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.

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) Moves 10.3% Higher: Will This Strength Last?

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 host a thought leader webinar on non-muscle-invasive bladder cancers (NMIBC) and the potential role of the Company's investigational product candidate, UGN-102, to treat low-grade intermediate-risk NMIBC (LG-IR-NMIBC) on Tuesday, October 18, 2022 at 9:00 AM Eastern Time. T

UroGen Pharma to Host Thought Leader Webinar on UGN-102 and Non-Muscle Invasive Bladder Cancers

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 the U.S. Food and Drug Administration (FDA) has authorized an extension of the in-use period for JELMYTO® (mitomycin) for pyelocalyceal solution admixture from 8 hours to 96 hours (four days) following reconstitution of the product. This extension is significant and has implications fo

FDA Authorizes an Extension of the In-Use Period for UroGen Pharma's JELMYTO® Admixture to 96 Hours Following Reconstitution

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 appointment of Dr. Leana S. Wen to its Board of Directors, effective immediately. Dr. Leana S. Wen, an emergency medicine physician and public health and policy expert, has agreed to join UroGen's board, effective immediately. She has served as a professor of health policy and managemen

UroGen Announces the Appointment of Dr. Leana S. Wen to the UroGen Pharma Board of Directors

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 healthcare conferences in September: H.C. Wainwright & Co. Annual Global Investment Conference Tuesday, September 13 at 10:30 a.m. ET Ladenburg Thalmann Healthcare Conference Analyst Discussion on Thursday, September 29 at 8:30 a.m. ET Webcasts

UroGen Pharma Announces Upcoming 2022 Conferences

Urogen Pharma Ltd (NASDAQ:URGN ) Q2 2022 Earnings Conference Call August 11, 2022 10:00 AM ET Company Participants Vincent Perrone - Senior Director, IR Elizabeth Barrett - President, CEO & Director Mark Schoenberg - Chief Medical Officer Jeffrey Bova - Chief Commercial Officer Dong Kim - CFO Conference Call Participants Christopher Howerton - Jefferies Raghuram Selvaraju - H.C. Wainwright & Co. Boris Peaker - Cowen and Company Matthew Kaplan - Ladenburg Thalmann & Co. Leland Gershell - Oppenheimer Operator Ladies and gentlemen, thank you for standing by, and welcome to the UroGen Pharma second quarter 2022 update conference call.

Urogen Pharma Ltd (URGN) CEO Elizabeth Barrett on Q2 2022 Results - Earnings Call Transcript

Urogen Pharma (URGN) delivered earnings and revenue surprises of 11.28% and 2.02%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

Urogen Pharma (URGN) Reports Q2 Loss, Lags 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 second quarter ended June 30, 2022 and provided an overview of recent developments. “Positive momentum established last quarter has accelerated into the second quarter of 2022 and we remain confidently on track to meet our anticipated guidance, both financial

UroGen Pharma Reports Second Quarter 2022 Financial Results and Recent Corporate Developments

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 second quarter 2022 financial results on Thursday, August 11, 2022, 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. A live public webcast of the earnings conference call can be

UroGen Pharma to Report Second Quarter 2022 Financial Results on Thursday, August 11, 2022

NEW ORLEANS--(BUSINESS WIRE)-- #AUA2022--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today highlights new data on real-world experience utilizing the antegrade approach via nephrostomy tube for administration of JELMYTO® (mitomycin) for pyelocalyceal solution. This data adds to a growing body of evidence on the safety and efficacy profile of the antegrade method of administration for JELMYTO. These data were presen

UroGen Highlights New Data Presented at AUA that Adds to the Evidence Supporting In-Office Nephrostomy Tube Administration of JELMYTO®, the only Non-Surgical, Kidney-Sparing Treatment for Adults with Low Grade Upper Tract Urothelial Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN) today highlighted four presentations of interest featuring data on JELMYTO® (mitomycin) for pyelocalyceal solution for patients with low-grade upper tract urothelial cancer (LG-UTUC) and investigational agent UGN-102 (mitomycin) for intravesical solution in Phase 3 clinical development as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at the upcoming 2022 American U

UroGen Pharma Highlights Data Presentations at the 2022 American Urological Association Annual Meeting

UroGen Pharma Ltd. (NASDAQ:URGN ) Q1 2022 Earnings Conference Call May 10, 2022 10:00 AM ET Company Participants Vincent Perrone - Senior Director of IR Liz Barrett - President and CEO Mark Schoenberg - Chief Medical Officer Jeff Bova - Chief Commercial Officer Don Kim - CFO Conference Call Participants Ram Selvaraju - H.C.

