virtual event on June 13, 2024, at 11:00 a.m. ET, to present the 12-month durability response results from its Phase 3 ENVISION trial. This trial assesses UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The focus will be on patients who showed a complete response at three months after six weekly doses. The event will include insights from Key Opinion Leaders and a panel discussion. A replay will be available on the company's website after the event.
UroGen Pharma (Nasdaq: URGN) announced its participation in the 45th Annual Goldman Sachs Global Healthcare Conference. The event will occur in Miami, FL, from June 10-13, 2024, and UroGen's management will present on June 11 at 3:20 PM ET. The presentation will be in a fireside chat format. A webcast will be available live and for replay for approximately 90 days on the company's investor relations website.
UroGen Pharma (NASDAQ: URGN) has appointed David Lin as the new Chief Commercial Officer. Lin, who boasts extensive experience from Bristol Myers Squibb and other significant roles in the pharmaceutical industry, will lead UroGen's commercial strategy. His key responsibilities include preparing for the potential launch of UGN-102 and enhancing the commercialization of JELMYTO® (mitomycin). Lin's background includes successful launches of CAR T therapies and global expansion initiatives. Jeff Bova, the former CCO, will step down on June 3 to pursue new opportunities.
UroGen Pharma (Nasdaq: URGN), a biotech firm focused on urothelial and specialty cancers, will participate in a virtual fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit. The event is scheduled for May 28, 2024, at 3:20 PM ET. Investors can access a live webcast through the company's website. This event presents an opportunity for UroGen to discuss its innovative cancer treatments and engage with stakeholders.
UroGen Pharma announced ENVISION study data, JELMYTO durability results, and financials for Q1 2024. JELMYTO net sales grew to $18.8 million, IND accepted for UGN-103, and UGN-102 NDA expected in Q3 2024. JELMYTO post-hoc analysis showed a median disease-free period of 47.8 months in LG-UTUC. UroGen also entered a licensing agreement for next-gen mitomycin-based UGN-103 to treat urothelial cancers.
UroGen Pharma (URGN) is set to participate in upcoming investor conferences like Citizens JMP Life Sciences Conference and H.C. Wainwright BioConnect Conference in May 2024. The company aims to present its innovative solutions for urothelial and specialty cancers, showcasing its commitment to developing and commercializing effective treatments.
UroGen Pharma has presented a real-world retrospective analysis at AUA 2024, reporting an 86% Recurrence-Free Survival (RFS) at 24 months with JELMYTO® for patients with low-grade Ta upper tract urothelial carcinoma who were complete responders to induction therapy. No differences in RFS were found based on treatment usage, tumor characteristics, or timing of administration. Patients who received maintenance therapy showed a 100% RFS at 24 months compared to 61% for those who did not receive maintenance therapy. These results suggest JELMYTO's potential in treating UTUC and improving long-term outcomes.