Urogen Pharma Ltd (OQ:URGN)

Business Focus: Bio Therapeutic Drugs

Apr 17, 2024 12:02 pm ET

UroGen Announces New Data Presentations at the American Urological Association 2024 Annual Meeting Highlighting Clinical Benefits of Our Portfolio for Urothelial Cancers

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 investigational drug UGN-102 (mitomycin) and JELMYTO and will be presented at the American Urological Association (AUA) 2024 Annual Meeting being held in San Antonio, Texas from May 3 – 6.

Apr 15, 2024 08:00 am ET

UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Apr 03, 2024 08:00 am ET

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

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 infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”). Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equival

Mar 14, 2024 08:00 am ET

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Mar 08, 2024 08:00 am ET

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

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 Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Mar 04, 2024 08:00 am ET

UroGen Pharma to Report Fourth Quarter and Full-Year 2023 Financial Results on Thursday, March 14, 2024

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 open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

Feb 26, 2024 08:00 am ET

UroGen Pharma to Present at TD Cowen 44th Annual Health Care Conference

Feb 01, 2024 08:00 am ET

UroGen Pharma to Participate at Upcoming Investor Conferences

Jan 24, 2024 08:00 am ET

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

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).

Jan 17, 2024 08:00 am ET

UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers

Jan 11, 2024 08:00 am ET

UroGen Pharma to Participate in the B. Riley Healthcare Conference

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.

Dec 08, 2023 04:00 pm ET

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

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 Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Nov 14, 2023 08:00 am ET

UroGen Pharma Reports Third Quarter 2023 Financial Results

Nov 13, 2023 08:00 am ET

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

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 commercializing innovative treatments for urothelial and specialty cancers that provide patients with novel non-surgical options to fulfill t

Nov 07, 2023 08:00 am ET

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

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.

Oct 26, 2023 09:31 am ET

Thinking about buying stock in Kosmos Energy, AGNC Investment, Urogen Pharma, Jaguar Global Growth Corporation, or Endeavor Group?

NEW YORK, Oct. 26, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for KOS, AGNC, URGN, JGGC, and EDR.

Oct 03, 2023 08:00 am ET

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

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 duration of complete response (CR) at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of l

Sep 11, 2023 07:00 am ET

Eledon Pharmaceuticals Appoints Industry Veteran James Robinson to its Board of Directors

Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of James Robinson to its Board of Directors effective October 1, 2023. Mr. Robinson is a seasoned biopharmaceutical executive with over 30 years of experience in...

Sep 08, 2023 08:00 am ET

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

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 team members will support the ongoing commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Aug 31, 2023 08:00 am ET

UroGen Pharma to Present at Upcoming Investor Conferences

Aug 10, 2023 08:00 am ET

UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

Aug 08, 2023 08:00 am ET

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

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 resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who

Aug 02, 2023 05:00 pm ET

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

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.

Jul 31, 2023 08:00 am ET

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

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 employment with UroGen.

Jul 27, 2023 09:55 am ET

UroGen Announces $120 Million Private Placement of Ordinary Shares

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 included Acorn Bioventures, Monograph Capital and Horton Capital Partners Fund, LP. UroGen expects to receive gross proceeds of approxi

Jul 27, 2023 09:50 am ET

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

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.

Jul 25, 2023 04:10 pm ET

UroGen Pharma Announces the Appointment of James Robinson to its Board of Directors

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.

Jul 10, 2023 08:00 am ET

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

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 mechanical ablation or renal preservation. Findings from the study titled, The Ablative Effect of Mitomycin Reverse Thermal Gel: Expand

Jul 06, 2023 08:00 am ET

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

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 from the Phase 3 ATLAS and ENVISION clinical trials.

Jun 20, 2023 08:00 am ET

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

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 adult patients. Findings from the study titled, Route of Administration for UGN-101 and Impact on Oncological and Safety Ou

Jun 09, 2023 08:00 am ET

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

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 continued development of the Company’s pipeline.

Jun 02, 2023 08:00 am ET

UroGen Pharma to Present at Upcoming Investor Conferences

May 11, 2023 08:00 am ET

UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments

May 04, 2023 08:00 am ET

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

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.

May 01, 2023 02:00 pm ET

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

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 (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma Early Experience w

Apr 30, 2023 08:00 am ET

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

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 UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tum

Apr 25, 2023 08:00 am ET

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

Mar 16, 2023 08:00 am ET

UroGen Pharma Reports Highest Revenue Quarter and Significant Full Year 2022 Growth and Recent Corporate Developments

Mar 09, 2023 04:00 pm ET

UroGen Pharma to Report Fourth Quarter and Full-Year 2022 Financial Results on Thursday, March 16, 2023

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.

Mar 06, 2023 08:00 am ET

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

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. These new team members will support the ongoing commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Mar 01, 2023 04:00 pm ET

UroGen Pharma to Present at Upcoming Investor Conferences

Feb 15, 2023 09:06 am ET

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

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). In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75%

Jan 11, 2023 08:00 am ET

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

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 Uroth

Dec 19, 2022 08:00 am ET

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)

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.

Dec 09, 2022 08:00 am ET

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

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 commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Dec 02, 2022 12:00 pm ET

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, Intermedia

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.

Dec 01, 2022 07:00 pm ET

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 Tr

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.

Nov 21, 2022 04:00 pm ET

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

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.