UroGen Pharma Ltd. (URGN) CEO Liz Barrett on Q1 2022 Results - Earnings Call Transcript

Urogen Pharma (URGN) delivered earnings and revenue surprises of 8.09% and 13.16%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Urogen Pharma (URGN) Reports Q1 Loss, Misses 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 first quarter ended March 31, 2022, and provided an overview of recent developments. “The first quarter of 2022 saw further commercial, clinical and operational progress as we continued to grow patient access to Jelmyto, advance our clinical-stage candidates a

UroGen Pharma Reports First Quarter 2022 Financial Results and Recent Corporate Developments

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 first quarter 2022 financial results on Tuesday, May 10, 2022, 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. Audio Webcast The webcast will be made available on the Investors

UroGen Pharma to Report First Quarter 2022 Financial Results on Tuesday, May 10, 2022

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 the U.S. Food and Drug Administration (FDA) has cleared UroGen's Investigational New Drug (IND) application to begin a novel Phase 1 clinical study of the anti-CTLA-4 immunotherapy UGN-301 (zalifrelimab) in patients with recurrent NMIBC. The multi-arm Phase 1 study is expected to

UroGen Announces FDA Clearance of IND Application for the Investigational Immunotherapy UGN-301 (zalifrelimab) Intravesical Solution in Recurrent Non-Muscle Invasive Bladder Cancer

UroGen Pharma Ltd.'s (URGN) CEO Liz Barrett on Q4 2021 Results - 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 fourth quarter and full year ended December 31, 2021, and overview of recent developments. “I am proud of the progress we made in 2021 on behalf of patients as we've expanded access to Jelmyto and set the stage for important commercial and clinical milestones

UroGen Pharma Reports Fourth Quarter and Full-year 2021 Financial Results and Recent Corporate Developments

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 the signing of an up to $100 million term loan financing facility with funds managed by Pharmakon Advisors, L.P. The loan facility will be available to UroGen, subject to the terms and conditions of the loan agreement, as follows: Senior secured term loan of up to $100 million in two t

UroGen Secures $100 Million Non-Dilutive Term Loan Financing with Pharmakon Advisors Allowing Funding to Cash Flow Breakeven

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 2021 financial results on Thursday, March 10, 2022, 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. Audio Webcast The webcast will be made ava

UroGen Pharma to Report Fourth Quarter and Full-Year 2021 Financial Results on Thursday, March 10, 2022

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 the submission of an Investigational New Drug application (IND) for UGN-301 (zalifrelimab) to the U.S. Food and Drug Administration (FDA) in support of the planned initiation of a multi-arm, Phase I clinical study for its anti-CTLA4 antibody. The study is expected to begin in the secon

UroGen Submits Investigational New Drug Application Supporting Planned Phase 1 Clinical Study of UGN-301 (zalifrelimab) Intravesical Solution in Recurrent Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq:URGN), a biotech company dedicated to developing and commercializing innovative solutions to treat urothelial and specialty cancers, today announced that it will participate in a panel discussion at the upcoming virtual Cowen 42nd Annual Healthcare Conference on March 8, 2022 at 10:30am Eastern Time. A live webcast of the panel will be available on the Investors & Media section of UroGen's website at www.urogen.com. A replay of th

UroGen Pharma to Participate in Panel Discussion at Cowen 42nd Annual Healthcare Conference

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today announced the first published report of real-world experience utilizing the antegrade approach for Jelmyto® (mitomycin) for pyelocalyceal solution administration in the Journal of Urology online on February 7, 2022. This report provides a stepwise treatment approach to low-grade Upper Tract Urothelial Cancer (LG UTUC) fro

UroGen Announces Data that Shows In-Office Nephrostomy Tube Administration of Jelmyto® is Efficient for Doctors and Well Tolerated by Patients

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin) for intravesical solution, in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC). ENVISION is a single-arm, multinational, multicenter study evaluating the efficacy and safety of U

UroGen Announces Start of Pivotal Single-Arm Phase 3 Trial for UGN-102, an Investigational Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it will present at the following virtual healthcare conferences in January: 40th Annual J.P. Morgan Healthcare Conference Thursday, January 13 at 9:45 a.m. ET HC Wainwright BioConnect Conference Presentation available on-demand beginning Monday, January 10 at 7:00 a.m. ET Webca

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