Articles from UroGen Pharma Ltd.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 7 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report fourth quarter and full-year 2024 financial results on Monday, March 10, 2025, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference to take place on March 3-5, 2025.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced expansion of its oncology pipeline portfolio through the acquisition of assets relating to a next-generation oncolytic virus ICVB-1042 from IconOVir Bio, Inc. (IconOVir). In addition, UroGen also announced that it has entered into multiple strategic research collaborations to explore the potential of its proprietary RTGel technology to enhance clinical effectiveness of multiple immunotherapies, including optimizing dwell time to improve treatment outcomes.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from the subgroup analyses of the pivotal ENVISION study evaluating the impact of tumor burden and focality on the response to UGN-102, an investigational drug in development for treatment of LG-IR-NMIBC. Analyses of pre-specified subgroups showed comparable CR rates and DOR patterns across different levels of tumor burden (defined as the sum of the diameters of all visible tumors) and number of tumors at baseline in patients treated with UGN-102. The poster presentation titled, Impact of Tumor Burden or Focality in Recurrent Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer on Response to Treatment with UGN-102: A Substudy of the Phase 3 ENVISION Trial was presented today at ASCO GU 2025.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO® (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult patients. Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41, 20 of whom entered the long-term follow-up study), the median duration of response was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]). The study results are published in the March issue of The Journal of Urology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate at the following investor conferences in February:

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights results from a study on the durability of response from the first and largest post-commercialization study of JELMYTO® (mitomycin) for pyelocalyceal solution. The long-term study evaluated 56 patients who achieved complete response after treatment with JELMYTO from 15 high-volume academic and community centers and helps characterize how urologists are now using JELMYTO in their practices. This long-term study titled, “Durability of Response of UGN-101: Longitudinal Follow-Up of Multicenter Study,” is published online in Urologic Oncology: Seminars and Investigations.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the 3-month complete response (CR) rate and 12-month durability of response from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published in the February issue of The Journal of Urology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 35 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of adults with low-grade, upper tract urothelial cancer (LG-UTUC). Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41, 20 of whom entered the long-term follow-up study), the median duration of response was 47.8 months (median follow-up 28.1 months (95% CI 13.1, 57.5). The study results were presented at the Society for Urologic Oncology (SUO) annual meeting in Dallas, Texas, and were recently published online in the Journal of Urology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the presentation of the Phase 3 ENVISION trial’s efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX. These results, published online in the Journal of Urology in October, demonstrate that treatment with investigational therapy UGN-102, a mitomycin-based intravesical solution, resulted in a high and clinically meaningful complete response rate that was durable in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that new data on UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution, and UGN-301(zalifrelimab intravesical solution) will be presented at the Society of Urologic Oncology (SUO) 2024 annual meeting being held in Dallas, Texas from December 4 – 6.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult patients. Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with JELMYTO (n=41, 20 of whom entered the long-term follow-up study), the median duration of response was 47.8 months (median follow-up 28.1 months [95% CI 13.1, 57.5]). The study results are published online in the Journal of Urology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2024, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will participate in a fireside chat at the Guggenheim Securities Healthcare Innovation Conference to take place November 11-13, 2024.

UroGen Pharma Ltd. (Nasdaq:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report 2024 third quarter financial results on Wednesday, November 6, 2024, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that new long-term durability of response results from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published online in the Journal of Urology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that Chris Degnan has been appointed Chief Financial Officer. Mr. Degnan succeeds Don Kim, who is leaving UroGen to pursue other opportunities.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103 is a next-generation novel mitomycin-based formulation.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/535,108 entitled “Material and Method for Treating Cancer.”