Nov 14, 2022 08:00 am ET

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

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 Retrospect

Nov 10, 2022 08:00 am ET

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

Nov 09, 2022 08:00 am ET

UroGen Announces the Appointment of Dan Wildman to the UroGen Pharma Board of Directors

Nov 03, 2022 08:00 am ET

UroGen Pharma to Report Third Quarter 2022 Financial Results on Thursday, November 10, 2022

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 2022 financial results on Thursday, November 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.

Oct 11, 2022 08:00 am ET

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

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.

Sep 28, 2022 08:00 am ET

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

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 for all stakeholders including physicians, hospitals, pharmacists and the adult patients who use UroGen’s medicine to treat lo

Sep 12, 2022 08:00 am ET

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

Sep 09, 2022 08:00 am ET

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

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 10 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 continued development of the Company’s pipeline.

Sep 07, 2022 04:00 pm ET

UroGen Pharma Announces Upcoming 2022 Conferences

Aug 11, 2022 08:00 am ET

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

Jul 27, 2022 08:00 am ET

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

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.

Jun 03, 2022 08:00 am ET

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

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 16 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 continued development of the Company’s pipeline.

May 18, 2022 08:00 am ET

UroGen Pharma to Present at Upcoming Investor Conferences

May 16, 2022 02:50 pm ET

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

“JELMYTO is efficacious as a chemoablative agent in adult patients with low grade upper tract urothelial cancer, and while it’s FDA approved for both antegrade and retrograde administration, prior reports are limited to the retrograde experience,” said Kyle Rose, MD, Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla., and study investigator. “These data provide additional evidence that instillation via a nephrostomy tube is an effective instillation method with a safety profile that offers an encouraging option to appropriate patients.”

May 13, 2022 08:00 am ET

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

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 Urological Association (AUA) Annual Meeting, May 13-16 in New Orleans, Louisiana. The presentations will be published in the June 2022 i

May 10, 2022 09:00 am ET

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

May 10, 2022 08:00 am ET

Phathom Pharmaceuticals Reports First Quarter 2022 Results and Provides Recent Clinical, Regulatory, and Business Updates

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the first quarter of 2022 and provided updates...

May 03, 2022 08:00 am ET

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

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.

Mar 29, 2022 08:00 am ET

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. (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 start in April and support the development of UGN-301 in high-grade (HG) NMIBC.

Mar 22, 2022 08:02 am ET

Phathom Pharmaceuticals Announces Appointment of Molly Henderson as Chief Financial and Business Officer

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced the appointment of Molly Henderson to the...

Mar 21, 2022 08:00 am ET

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

Mar 08, 2022 08:00 am ET

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

Mar 04, 2022 04:30 pm ET

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

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 commercial launch of Jelmyto® (mitomycin) for pyelocalyceal solution, UroGen’s first approved product, and the continued development of the Company’s pipeline.

Mar 04, 2022 03:00 pm ET

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

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.

Mar 01, 2022 08:00 am ET

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

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 second quarter of 2022 and will evaluate the safety and tolerability of UGN-301 as monotherapy and in combination with other immunomodulator

Feb 28, 2022 08:00 am ET

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

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.

Feb 10, 2022 08:00 am ET

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

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) from initial ureteroscopy to nephrostomy placement, Jelmyto administration, and eventual nephrostomy removal.

Feb 03, 2022 08:00 am ET

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

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).

Jan 05, 2022 08:00 am ET

UroGen Pharma to Present at Upcoming Conferences

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:

Dec 21, 2021 08:00 am ET

First Patient Dosed in UroGen Pharma’s Home Instillation Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Dec 03, 2021 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the grants of inducement restricted stock units (“RSUs”) to 13 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 continued development of the Company’s pipeline.

Nov 15, 2021 08:00 am ET

UroGen Pharma Reports Third Quarter 2021 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2021, and provided an overview of the Company’s recent developments.

Nov 11, 2021 08:00 am ET

UroGen Pharma Announces Upcoming 2021 Conferences

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 November:

Nov 10, 2021 11:00 am ET

UroGen Pharma Unveils New Phase 3 Development Plan for UGN-102 at Spotlight Event

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, is announcing at its virtual Spotlight Event being held today that, following recent discussions with the U.S. Food and Drug Administration (“FDA”), it plans to conduct a new, single-arm Phase 3 pivotal study of UGN-102 for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer (“NMIBC”). This new study, which is expected to initiate in early 2022, is expected to enroll approximately 220 patients across

Nov 01, 2021 08:00 am ET

UroGen Pharma to Host Virtual Spotlight Event on November 10, 2021

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will host a virtual “Spotlight Event” on Wednesday, November 10, 2021 at 11:00 a.m. Eastern Time. The event will focus on UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC), and the Company’s earlier-stage clinical programs including UGN-301 and UGN-302.

Oct 05, 2021 08:00 am ET

The Journal of Urology Publishes Results of UroGen Pharma’s Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)

UroGen Pharma Ltd. (Nasdaq: URGN) today announced The Journal of Urology® published results from the Phase 2b OPTIMA II trial, a Phase 2b, open-label, single-arm trial studying UGN-102 (mitomycin) for intravesical solution as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was published

Sep 23, 2021 08:00 am ET

UroGen Pharma to Present at the 2021 Cantor Virtual Global Healthcare Conference

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will present at the Cantor Fitzgerald 2021 Virtual Global Healthcare Conference on Thursday, September 30, 2021, at 3:20 p.m. Eastern Time.

