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 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 c.

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

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 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.

Long-Term Follow-up Study to the OLYMPUS Trial Presented at SUO 2024 Reports Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®

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 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.

UGN-102 Showed Promising Long-Term Results in the Phase 3 ENVISION Trial, Potentially Paving the Way for First FDA-Approved Treatment for LG-IR-NMIBC

The mean of analysts' price targets for Urogen Pharma (URGN) points to a 209.9% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Believe Urogen Pharma (URGN) Could Rally 209.92%: Here's is How to Trade

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 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 –.

UroGen Announces New Data Presentations at the Society of Urologic Oncology 2024 Annual Meeting Highlighting Urothelial Cancer Portfolio Aimed at Addressing Unmet Needs

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 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 primar.

New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO®

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Urogen's UGN-102 for bladder cancer presents a $5 billion market opportunity, prompting a continued "Strong Buy" rating despite past misjudgments. FDA approval by 06/2025 is crucial, with UGN-102 potentially being the first FDA-approved treatment for low-grade intermediate-risk NMIBC. Urogen's financials show a cash runway of over 2 years, with additional borrowing contingent on timely FDA approval.

UroGen Pharma: Choice Based On Near Term High Value PDUFA

UroGen Pharma Ltd. (NASDAQ:URGN ) Q3 2024 Earnings Call Transcript November 6, 2024 10:00 AM ET Company Participants Vincent Perrone - Head of IR Liz Barrett - President and CEO Mark Schoenberg - CMO David Lin - CCO Chris Degnan - CFO Conference Call Participants Tara Bancroft - TD Cowen Ram Selvaraju - H.

UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript

Urogen Pharma (URGN) came out with a quarterly loss of $0.55 per share versus the Zacks Consensus Estimate of a loss of $0.84. This compares to loss of $0.68 per share a year ago.

Urogen Pharma (URGN) Reports Q3 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 third quarter ended September 30, 2024, and provided an overview of recent developments. “The recent FDA acceptance of our New Drug Application for UGN-102 marks a significant milestone in our mission to deliver breakthrough treatments to patients,” said Liz B.

UroGen Pharma Reports 2024 Third Quarter Financial Results and Business Highlights, Including the Potential Launch of UGN-102 in 2025

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 Guggenheim Securities Healthcare Innovation Conference to take place November 11-13, 2024. Guggenheim Securities Healthcare Innovation Conference Date / Time: November 12, 2024 at 3:00 PM ET Format: Fireside Chat and 1x1 investo.

UroGen Pharma to Present at the Guggenheim Securities Healthcare Innovation Conference

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 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. A live public webcast of the earnings conference call c.

UroGen Pharma to Report Third Quarter Financial Results on Wednesday, November 6, 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 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. In ENVISION, UGN-102 treatmen.

ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially 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 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.

UroGen Announces FDA Acceptance of its New Drug Application for 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 Chris Degnan has been appointed Chief Financial Officer. Mr. Degnan succeeds Don Kim, who is leaving UroGen to pursue other opportunities. "Under Don's financial stewardship, we have strengthened our financial position and achieved significant milestones, which include multiple ca.

UroGen Appoints Chris Degnan as Chief Financial 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 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 mito.

First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Announces Patent Allowance.

UroGen Receives New U.S. Patent Allowance for Next-Generation Mitomycin-Based Products Expected to Provide Protection Until December 2041

UroGen Pharma stock is a strong buy due to its innovative RTGel technology and promising pipeline, including JELMYTO and UGN-102, targeting urological cancers. URGN's JELMYTO shows impressive clinical results with a 58% complete response rate for low-grade upper tract urothelial cancer, demonstrating long-lasting effects. URGN's diverse pipeline, including UGN-301 for high-grade NMIBC, positions the company for significant market expansion in urological cancer treatments.

UroGen Pharma's JELMYTO And UGN-102: A Strong Buy In The Urological Cancer Sector

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 fireside chats at the following investor conferences in September: H.C. Wainwright 26th Annual Global Investment Conference – September 9-11th, 2024 Fireside Chat: September 9th, 2024 at 9:00am ET Location: New York, NY Webcast Registration Link: Here 2024 C.

UroGen Pharma to Present at Upcoming Investor Conferences

PRINCETON, N.J.--(BUSINESS WIRE)--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 Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

UroGen Pharma Ltd. (NASDAQ:URGN ) Q2 2024 Earnings Call August 13, 2024 10:00 AM ET Company Participants Vincent Perrone - Head, Investor Relations Liz Barrett - President and Chief Executive Officer Mark Schoenberg - Chief Medical Officer David Lin - Chief Commercial Officer Dong Kim - Chief Financial Officer Conference Call Participants Tara Bancroft - TD Cowen Raghuram Selvaraju - H.C.

UroGen Pharma Ltd. (URGN) Q2 2024 Earnings Call Transcript

Urogen Pharma (URGN) came out with a quarterly loss of $0.91 per share versus the Zacks Consensus Estimate of a loss of $0.82. This compares to loss of $1.03 per share a year ago.

Urogen Pharma (URGN) Reports Q2 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 second quarter ended June 30, 2024, and provided an overview of recent developments. “Our immediate priority is completing the submission of a New Drug Application in the very near term for UGN-102, which we believe has the potential to be a practice-changing.

UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission and Reports 2024 Second 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 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. A live public webcast of the earnings conference call ca.

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