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 19 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate in fireside chats at the following investor conferences in September:

UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company specializing in novel therapies for urothelial and specialty cancers, today announced the successful completion of its New Drug Application (NDA) submission for investigational drug UGN-102, (mitomycin) for intravesical solution, a significant step forward in potentially addressing the urgent need for innovative treatments for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UroGen anticipates potential FDA approval in early 2025, if the NDA is accepted for filing by the FDA and priority review is granted.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the second quarter ended June 30, 2024, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report second quarter 2024 financial results on Tuesday, August 13, 2024, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the pricing of an underwritten public offering of 5,000,000 ordinary shares at a price to the public of $17.50 per ordinary share, and, to certain investors in lieu of issuing ordinary shares, pre-funded warrants to purchase 1,142,857 ordinary shares at a purchase price of $17.499 per pre-funded warrant, which equals the public offering price per ordinary share less the $0.001 per share exercise price for each pre-funded warrant. The gross proceeds to UroGen from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $107.5 million. In addition, UroGen granted the underwriters a 30-day option to purchase up to an additional 921,428 ordinary shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 20, 2024, subject to satisfaction of customary closing conditions.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced 82.3% (95% CI, 75.9%, 87.1%) 12-month duration of response (DOR) data by Kaplan-Meier estimate (n=108) from its Phase 3 ENVISION trial in patients who achieved complete response (CR) at three months after the first instillation of investigational drug UGN-102 (mitomycin) for intravesical solution. The ENVISION trial previously met its primary endpoint by demonstrating that patients treated with UGN-102 had a 79.6% (95% CI, 73.9%, 84.5%) CR rate at three months following the first instillation of UGN-102.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) and an option (“Option”) to 15 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today shared additional details about the upcoming ENVISION virtual data event on Thursday, June 13, 2024, at 11:00 a.m. Eastern Time. The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will participate in a fireside chat at the 45th Annual Goldman Sachs Global Healthcare Conference to take place June 10-13, 2024.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that David Lin will join UroGen as its Chief Commercial Officer and member of the Executive Leadership Team. In this role, David will be spearheading UroGen’s commercial strategy, including preparation for the potential launch of our lead pipeline candidate UGN-102, if approved, and driving the continued growth and commercialization of JELMYTO® (mitomycin) for pyelocalyceal solution.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will participate in a virtual fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit on Tuesday, May 28, 2024 at 3:20 PM ET.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2024, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will present at the following investor conferences in May:

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first and largest real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2024 in San Antonio, TX. Among patients with low-grade Ta upper tract urothelial carcinoma (UTUC) who were complete responders to induction therapy (n=53), JELMYTO was associated with an 86% recurrence-free survival rate at 24 months across diverse patient types regardless of initial disease characteristics or usage for chemoablation versus post-endoscopic ablation. Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from a new analysis of the ATLAS trial, which estimates using Kaplan Meier methods the probabilities of remaining in complete response for both new and recurrent low-grade intermediate-risk non- muscle invasive bladder cancer (LG-IR-NMIBC) patients following treatment with investigational drug UGN-102 as primary therapy, with or without subsequent transurethral resection of the bladder tumor (TURBT) at 3 months.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from a real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2024 in San Antonio, TX. The study includes a stepwise approach to retrograde administration of JELMYTO and reports that retrograde administration of JELMYTO in the clinic (n=20) produced a 60% complete response rate in patients and ureteral stents were placed in 25% of patients, which is lower than the rate reported in the pivotal OLYMPUS study.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report 2024 first quarter financial results on Monday, May 13, 2024, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that new data on investigational drug UGN-102 (mitomycin) and JELMYTO and will be presented at the American Urological Association (AUA) 2024 Annual Meeting being held in San Antonio, Texas from May 3 – 6.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”). Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution. JELMYTO® is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 12 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report fourth quarter and full-year 2023 financial results on Thursday, March 14, 2024, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will present at TD Cowen’s 44th Annual Health Care Conference on Monday, March 4, 2024 at 1:30pm EST.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will present at the following investor conferences in February:

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the submission of 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).