Sep 13, 2021 08:00 am ET

UroGen Pharma Presents Data Showcasing Novel Clinical Data at 2021 American Urological Association (AUA) Annual Meeting

UroGen Pharma Ltd. (Nasdaq: URGN) today announced final data from two key trials, evaluating the safety and efficacy of investigational agent UGN-102 (mitomycin) for intravesical solution in adult patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC) and Jelmyto® (mitomycin) for pyelocalyceal solution in adult patients with low-grade upper tract urothelial cancer (LG-UTUC). The results were presented at the virtual 2021 American Urological Association (AUA) Annual Meeting and published as a supplement to the September 10, 2021 issue of

Sep 10, 2021 08:00 am ET

UroGen Pharma to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand via the conference portal and through the Investors section of UroGen’s website,

Sep 03, 2021 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the grants of inducement restricted stock units (“RSUs”) to 19 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 continued development of the Company’s pipeline.

Aug 04, 2021 08:00 am ET

UroGen Pharma Reports Second Quarter 2021 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the second quarter ended June 30, 2021, and provided an overview of the Company’s recent developments.

Aug 02, 2021 08:30 am ET

Allogene Therapeutics Appoints Industry Leaders Elizabeth (Liz) Barrett and Vicki Sato, Ph.D., to its Board of Directors

Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced the appointment of Elizabeth (Liz) Barrett and Vicki Sato, Ph.D. to...

Jul 28, 2021 04:00 pm ET

UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and Neopharm group (“Neopharm”), today announced an exclusive license for Neopharm to market and sell Jelmyto® (mitomycin) for pyelocalyceal solution in Israel, subject to regulatory approval. Jelmyto is the first and only U.S. Food and Drug Administration approved medicine for adult patients with low-grade upper tract urothelial cancer (LG-UTUC).

Jul 28, 2021 08:00 am ET

UroGen Pharma to Report Second Quarter 2021 Financial Results on Wednesday, August 4, 2021

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

Jul 14, 2021 08:00 am ET

UroGen Pharma Reports Strong Preliminary Jelmyto® Sales for Second Quarter 2021

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it expects net product revenue from Jelmyto sales for the second quarter ended June 30, 2021, to be approximately $13.0 million, representing an increase of over 70% compared to the first quarter of 2021 and the highest quarterly sales since Jelmyto was launched in June 2020. Additionally, operating expenses in the second quarter of 2021 are anticipated to be in the range of $33 to $38 million. Cash, ca

Jul 07, 2021 08:00 am ET

UroGen Pharma to Present at Ladenburg Thalmann Healthcare Conference

UroGen Pharma Ltd (Nasdaq:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will present at the Ladenburg Thalmann Healthcare Conference on July 14, 2021 at 12:00pm Eastern Time.

Jun 04, 2021 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the grants of inducement restricted stock units (“RSUs”) to eleven 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 continued development of the Company’s pipeline.

May 25, 2021 08:00 am ET

UroGen Pharma Announces June 2021 Conference Schedule

May 13, 2021 07:30 am ET

UroGen Pharma Reports First Quarter 2021 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the first quarter ended March 31, 2021 and provided an overview of the Company’s recent developments.

May 06, 2021 08:00 am ET

UroGen Pharma to Report First Quarter 2021 Financial Results on Thursday, May 13, 2021

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will report first quarter 2021 financial results on Thursday, May 13, 2021, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

Mar 18, 2021 08:00 am ET

UroGen Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the fourth quarter and full year ended December 31, 2020 and provided an overview of the Company’s recent developments.

Mar 18, 2021 07:30 am ET

UroGen Pharma Announces $75 Million of Non-Dilutive Funding from RTW Investments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that the Company has entered into a strategic funding agreement with RTW Investments, LP and its affiliated entities (“RTW”).

Mar 15, 2021 08:00 am ET

UroGen Pharma Announces Sponsored Research Agreement with the Johns Hopkins University School of Medicine to Expand Immuno-Oncology Pipeline

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced a strategic, exploratory immunotherapy sponsored research agreement with the Johns Hopkins University to study the potential of checkpoint inhibitors combined with RTGel™ in glioblastoma multiforme, or GBM, an aggressive and difficult to treat brain cancer. Johns Hopkins researchers expect to begin nonclinical research of RTGel combined with a PD-1 and a CTLA-4, respectively, in the second quarter

Mar 11, 2021 08:00 am ET

UroGen Pharma to Report Fourth Quarter and Full Year 2020 Financial Results on Thursday, March 18, 2021

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will report fourth quarter and full year 2020 financial results on Thursday, March 18, 2021, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

Mar 05, 2021 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the grants of inducement restricted stock units (“RSUs”) to nine 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 continued development of the Company’s pipeline.

Feb 23, 2021 08:00 am ET

UroGen Pharma Announces March 2021 Conference Schedule

Jan 13, 2021 08:00 am ET

UroGen Pharma and MD Anderson Announce Strategic Research Collaboration to Advance Investigational Treatment for High-Grade Bladder Cancer

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, and The University of Texas MD Anderson Cancer Center today announced a strategic three-year collaboration agreement to advance combinatorial intra

Jan 06, 2021 08:00 am ET

UroGen Pharma to Present at the Virtual 39th Annual J.P. Morgan Healthcare Conference

UroGen Pharma Ltd. (Nasdaq:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that Liz Barrett, President and Chief Executive Officer, will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 4:30 p.m. Eastern Time.

Dec 04, 2020 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the grants of inducement restricted stock units (“RSUs”) to nine 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 continued development of the Company’s pipeline.

