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 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). "The submission of the CMC portion of the NDA for UGN-102 marks a significant milest.

UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers.

UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial 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 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. To access the event, please RSVP to your B. Riley Securities sales representative. Following the event, a replay o.

UroGen Pharma to Participate in the B. Riley Healthcare Conference

Urogen Pharma Ltd (URGN) Q3 2023 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 third quarter ended September 30, 2023, and provided an overview of recent developments. “During the third quarter, UroGen achieved several notable milestones, including announcement of unprecedented positive results from our ENVISION and ATLAS Phase 3 trials.

UroGen Pharma Reports Third Quarter 2023 Financial Results

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, 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 commer.

UroGen will Present Scientific Advances in Bladder Cancer at the Annual Meeting of the Society of Urologic Oncology

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 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. A live public webcast of the earnings conference call.

UroGen Pharma to Report Third Quarter 2023 Financial Results on Tuesday, November 14, 2023

UroGen Pharma shows promising clinical data for UGN-102 and solid financials, despite operational losses. Institutional activity and stock performance signal cautious optimism, suggesting the company's disruptive potential. Investment Recommendation: "Buy" status is justified given strong clinical milestones and financial health, despite existing risks.

UroGen Pharma's Financial And Clinical Symbiosis

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 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 du.

Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024

This jump in UroGen's (URGN) stock price is attributable to positive data from two late-stage studies on bladder cancer therapy. An FDA filing for the candidate is expected next year.

UroGen Pharma (URGN) Stock Surges 89% in a Month: Here's Why

UroGen Pharma Ltd. (NASDAQ:URGN ) Q2 2023 Results Conference Call August 10, 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 Raghuram Selvaraju - H.C.

UroGen Pharma Ltd. (URGN) Q2 2023 Earnings Call Transcript

The consensus price target hints at an 89.6% upside potential for Urogen Pharma (URGN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Think Urogen Pharma (URGN) Could Surge 89.61%: Read This Before Placing a Bet

Urogen Pharma (URGN) came out with a quarterly loss of $1.03 per share versus the Zacks Consensus Estimate of a loss of $1.13. This compares to loss of $1.18 per share a year ago.

Urogen Pharma (URGN) Reports Q2 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 second quarter ended June 30, 2023, and provided an overview of recent developments. “We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma. “Recently, we announced positive topline results from.

UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

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 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 rese.

The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment 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 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. A live public webcast of the earnings conference call can be.

UroGen Pharma to Report Second Quarter 2023 Financial Results on Thursday, August 10, 2023

UroGen also announced a $120 million private placement to raise funds. The company said it could have its second marketed product as early as next year.

Why Shares of UroGen Pharma Jumped Friday

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

UroGen Announces $120 Million Private Placement of Ordinary Shares

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 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. In the ATLAS tr.

UGN-102, in Development as the Potential First Non-Surgical Therapy for LG-IR-NMIBC, Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials

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 James Robinson, former President and Chief Executive Officer (CEO) of Urovant Sciences, to its Board of Directors, effective immediately. “We are thrilled to welcome Jim to the Board of Directors,” said Liz Barrett, President and Chief Executive Officer of UroGen. “His pr.

UroGen Pharma Announces the Appointment of James Robinson to its 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 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.

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