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that Liz Barrett, President and CEO, will participate in a fireside chat at the upcoming B. Riley Virtual Healthcare Conference on January 18th beginning at 12:00 p.m. ET.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 17 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2023, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, will highlight data from two key Phase 3 trials evaluating UGN-102, an investigational treatment in development for LG-IR-NMIBC at the 2023 Society of Urologic Oncology (SUO) annual meeting, November 28-December 1 in Washington D.C. These data presentations further UroGen’s mission of developing and commercializing innovative treatments for urothelial and specialty cancers that provide patients with novel non-surgical options to fulfill the unmet needs that exist with current standards of care.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report third quarter 2023 financial results on November 14, 2023, at 8:00 AM EDT, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on plans for submission of a New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution. The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response (CR) at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024. If approved, UGN-102 has the potential to introduce a new non-surgical treatment paradigm for LG-IR-NMIBC, a subset of bladder cancer patients characterized by high recurrence rates and the need for multiple surgeries.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 11 new employees, as well as options (“Options”) to one of the new employees, in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it will present at the following investor conferences in September:

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the second quarter ended June 30, 2023, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that The Journal of Urology published data from the Phase 3 ATLAS trial for investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), that demonstrated superiority to transurethral resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102. Tumor-free complete response rate at three months was 65% for patients who only received UGN-102, compared to a 64% complete response rate at three months for patients who underwent TURBT. TURBT is the current standard of care for patients with this type of cancer.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report second quarter 2023 financial results on Thursday, August 10, 2023, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN) a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) and options (“Options”) to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing employment with UroGen.

UroGen Pharma Ltd. (Nasdaq: URGN) (UroGen), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has entered into a definitive securities purchase agreement in connection with a private placement (the Private Placement) to selected institutional and accredited investors. RA Capital Management L.P. and Great Point Partners LLC led the Private Placement, which also included Acorn Bioventures, Monograph Capital and Horton Capital Partners Fund, LP. UroGen expects to receive gross proceeds of approximately $120 million, before deducting placement agent commissions and other offering expenses.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced positive topline data from its Phase 3 trials ATLAS and ENVISION studying UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Both ATLAS and ENVISION trials met their primary endpoints.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the appointment of James Robinson, former President and Chief Executive Officer (CEO) of Urovant Sciences, to its Board of Directors, effective immediately.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first post-commercial utilization review of JELMYTO (mitomycin) for pyelocalyceal solution. This study assessed the efficacy of JELMYTO in managing patients with larger volume disease where initial tumor burden may not be amenable to complete mechanical ablation or renal preservation. Findings from the study titled, The Ablative Effect of Mitomycin Reverse Thermal Gel: Expanding the Role for Nephron Preservation Therapy in Low Grade Upper Tract Urothelial Carcinoma, are published in Urologic Oncology: Seminars and Original Investigations online.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it will host a data event on Thursday, July 27th, 2023 at 10:00 a.m. Eastern Time. The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and will highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first post-commercial utilization review of JELMYTO® (mitomycin) for pyelocalyceal solution. This is the first study to compare modes of administration for JELMYTO, an approved treatment for low-grade upper tract urothelial cancer (LG-UTUC) in adult patients. Findings from the study titled, Route of Administration for UGN-101 and Impact on Oncological and Safety Outcomes, are published in the European Urology Focus online.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 6 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will present at the following investor conferences in June:

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will report 2023 first quarter financial results on Thursday, May 11, 2023, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO (mitomycin) for pyelocalyceal solution presented today at the American Urological Association Meeting 2023 in Chicago, IL. The study titled, “Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma Early Experience with UGN-101 for the Treatment of Upper Tract Urothelial Cancer – A Multi-Center Evaluation of Practice Patterns and Outcomes,” is also published in the May issue of The Journal of Urology.

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO® (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2023 in Chicago, IL. The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors. The investigators reported no difference in outcomes at first endoscopic evaluation based on UTUC tumor location (ureter vs. renal pelvis) (p=0.644). JELMYTO is approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.