Dec 03, 2020 08:00 am ET

UroGen Pharma Announces Podium Presentation of Final Jelmyto® Data From Pivotal OLYMPUS Trial at the Annual Meeting of the Society of Urologic Oncology

UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the presentation of final data from the UGN-101 Jelmyto® (mitomycin) for pyelocalyceal solution Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC). The results will be presented as a virtual podium presentation at the 21st Annual Meeting of the Society of Urologic Oncology (SUO):

Nov 17, 2020 08:00 am ET

Complete and Durable Responses Observed in OPTIMA II Phase 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

UroGen Pharma Ltd. (Nasdaq: URGN) today announced final topline results from the single-arm, open-label OPTIMA II Phase 2b trial evaluating the efficacy and safety of investigational UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy. In this subset of patients, duration of response at nine months (12-months from start of therapy) was estimated by Kaplan-Meier analysi

Nov 11, 2020 08:00 am ET

Centers for Medicare & Medicaid Services (CMS) Issues Permanent J-Code for UroGen’s Jelmyto® Effective January 1, 2021

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that the Centers for Medicare & Medicaid Services (CMS) has established a permanent and product-specific J-code for Jelmyto® (mitomycin) for pyelocalyceal solution that will take effect on January 1, 2021. The J-code is expected to replace the previously issued temporary C-code and will standardize and facilitate reimbursement in the hospital outpatient, ambulatory surgery center and physician off

Nov 10, 2020 08:00 am ET

UroGen Pharma Announces November 2020 Conference Schedule

Nov 09, 2020 08:00 am ET

UroGen Pharma Reports Third Quarter 2020 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the third quarter ended September 30, 2020 and provided an overview of the Company’s recent developments.

Nov 02, 2020 08:00 am ET

UroGen Pharma to Report Third Quarter 2020 Financial Results on Monday, November 9, 2020

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that it will report third quarter 2020 financial results on Monday, November 9, 2020, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

Oct 05, 2020 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq:URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced that, on October 1, 2020, the Compensation Committee of its Board of Directors granted inducement stock options to purchase up to an aggregate of 170,000 ordinary shares (the “Options”) and 70,700 restricted stock units (“RSUs”) to eight new employees in connection with their employment with UroGen. These new team members will support the ongoing commercial launch of the Company’s first pr

Sep 10, 2020 08:00 am ET

UroGen Pharma Announces September 2020 Conference Schedule

Sep 09, 2020 08:00 am ET

UroGen Pharma Expands Executive Team to Accelerate Platform Innovation and Drive Commercial Growth

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced the appointment of three new executives to the Company's Executive Leadership Team (ELT). These new hires, all of whom will report to Liz Barrett, President and Chief Executive Officer of UroGen, bring a breadth of experience to help execute the Company's business objectives in the near-term and its growth strategies for the long-term in support of pipeline development, RTGel™ platform expansion, access to e

Sep 04, 2020 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq: URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced the grants of inducement restricted stock units (“RSUs”) to nineteen new employees in connection with their employment with UroGen. These new team members will support the ongoing Commercial launch of the Company’s first product and the continued development of UroGen’s pipeline.

Aug 27, 2020 08:00 am ET

UroGen Pharma Announces Update on the Phase 2 Trial of an RTGel™ Hydrogel Formulation in Combination with BOTOX® (onabotulinumtoxinA) Intravesical Instillation for Overactive Bladder and Urinary Incon

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that the Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with BOTOX® (onabotulinumtoxinA) intravesical instillation in patients with overactive bladder (OAB) and urinary incontinence did not meet the primary endpoint of improvement of overactive bladder symptoms, as measured by the reduction in urinary incontinence episodes per day. Data suggests that this result may h

Aug 10, 2020 08:00 am ET

UroGen Pharma Reports Second Quarter 2020 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the second quarter ended June 30, 2020 and provided an overview of the Company’s recent developments.

Aug 03, 2020 08:00 am ET

UroGen Pharma to Report Second Quarter 2020 Financial Results on Monday, August 10, 2020

UroGen Pharma Ltd. (Nasdaq:URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases, today announced that it will report second quarter 2020 financial results on Monday, August 10, 2020, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

Jun 05, 2020 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced the grants of inducement restricted stock units (“RSUs”) on June 3, 2020 to eight new employees in connection with their employment with UroGen. These new team members will support the Company’s commercial launch of JelmytoTM (mitomycin) for pyelocalyceal solution, its first approved product.

Jun 01, 2020 08:00 am ET

UroGen Pharma to Present at Jefferies Virtual Healthcare Conference

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that Liz Barrett, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020, at 3:30 PM Eastern Time.

May 15, 2020 09:01 am ET

UroGen Pharma Announces First Presentation of Data from Phase 2b Study of UGN-102 in Patients with Difficult to Treat Type of Bladder Cancer

UroGen Pharma Ltd. (Nasdaq: URGN) today announced the presentation of positive interim data from the Phase 2b OPTIMA II trial evaluating the safety and efficacy of investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed vi

May 15, 2020 09:00 am ET

UroGen Announces Positive Data from Pivotal OLYMPUS Trial Evaluating Jelmyto™ in Patients with Low-Grade Upper Tract Urothelial Cancer

UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto™ (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website

May 07, 2020 08:00 am ET

UroGen Pharma Reports First Quarter 2020 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the first quarter ended March 31, 2020 and provided an overview of the Company’s recent developments.

