UroGen Pharma

UroGen Pharma Ltd. is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases. It has developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. The firm's sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Its approved product Jelmyto (mitomycin) for pyelocalyceal solution and investigational treatment UGN-102 (mitomycin) for intravesical solution are designed to ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer and low-grade non-muscle invasive bladder cancer respectively. The company was founded by Asher Holzer in 2004 and is headquartered in Princeton, NJ.

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UroGen Pharma reports solid Q2 performance and bullish on UGN-102

UroGen Pharma's Q2 performance showcased revenue growth for JELMYTO and promising data for UGN-102, supported by a successful public offering to drive future initiatives.
Despite challenges in revenue performance and market expectations, the company's strong commercialization plans and confidence in UGN-102's potential position it well for sustained growth.
Opportunities lie in upcoming NDA submission, product portfolio expansion, and strategic use of raised funds, indicating a positive outlook for UroGen Pharma's future trajectory.

UroGen Pharma excels in Q3 with strong revenue growth and promising trial results

UroGen Pharma's Q3 performance reflects robust revenue growth, promising trial outcomes, and strategic advancements in product development and commercialization.
While facing challenges in operational scalability and financial management, UroGen's strong performance, patent portfolio, and market readiness offer a solid foundation for future success.
Opportunities lie in the upcoming UGN-102 commercial launch, market expansion, and continued innovation, positioning UroGen for sustained growth and competitive advantage.
Overall, UroGen Pharma's Q3 earnings call highlights a positive trajectory with key milestones achieved and a clear strategic roadmap for future growth.

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UroGen Pharma Ltd. is a biopharmaceutical company, which engages in developing and commercializing innovative solutions that treat urothelial and specialty cancers. It also focuses on developing RTGel reverse-thermal hydrogel, a proprietary sustained release and hydrogel-based platform technology. The company was founded by Asher Holzer in 2004 and is headquartered in Princeton, NJ.

ENVISION DOR data released in Q2, 2024 showed an unprecedented 82.3% Duration of Response for UGN-102. Following such positive data, it expects to make an FDA submission late in Q3, 2024, with potential for priority review. UroGen Pharma's blockbuster drug potential, liquidity, and modest market cap make it a strong buy.

UroGen: Q3 NDA Opens Hefty Revenue Opportunity

Urogen Pharma (URGN) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Urogen Pharma (URGN) Surges 9.7%: Is This an Indication of Further Gains?

UroGen stock rocketed Thursday on "unprecedented" test results for its bladder cancer treatment, a gel-based drug that avoids surgery.

UroGen Catapults On 'Unprecedented' Results For Gel-Based Cancer Drug

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AscellaHealth Chairman and President Bill Oldham Named 2024 Philadelphia Titan 100

PRINCETON, N.J.--(BUSINESS WIRE)--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 so.

UroGen Announces Unprecedented 82.3% Duration of Response at 12 Months in the ENVISION Trial Investigating UGN-102 as Potentially the First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC

PRINCETON, N.J.--(BUSINESS WIRE)--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). UroGe.

UroGen Pharma to Host UGN-102 Virtual Data Event on June 13, 2024

PRINCETON, N.J.--(BUSINESS WIRE)--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. Goldman Sachs 45th Annual Healthcare Conference Date/ time: June 11, 2024 at 3:20 PM ET Format: Fireside Chat Location: Miami, FL Webcast Li.

UroGen Pharma to Present at the 45th Annual Goldman Sachs Global Healthcare Conference

PRINCETON, N.J.--(BUSINESS WIRE)--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.

UroGen Pharma Appoints David Lin as New Chief Commercial Officer

PRINCETON, N.J.--(BUSINESS WIRE)--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. A live webcast of the fireside chat can be accessed by visiting the Events and Presentations Section of the Company's website: https.

UroGen Pharma to Present at the TD Cowen 5th Annual Oncology Innovation Summit

UroGen Pharma Ltd. (NASDAQ:URGN ) Q1 2024 Earnings Conference Call May 13, 2024 10:00 AM ET Company Participants Vincent Perrone - Head of IR Elizabeth Barrett - President & CEO Mark Schoenberg - Chief Medical Officer Don Kim - CFO Jeff Bova - Chief Commercial Officer Conference Call Participants Tara Bancroft - TD Cowen Raghuram Selvaraju - H.C.

UroGen Pharma Ltd. (URGN) Q1 2024 Earnings Call Transcript

PRINCETON, N.J.--(BUSINESS WIRE)--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. “In 2024 to date, UroGen has made excellent progress in both our commercial business and pipeline of innovative products designed to treat urothelial and specialty cancers,” s.

UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights

PRINCETON, N.J.--(BUSINESS WIRE)--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: Citizens JMP Life Sciences Conference – May 14, 2024 Fireside Chat: May 14, 2024 at 10:00am ET Location: New York, NY Webcast Registration Link: Here H.C. Wainwright BioConnect Conference – May 20, 2024 Fireside Chat: M.

UroGen Pharma to Participate at Upcoming Investor Conferences

PRINCETON, N.J.--(BUSINESS WIRE)--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 (U.

New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO® Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction Therapy

PRINCETON, N.J--(BUSINESS WIRE)--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 inves.

UroGen Announces Results from ATLAS Showing Robust UGN-102 Durability of Response in New and Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer at AUA 2024

PRINCETON, N.J.--(BUSINESS WIRE)--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 repor.

New Real-World Study on Retrograde Instillation of JELMYTO® for Treatment of Low-Grade Upper Tract Urothelial Cancer Reports Similar Complete Response Rate and Lower Stricture Rate Compared to OLYMPUS Pivotal Trial

PRINCETON, N.J.--(BUSINESS WIRE)--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. A live public webcast of the earnings conference call can be.

UroGen Pharma to Report 2024 First Quarter Financial Results on Monday, May 13, 2024

PRINCETON, N.J.--(BUSINESS WIRE)--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. “We are proud that the AUA selected the ATLAS post-hoc analysis as a podium pres.

UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers

PRINCETON, N.J.--(BUSINESS WIRE)--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). The UGN-103 formulation uses UroGe.

UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--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 '0.

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

UroGen Pharma Ltd. (URGN) Q4 2023 Earnings Call Transcript

Urogen Pharma (URGN) came out with a quarterly loss of $0.72 per share versus the Zacks Consensus Estimate of a loss of $0.67. This compares to loss of $1.22 per share a year ago.

Urogen Pharma (URGN) Reports Q4 Loss, Tops Revenue Estimates

PRINCETON, N.J.--(BUSINESS WIRE)--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. “In 2023, UroGen achieved important operational and clinical milestones, setting us up for further success in the coming years,” said Liz Barrett, President.

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

PRINCETON, N.J.--(BUSINESS WIRE)--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. A live public webcast of the earnings conf.

UroGen Pharma to Report Fourth Quarter and Full-Year 2023 Financial Results on Thursday, March 14, 2024

PRINCETON, N.J.--(BUSINESS WIRE)--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. TD Cowen 44th Annual Health Care Conference – March 4-6, 2024 Presentation: March 4, 2024 at 1:30 PM ET Location: Boston, MA Webcast Link: TD Cowen 44th Annual Health Care Conf.

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