Author Archives: Jen

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)

Data Demonstrates Complete Response (CR) Rate of 57 Percent in Patients with LG UTUC All Evaluated Patients in CR Remain Disease Free at Six Months Rolling Submission of New Drug Application (NDA) Initiated in December 2018 NEW YORK–(BUSINESS WIRE)–Jan. 8, 2019– UroGen … Continue reading

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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)

UGN-101 Has the Potential to Become the First Drug Ever Approved for LG UTUC Submission Supported by Pivotal Phase 3 OLYMPUS Study; Topline Results to be Presented in January 2019 Company Expects to Complete NDA Submission by mid-2019, with Potential Approval … Continue reading

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UroGen Pharma to Present at November 2018 Investor Conferences

RA’ANANA, Israel & NEW YORK–(BUSINESS WIRE)–Nov. 6, 2018– UroGen Pharma Ltd. (Nasdaq:URGN), today announced that management will present at two investor conferences in November 2018: Stifel 2018 Healthcare Conference Tuesday, November 13 9:30AM Eastern Time New York, NY Jefferies 2018 London Healthcare Conference Thursday, November 15 9:20AM Greenwich … Continue reading

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

Following a Recent Pre-New Drug Application (NDA) Meeting with the FDA for UGN-101, the Company Has Concluded Patient Enrollment in the OLYMPUS Phase 3 Trial for Low-Grade Upper Tract Urothelial Cancer (LG UTUC) Breakthrough Therapy Designation (BTD) Previously Granted by the FDA for UGN-101 … Continue reading

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