May 01, 2020 08:00 am ET

UroGen Pharma to Report First Quarter 2020 Financial Results On Thursday, May 7, 2020

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced that it will report first quarter 2020 financial results on Thursday, May 7, 2020, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

Apr 30, 2020 08:00 am ET

The Lancet Oncology Publishes Details of UroGen Pharma’s Pivotal OLYMPUS Trial

UroGen Pharma Ltd. (Nasdaq: URGN) today announced The Lancet Oncology published results from the pivotal Phase 3 OLYMPUS trial, reporting that 59% of low-grade upper tract urothelial cancer (LG-UTUC) patients treated with UGN-101, now referred to as

Apr 15, 2020 06:22 pm ET

UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer

UroGen Pharma Ltd. (Nasdaq: URGN) today announced the U.S. Food and Drug Administration (FDA) granted expedited approval for Jelmyto™ (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). This landmark approval is based on positive results from the Phase 3 OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer.

Apr 03, 2020 08:00 am ET

UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). These data were featured in a late-breaking abstract published in the April Supplement to

Mar 23, 2020 08:00 am ET

UroGen Pharma Promotes Key Personnel Focused on Commercial Operations and Expanded Clinical Development

UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced promotions for key members of the Executive Leadership Team. These appointments will better position the Company for its next growth phase with the anticipated approval and launch of its first product candidate, UGN-101 (mitomycin gel) for instillation, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). In December 2019, the U.S. Food and Drug Administrati

Mar 06, 2020 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced the grants of inducement restricted stock units (“RSUs”) to seventy-six new employees in connection with their employment with Urogen. These new team members will support the Company as it prepares for potential approval and commercial launch of its first product candidate.

Mar 02, 2020 08:00 am ET

UroGen Pharma Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Corporate Developments

“At UroGen, we are eagerly awaiting potential approval of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The significant progress on key clinical, regulatory and commercial milestones in 2019 places us in a position of strength as we prepare to deliver the first non-surgical therapy for the treatment of LG UTUC. Our experienced commercial team has been working tirelessly to ensure we are prepared for launch, and we look forward to providing these patients with a new treatment option,” said Liz Barrett, President and Ch

Feb 25, 2020 08:00 am ET

UroGen Pharma Announces March 2020 Investor Conference Schedule

Feb 24, 2020 08:00 am ET

UroGen Pharma to Report Fourth Quarter and Full Year 2019 Financial Results on Monday, March 2, 2020

UroGen Pharma Ltd. (Nasdaq:URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced that it will report fourth quarter and full year 2019 financial results on Monday, March 2, 2020, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

Jan 08, 2020 08:00 am ET

UroGen to Present at 38th Annual J.P. Morgan Healthcare Conference

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, today announced that Liz Barrett, President and Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 1:30 PM Pacific Time. The event will be held in San Francisco at the Westin St. Francis.

Dec 19, 2019 08:00 am ET

UroGen Pharma Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101

UroGen Pharma Ltd. (Nasdaq: URGN) today announced the U.S. Food and Drug Administration (FDA) accepted for filing and granted priority review for its New Drug Application (NDA) for UGN-101 (mitomycin gel) for instillation as a potential treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). If approved, UGN-101 would be the first non-surgical treatment option for LG UTUC.

Dec 06, 2019 08:00 am ET

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

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced the grants of inducement restricted stock units (“RSUs”) to five new employees in connection with their employment with Urogen. These new team members will support pre-launch activities and infrastructure buildout as the Company prepares for potential approval and commercial launch of its first product candidate.

Nov 18, 2019 08:00 am ET

UroGen to Present at November 2019 Investor Conferences

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced that it will participate in fireside chats at the following conferences in November:

Nov 12, 2019 08:00 am ET

UroGen Pharma Reports Third Quarter 2019 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced financial results for the third quarter ended September 30, 2019 and provided an overview of the Company’s recent developments.

Nov 11, 2019 08:00 am ET

UroGen Pharma Announces Exclusive License Agreement with Agenus Inc to Advance Treatment of Urinary Tract Cancers

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, today announced that it has entered into an exclusive worldwide1 license agreement with Agenus Inc (Nasdaq:AGEN) to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) via intravesical delivery in combination with UGN-201 for the treatment of urinary tract cancers. This combination is based on encouraging preclinical data utilizing UroGen’s proprietary sustained release technology, which is designed to enable long

Nov 06, 2019 08:00 am ET

UroGen Pharma to Report Third Quarter 2019 Financial Results on Tuesday, November 12, 2019

UroGen Pharma Ltd. (Nasdaq:URGN) today announced that it will report third quarter 2019 financial results on Tuesday, November 12, 2019, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

Sep 30, 2019 08:00 am ET

UroGen To Present at October 2019 Investor Conference

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced that it will present at the following conference in October:

Sep 24, 2019 04:01 pm ET

UroGen Investor Day Details Positive Clinical Updates, UGN-101 Launch Preparedness, and Pipeline Advances

UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today presented updates on its advancing pipeline for urologic cancers and UGN-101 launch readiness at its Investor Day in New York on September 24, 2019.

Sep 24, 2019 10:25 am ET

UroGen Reports Positive Data from Two Important Studies: UGN-101 OLYMPUS Pivotal Trial in LG UTUC and UGN-102 Phase 2b OPTIMA II Trial in LG Bladder Cancer

UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, today announced updated findings from the UGN-101 Phase 3 OLYMPUS Trial in patients with low-grade upper tract urothelial cancer (LG UTUC), as well as initial CR data from the UGN-102 Phase 2b OPTIMA II Trial in patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC).

