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.

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 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 mec.

Retrospective Study Finds JELMYTO® Use Effective Following Partial Ablation or Biopsy in Larger Volume Low-Grade Upper Tract Urothelial Tumors that Impede Kidney Preservation

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 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 fr.

UroGen Pharma to Host UGN-102 Data Event on July 27, 2023

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 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 ad.

Retrospective Study Reveals Lower Stricture Rate and Comparable Oncological Outcomes with Antegrade Administration of JELMYTO® Versus Retrograde Administration

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 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 co.

UroGen Pharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Urogen Pharma Ltd (NASDAQ:URGN ) Q1 2023 Earnings Conference Call May 11, 2023 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 Raghuram Selvaraju - H.C. Wainwright & Co. Roderick Ma - Goldman Sachs Group Matthew Kaplan - Ladenburg Thalmann & Co. Rohan Mathur - Oppenheimer Boris Peaker - TD Cowen Operator Good morning, ladies and gentlemen.

Urogen Pharma Ltd (URGN) Q1 2023 Earnings Call Transcript

Urogen Pharma (URGN) came out with a quarterly loss of $1.30 per share versus the Zacks Consensus Estimate of a loss of $1.39. This compares to loss of $1.25 per share a year ago.

Urogen Pharma (URGN) Reports Q1 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 first quarter ended March 31, 2023, and provided an overview of recent developments. “2023 is off to a promising start as we reported double-digit year-over-year growth in worldwide JELMYTO net sales during the first quarter,” said Liz Barrett, President, and.

UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 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 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. A live public webcast of the earnings conference call can b.

UroGen Pharma to Report 2023 First Quarter Financial Results on Thursday, May 11, 2023

Urogen Pharma (URGN) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Urogen Pharma (URGN) Q1 Earnings Expected to Decline

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 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 (UG.

First Study to Evaluate JELMYTO® Use Post-Complete Endoscopic Ablation Reports 69% of Patients were Disease Free at the Time of First Endoscopic Evaluation

PRINCTON, 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 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 UG.

New Retrospective Study Presented at AUA 2023 Provides Evidence of Similar Outcomes Utilizing JELMYTO® in the Treatment of UTUC of the Ureter and Renal Pelvis

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 participate in a fireside chat at the upcoming H.C. Wainwright BioConnect Conference on May 2, 2023 at 10:00 AM ET. A live audio webcast will be available in the "Events and Presentations" section of UroGen's investor website. A replay will be available for approximately 3.

UroGen Pharma to Present at H.C. Wainwright BioConnect Conference

UroGen Pharma Ltd. (NASDAQ:URGN ) Q4 2022 Earnings Conference Call March 16, 2023 10:00 AM ET Company Participants Vincent Perrone – Head-Investor Relations Liz Barrett – President and Chief Executive Officer Mark Schoenberg – Chief Medical Officer Jeff Bova – Chief Commercial Officer Don Kim – Chief Financial Officer Conference Call Participants Leland Gershell – Oppenheimer Mitchell Kapoor – HCW Matt Kaplan – Ladenburg Thalmann Operator Good day and thank you for standing by.

UroGen Pharma Ltd. (URGN) Q4 2022 Earnings Call Transcript

Urogen Pharma (URGN) delivered earnings and revenue surprises of -8.93% and 0.87%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Urogen Pharma (URGN) Reports Q4 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 fourth quarter and full year ended December 31, 2022, and overview of recent developments.

UroGen Pharma Reports Highest Revenue Quarter and Significant Full Year 2022 Growth 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 fourth quarter and full-year 2022 financial results on Thursday, March 16, 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 to Report Fourth Quarter and Full-Year 2022 Financial Results on Thursday, March 16, 2023

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 preliminary results of a study to assess the feasibility of home instillation of UGN-102 (mitomycin) for intravesical solution, an investigational therapy in development for primary chemoablation of low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Investigational Therapy UGN-102 May Be Delivered at Home for the Treatment of Bladder Cancer

UroGen has an approved drug and a platform. However, there's not much growth in revenue.

UroGen: Struggling With Revenue And With Cash Runway

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 highlights results from the first and largest post-commercial utilization review of JELMYTO® (mitomycin) for pyelocalyceal solution. This study evaluated 132 patients treated with JELMYTO from 15 high-volume academic and community centers and characterizes the manner in which urologists are now using JELMYTO in their practices. The study titled, “Early Experience with UGN-101 for the Treatment of Upper Tract Urothelial Cancer – A Multi-Center Evaluation of Practice Patterns and Outcomes,” is published in Urologic Oncology: Seminars and Original Investigations.

Results of the First Post-Commercial Utilization Review of JELMYTO® Provide New Evidence that Reinforces its Efficacy and Safety in Patients with Low-Grade Upper Tract Urothelial Cancer

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, announced that the Phase 3 ENVISION study of investigational agent UGN-102 (mitomycin) for intravesical solution in development for the treatment of LG-IR-NMIBC is fully enrolled. The ENVISION study targeted enrollment of 220 patients across 90 sites and, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.

UroGen Completes Enrollment of Its Phase 3 Clinical Trial for UGN-102 in Development for Low-Grade, Intermediate-Risk, Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

SAN DIEGO--( 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 new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102 that shows median duration of response (DOR) of 24.4 months for UroGen's investigational drug UGN-102 currently in Phase 3 development for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study (Abstract #193) was presented at SUO on December 2.

UroGen Announces New Data from the OPTIMA II Study that Show Median Durability of Response of 24.4 Months for UGN-102, an Investigational Non-Surgical Chemoablative Treatment for Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer

SAN DIEGO--( BUSINESS WIRE )--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today announced new data from the OLYMPUS registration trial designed to obtain long-term follow-up data on JELMYTO® (mitomycin) for pyelocalyceal solution that shows median durability of response (DOR) of 28.9 months. The study (Abstract #158) was presented at SUO on December 1.

UroGen Announces New Data from the OLYMPUS Trial that Shows Median Durability of Response of 28.9 Months for JELMYTO®, the Only Non-Surgical, Chemoablative Treatment for Adults with Low-Grade Upper Tract Urothelial Cancer

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 participate in a virtual fireside chat at the upcoming Evercore ISI 5th Annual HealthCONx Conference on November 29, 2022 at 3:55 PM ET.

UroGen Pharma to Present at Evercore ISI 5th Annual Virtual HealthCONx Conference

Shares have lost nearly two-thirds of their value over the past 3 years. RTGel platform is a great fit for bladder cancers due to its ability to allow molecules to reside in the target space for an extended period of time.

UroGen Pharma: Jelmyto Sales Growing Steadily, Concerns Remain

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 highlights results from a retrospective multi-center study of 32 patients evaluating the safety of antegrade administration of JELMYTO (mitomycin) for pyelocalyceal solution via percutaneous nephrostomy tube for the treatment of patients with upper tract urothelial carcinoma (UTUC). The study titled, “Antegrade Administration of Mitomycin Gel for UTUC via Percutaneous Nephrostomy Tube: A Multi-Institutional Retrospective Cohort Study,” provides additional real-world evidence of a favorable safety and tolerability profile for JELMYTO when administered via percutaneous nephrostomy tube and is published in The British Journal of Urology International, November Issue.

UroGen Highlights New Real-World Safety Data Published in The British Journal of Urology International That Showed a Low Rate of Ureteral Stenosis When Antegrade Administration of JELMYTO® was Used in Patients with Upper Tract Urothelial Carcinoma

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