Subgroup analysis of the UGN-102 ATLAS Trial in patients with new versus recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Three independent long-term real-world analyses of JELMYTO® (mitomycin) for pyelocalyceal solution exploring its use in broad patient types and method of administration PRINCETON, N.J. / Apr 17, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech... Read More

UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024 Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041 PRINCETON, N.J. / Apr 15, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq:... Read More

PRINCETON, N.J. / Apr 03, 2024 / 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... Read More

Initiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission Announced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs from medac GmbH licensing agreement with potential IP protection until December 2041 JELMYTO ® achieved net product revenues of $82.7 million in 2023, an increase... Read More

PRINCETON, N.J. / Mar 08, 2024 / 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 12 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of... Read More

Conference Call and Webcast Scheduled for Thursday, March 14, 2024, at 10:00 AM ET PRINCETON, N.J. / Mar 04, 2024 / 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... Read More

Presentation March 4, 2024 at 1:30 PM ET PRINCETON, N.J. / Feb 26, 2024 / 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 44 th Annual Health Care Conference on Monday, March 4, 2024 at 1:30pm EST. TD Cowen 44 th Annual Health Care Conference –... Read More

Guggenheim 6th Annual Biotechnology Conference Oppenheimer 34th Annual Healthcare Life Sciences Conference PRINCETON, N.J. / Feb 01, 2024 / 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 February: Guggenheim 6th Annual... Read More

PRINCETON, N.J. / Jan 24, 2024 / 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... Read More

PRINCETON, N.J. / Jan 17, 2024 / 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 a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers. UGN-103, UroGen’s RTGel ® technology combined with medac’s licensed mitomycin,... Read More

Fireside Chat January 18, 2024, at 12:00 pm ET PRINCETON, N.J. / Jan 11, 2024 / 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 18 th... Read More

PRINCETON, N.J. / Dec 08, 2023 / 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 17 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of... Read More

Continued strong growth with JELMYTO® net product revenues of $20.9 million in Q3 2023; an increase of ~30% from the same period last year Agreement with United States Food & Drug Administration (FDA) to proceed with rolling New Drug Application (NDA) for UGN-102 beginning in January 2024 Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J. / Nov 14, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq:... Read More

Results from the pivotal Phase 3 ENVISION trial studying primary chemoablation with UGN-102 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) will be presented as a late-breaking oral presentation The Phase 3 ATLAS trial comparing the efficacy and safety of intravesical chemoablation with UGN-102 with or without subsequent TURBT, to... Read More

Conference Call and Webcast Scheduled for Tuesday, November 14, 2023 at 10:00 AM ET PRINCETON, N.J. / Nov 07, 2023 / 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... Read More

PRINCETON, N.J. / Oct 03, 2023 / 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... Read More

PRINCETON, N.J. / Sep 08, 2023 / 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 11 new employees, as well as options (“Options”) to one of the new employees, in connection with their employment with UroGen. These new... Read More

PRINCETON, N.J. / Aug 31, 2023 / 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 present at the following investor conferences in September: H.C. Wainwright 25th Annual Global Investment Conference — September 11-13, 2023 Presentation: Tuesday, September 12 th at 10:00 AM... Read More

Both ENVISION and ATLAS Phase 3 trials of UGN-102 met primary endpoints in treating low-grade intermediate-risk non‐muscle‐invasive bladder cancer (LG-IR-NMIBC). Reported record JELMYTO® net product revenues in Q2 2023 of $21.1 million, an increase of ~27% from the same period last year Significantly strengthened balance sheet via $120 million private placement of ordinary shares and pre-funded warrants PRINCETON, N.J. / Aug... Read More

Phase 3 ATLAS Clinical Trial Shows UGN-102 Demonstrated Superiority to TURBT with a 55% Reduction of Risk for Recurrence, Progression or Death in Patients who Received UGN-102 PRINCETON, N.J. / Aug 08, 2023 / 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... Read More

Conference Call and Webcast Scheduled for Thursday, August 10, 2023 at 10:00 AM ET PRINCETON, N.J. / Aug 02, 2023 / 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... Read More

PRINCETON, N.J. / Jul 31, 2023 / 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”) and options (“Options”) to a new employee, Michael Louie, SVP Medical Affairs & Clinical Development, in connection with his commencing... Read More

PRINCETON, N.J. / Jul 27, 2023 / 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... Read More

In ATLAS, UGN-102 Demonstrated Superiority to TURBT with a 55% Reduction of Risk for Recurrence, Progression or Death in Patients who Received UGN-102 ENVISION Showed a Complete Response Rate of 79.2% at 3-Months Side Effect Profile in ATLAS and ENVISION Consistent with Previous Clinical Trials of UGN-102 UroGen Will Review ATLAS and ENVISION Top-line Data Today at 10:00 a.m. Eastern Time PRINCETON, N.J. / Jul 27, 2023 /... Read More

PRINCETON, N.J. / Jul 25, 2023 / 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... Read More

PRINCETON, N.J. / Jul 10, 2023 / 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... Read More

Program to Highlight Topline Results from the Phase 3 ATLAS and Pivotal ENVISION Clinical Trials PRINCETON, N.J. / Jul 06, 2023 / 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... Read More

PRINCETON, N.J. / Jun 20, 2023 / 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... Read More

PRINCETON, N.J. / Jun 09, 2023 / 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... Read More

PRINCETON, N.J. / Jun 02, 2023 / 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 June: Jefferies 2023 Healthcare Conference — June 7-9, 2023 Fireside Chat Date: Friday, June 9 th from 12:45-1:10pm ET Webcast Link:... Read More

Reported JELMYTO ® Q1 2023 net product revenues of $17.2 million, an increase of ~27% from Q1 2022 Complete Response data from ENVISION pivotal trial and topline data readout from ATLAS trial on track for summer 2023 PRINCETON, N.J. / May 11, 2023 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers,... Read More

Conference Call and Webcast Scheduled for Thursday, May 11, 2023, at 10:00 AM ET PRINCETON, N.J. / May 04, 2023 / 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... Read More

New Retrospective Study Presented at AUA 2023 Reports Use of JELMYTO in Treating Patients with Upper Tract Urothelial Cancer After Complete Endoscopic Ablation PRINCETON, N.J. / May 01, 2023 / 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... Read More

PRINCTON, N.J. / Apr 30, 2023 / 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... Read More

Fireside Chat May 2, 2023 from 10:00 – 10:30 AM ET PRINCETON, N.J. / Apr 25, 2023 / 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... Read More

PRINCETON, N.J. / Mar 09, 2023 / 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... Read More

PRINCETON, N.J. / Mar 06, 2023 / 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 7 new employees in connection with their entering into employment with UroGen. The grants were made between March 1, 2023 and March 6, 2023.... Read More

PRINCETON, N.J. / Mar 01, 2023 / 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 March: Cowen 43 rd Annual Health Care Conference — March 7-9, 2023 Panel Presentation Date: Tuesday, March 7 th from 12:50-1:50pm ET... Read More

PRINCETON, N.J. / Feb 15, 2023 / 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... Read More

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... Read More

Results from this ongoing, non-interventional, rollover study were presented at the 23 rd Annual Society of Urologic Oncology (SUO) Meeting in San Diego 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... Read More