Sep 10, 2019 08:00 am ET

UroGen To Host Investor Day on September 24, 2019 Spotlighting Clinical Development Updates and UGN-101 Launch Readiness

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced that it will host an Investor Day on September 24, 2019 in New York where the Company will share updates on its clinical programs and launch readiness plans for UGN-101 (mitomycin gel) for instillation, its lead product candidate for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The program will also highlight the Company’s vision and strategy and include a panel discussion with key opinion leaders on the

Sep 06, 2019 04:05 pm ET

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

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced the grants of inducement restricted stock units (“RSUs”) to 15 new employees in connection with their employment with UroGen. These new team members in commercial and operational positions will support pre-launch activities and infrastructure buildout as the Company prepares for potential approval and commercial launch of its first product candidate.

Aug 09, 2019 08:00 am ET

UroGen Pharma Reports Second Quarter 2019 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent developments.

Aug 05, 2019 08:00 am ET

UroGen Pharma to Report Second Quarter 2019 Financial Results on Friday, August 9, 2019

Audio Webcast

Jul 01, 2019 08:00 am ET

UroGen Pharma Joins Russell 3000® Index

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced that it joined the broad-market Russell 3000® Index at the conclusion of the 2019 Russell indexes annual reconstitution, effective after the close of the US market on June 28, 2019.

May 30, 2019 08:00 am ET

UroGen Pharma to Present at June 2019 Investor Conferences

UroGen Pharma Ltd. (Nasdaq:URGN), today announced that management will present at three investor conferences in June:

May 09, 2019 08:00 am ET

UroGen Pharma Reports First Quarter 2019 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced financial results for the first quarter ended March 31, 2019 and provided an overview of the Company’s recent developments.

May 05, 2019 04:25 pm ET

UroGen Delivers Updated Complete Response (CR) and Durability Data from the UGN-101 Phase 3 OLYMPUS Trial

UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which showed that UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation, demonstrated a 59 percent complete response rate in a subset of patients with endoscopically unresectable low-grade upper tract urothelial cancer (UTUC). Findings were presented by Seth Paul Lerner, M.D., FACS,

May 02, 2019 08:00 am ET

UroGen Pharma to Report First Quarter 2019 Financial Results on Thursday, May 9, 2019

UroGen Pharma Ltd. (Nasdaq:URGN) today announced that it will report first quarter 2019 financial results on Thursday, May 9, 2019, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

Apr 23, 2019 08:00 am ET

UroGen Pharma Announces Early Stage Feasibility Agreement with Janssen

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, today announced that it has entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest. UroGen and Janssen will each conduct certain activities under the terms of the agreement.

Apr 16, 2019 08:45 am ET

New Research: Key Drivers of Growth for Ironwood Pharmaceuticals, State Street, CMS Energy, Virtus Investment Partners, Capstone Turbine, and UROGEN PHARMA — Factors of Influence, Major Initiatives an

In new independent research reports released early this morning, Capital Review released its latest key findings for all current investors, traders, and shareholders of Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), State Street Corporation...

Apr 05, 2019 09:12 am ET

UroGen Pharma Announces Presentation of Analysis from Phase 3 OLYMPUS Trial of UGN-101 for Patients with Low-Grade Upper Tract Urothelial Cancer

UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced a new presentation from the pivotal Phase 3 OLYMPUS trial of UGN-101 (mitomycin gel) for instillation, an investigational formulation for the primary non-surgical treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The analysis, which discusses the minimally invasive chemoablation approach of UGN-101 to potentially treat LG UTUC tumors, including those that are unres

Mar 05, 2019 08:00 am ET

UroGen Pharma to Present at March 2019 Investor Conferences

UroGen Pharma Ltd. (Nasdaq:URGN), today announced that management will present at two investor conferences in March:

Feb 28, 2019 08:00 am ET

UroGen Pharma to Report Fourth Quarter and Full Year 2018 Financial Results

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, today announced financial results for the fourth quarter and full year ended December 31, 2018 and provided an overview of the Company’s recent developments.

Feb 21, 2019 08:00 am ET

UroGen Pharma to Report Fourth Quarter and Full Year 2018 Financial Results on Thursday, February 28, 2019

UroGen Pharma Ltd. (Nasdaq:URGN) today announced that it will report fourth quarter and full year 2018 financial results on Thursday, February 28, 2019, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

Feb 19, 2019 08:15 am ET

Factors of Influence in 2019, Key Indicators and Opportunity within Toyota Motor, UROGEN PHARMA, Macerich, Cosan, Middlesex Water, and Howard Hughes — New Research Emphasizes Economic Growth

In new independent research reports released early this morning, Market Source Research released its latest key findings for all current investors, traders, and shareholders of Toyota Motor Corporation (NYSE:TM), UROGEN PHARMA (NASDAQ:URGN),...

Jan 28, 2019 04:05 pm ET

UroGen Pharma Announces Closing of Public Offering of Ordinary Shares and Full Exercise of Underwriters' Option to Purchase Additional Shares

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the closing of its previously announced public offering of 4,207,317 ordinary shares, including 548,780 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. All of the ordinary shares were sold at a price to the public of $41.00 per share. The net proceeds of the public offering are approximately $162.1 milli

Jan 23, 2019 10:16 pm ET

UroGen Pharma Announces Pricing of Public Offering of Ordinary Shares

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the pricing of its public offering of 3,658,537 ordinary shares at a public offering price of $41.00 per share, for a total public offering size of approximately $150.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to

Jan 22, 2019 04:01 pm ET

UroGen Pharma Announces Proposed Public Offering of Ordinary Shares

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that it intends to offer and sell $150 million of its ordinary shares in an underwritten public offering. The company also intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of ordinary shares sold in the offering at the public offering price, less the underwriting discounts and commissions. The offer

Jan 08, 2019 08:00 am ET

UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced topline results from the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). This analysis showed that on an intent-to-treat basis, 57 percent of patients achieved a complete response (CR) rate at their primary disease evalua

Jan 03, 2019 06:30 am ET

UroGen Pharma Appoints Elizabeth (Liz) Barrett as President and Chief Executive Officer

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the appointment of Elizabeth (Liz) Barrett as President and Chief Executive Officer effective immediately. She will also serve on the Company’s Board of Directors. Ms. Barrett, who will be based in New York, replaces Ron Bentsur. Mr. Bentsur will step down from his position at the Company but will continue to serve in an advisory capacity as needed to ensu

Dec 17, 2018 08:00 am ET

UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC)

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) for UGN-101 (mitomycin gel) for instillation as a treatment for patients with low-grade upper tract urothelial cancer (LG UTUC). The company expects to complete its NDA submission by mid-2019, with potential approval in 2019.

Dec 03, 2018 07:25 am ET

Market Trends Toward New Normal in Zillow Group, YRC Worldwide, The Home Depot, UROGEN PHARMA, ZIOPHARM Oncology, and Cinedigm — Emerging Consolidated Expectations, Analyst Ratings

In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Zillow Group, Inc. (NASDAQ:Z), YRC Worldwide, Inc. (NASDAQ:YRCW), The Home...

Nov 12, 2018 08:00 am ET

UroGen Pharma Reports Third Quarter 2018 Financial Results and Completed UGN-101 OLYMPUS Trial Enrollment

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced financial results for third quarter ended September 30, 2018 and that it has completed enrollment of the UGN-101 OLYMPUS Phase 3 Trial in patients with low-grade upper tract urothelial cancer (LG UTUC) following a recent pre-New Drug Application (NDA) meeting held with the U.S. Food and Drug Administration (FDA).

Nov 06, 2018 08:00 am ET

UroGen Pharma to Present at November 2018 Investor Conferences

UroGen Pharma Ltd. (Nasdaq:URGN), today announced that management will present at two investor conferences in November 2018:

Nov 05, 2018 08:00 am ET

UroGen Pharma to Report Third Quarter 2018 Financial Results on Monday, November 12, 2018

UroGen Pharma Ltd. (NASDAQ:URGN) today announced that it will report third quarter 2018 financial results on Monday, November 12, 2018, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at 8:30AM Eastern Time.

Oct 30, 2018 08:00 am ET

FDA Grants Breakthrough Therapy Designation (BTD) for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for instillation. UGN-101 is currently in Phase 3 development for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Breakthrough Therapy Designation is

Oct 24, 2018 08:50 am ET

Market Trends Toward New Normal in UROGEN PHARMA, Cimarex Energy, Boingo Wireless, TransCanada, EXTRACTION O&G, and ACADIA Pharmaceuticals — Emerging Consolidated Expectations, Analyst Ratings

In new independent research reports released early this morning, Market Source Research released its latest key findings for all current investors, traders, and shareholders of UROGEN PHARMA (NASDAQ:URGN), Cimarex Energy Co (NYSE:XEC), Boingo...

Sep 25, 2018 08:00 am ET

UroGen Pharma to Present at the Ladenburg Thalmann 2018 Healthcare Conference

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that Ron Bentsur, Chief Executive Officer, will present at the Ladenburg Thalmann 2018 Healthcare Conference in New York, NY on Tuesday, October 2, 2018 at 2:30PM Eastern Time.

Sep 11, 2018 08:00 am ET

Jones “Woody” Bryan Joins UroGen Pharma as Senior Vice President of Business Development

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company, today announced that Jones “Woody” Bryan, Ph.D. has been appointed as Senior Vice President of Business Development. Dr. Bryan is a seasoned industry veteran who brings to UroGen over 25 years of experience driving growth across organizations with his diverse track record of product and technology licensings and M&A negotiations and transactions. Dr. Bryan will focus on the integration of corporate strategy and business development to assess potential partnerships and

Aug 14, 2018 07:00 am ET

UroGen Pharma Reports Second Quarter 2018 Financial Results and Recent Corporate Developments

Aug 08, 2018 08:00 am ET

UroGen Pharma Appoints Peter P. Pfreundschuh as Chief Financial Officer

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company today announced that Peter P. Pfreundschuh has been appointed as Chief Financial Officer (CFO) effective August 20, 2018. Mr. Pfreundschuh brings to UroGen more than two...

Aug 07, 2018 08:00 am ET

UroGen Pharma to Report Second Quarter 2018 Financial Results on Tuesday, August 14, 2018

UroGen Pharma Ltd. (NASDAQ:URGN) today announced that it will report second quarter 2018 financial results on Tuesday, August 14, 2018, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call...

Jul 11, 2018 08:00 am ET

UroGen Pharma Submits Investigational New Drug (IND) Application for UGN-102 (VesiGel™) for the Treatment of Low-Grade Non-Muscle Invasive Bladder Cancer (LG NMIBC)

Jul 10, 2018 08:00 am ET

UroGen Pharma Appoints Shawn Cline Tomasello to its Board of Directors

Jun 13, 2018 08:00 am ET

UroGen Pharma’s Chairman, Arie Belldegrun, MD, FACS to Receive EY 2018 Master Entrepreneur Award

Jun 06, 2018 07:30 am ET

Investor Expectations to Drive Momentum within Mesoblast, Access National, Urogen Pharma, TechTarget, Sina, and CoStar Group — Discovering Underlying Factors of Influence

In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Mesoblast Limited (NASDAQ:MESO), Access National Corporation...

Jun 05, 2018 08:00 am ET

UroGen Pharma Announces Stephen Mullennix as Interim Chief Financial Officer and Jason Patel as Vice President of Finance

UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, today announced that Stephen Mullennix, UroGen’s Chief Operating Officer, will become Interim Chief...

May 29, 2018 08:00 am ET

UroGen Pharma to Present at the Jefferies 2018 Global Healthcare Conference

May 21, 2018 01:40 pm ET

UroGen Pharma Announces Positive Interim Results from Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for Non-Surgical Treatment of Upper Tract Urothelial Cancer (UTUC)

May 15, 2018 08:00 am ET

UroGen Pharma Reports First Quarter 2018 Financial Results and Recent Corporate Developments

May 08, 2018 08:00 am ET

UroGen Pharma to Report First Quarter 2018 Financial Results on Tuesday, May 15, 2018

UroGen Pharma Ltd. (Nasdaq:URGN) today announced that it will report first quarter 2018 financial results on Tuesday, May 15, 2018, prior to the open of the market. The announcement will be followed by a live audio webcast and conference call at...

Apr 24, 2018 08:00 am ET

UroGen Pharma to Ring the Nasdaq Stock Market Opening Bell

RA’ANANA, Israel and NEW YORK, April 24, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that...

Apr 13, 2018 07:55 am ET

Factors of Influence in 2018, Key Indicators and Opportunity within Dorman Products, Arch Capital Group, Acacia Communications, UROGEN PHARMA, CyrusOne, and TCP Capital — New Research Emphasizes Econo

NEW YORK, April 13, 2018 (GLOBE NEWSWIRE) -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Dorman Products, Inc. (NASDAQ:DORM), Arch Capital...

Apr 03, 2018 08:32 am ET

UroGen Pharma Announces Presentation of Results from Interim Analysis of Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for Non-Surgical Treatment of Upper Tract Urothelial Cancer (UTUC)

RA’ANANA, Israel and NEW YORK, April 03, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced a...

Mar 15, 2018 08:20 am ET

Research Report Identifies Prothena, UROGEN PHARMA, Mizuho Financial Group, 1-800 FLOWERS.COM, Willis Towers Watson Public, and First Connecticut with Renewed Outlook — Fundamental Analysis, Calculati

NEW YORK, March 15, 2018 (GLOBE NEWSWIRE) -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Prothena Corporation PLC (NASDAQ:PRTA), UROGEN PHARMA...

Mar 15, 2018 07:00 am ET

UroGen Reports Fourth Quarter and Full Year 2017 Financial Results

Presentation of MitoGel™ Interim Analysis from OLYMPUS Pivotal Trial in Patients with Low Grade Upper Tract Urothelial Cancer Planned at Upcoming Medical Meeting

Mar 08, 2018 08:00 am ET

UroGen Pharma to Report Fourth Quarter and Full Year 2017 Financial Results on Thursday, March 15, 2018

Conference Call and Webcast Scheduled for 8:30 AM ET

Mar 07, 2018 08:00 am ET

UroGen to Present at March 2018 Investor Conferences

RA’ANANA, Israel and NEW YORK, March 07, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (NASDAQ:URGN) today announced that management plans to present at two investor conferences in March 2018:

Feb 14, 2018 08:00 am ET

UroGen Pharma Strengthens Management Team with the Appointment of Stephen Mullennix as Chief Operating Officer

RA’ANANA, Israel and NEW YORK, Feb. 14, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the...

Jan 23, 2018 04:01 pm ET

UroGen Pharma Announces Closing of Upsized Public Offering of Ordinary Shares and Full Exercise of Underwriters' Option

RA’ANANA, Israel and NEW YORK, Jan. 23, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the...

Jan 18, 2018 07:10 pm ET

UroGen Pharma Announces Pricing of Public Offering of Ordinary Shares

RA'ANANA, Israel and NEW YORK, Jan. 18, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the...

Jan 16, 2018 04:05 pm ET

UroGen Pharma Announces Proposed Public Offering of Ordinary Shares

RA’ANANA, Israel and NEW YORK, Jan. 16, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that...

Jan 08, 2018 08:00 am ET

UroGen Pharma Appoints Former Kite Pharma Executive Christine Cassiano as Corporate Affairs Officer

Kate Bechtold, Also Formerly of Kite Pharma, to Join the Expanded Communications Team as Director of Corporate Communications & Investor Relations

Jan 02, 2018 08:00 am ET

UroGen Pharma to Present at the 36th Annual J.P. Morgan Healthcare Conference

RA’ANANA, Israel and NEW YORK, Jan. 02, 2018 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (NASDAQ:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that...

Dec 12, 2017 08:30 am ET

UroGen Pharma Expands Clinical Development Leadership Team

Mark Schoenberg, M.D., Named Chief Medical Officer

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Urogen Pharma Ltd (OQ:URGN)

Business Focus: Bio Therapeutic Drugs