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0.0874089490114466 0.0874089490114466 0.0591935483870969 0.0641259105098856 0.0521592091571281 0.0621748178980231 0.0509885535900104 0.0651899063475547
Stock impact report

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 (URGN)  More Company Research Source: Business Wire
Last urogen pharma ltd earnings: 8/9 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: investors.urogen.com
PDF UGN-101 Joins Select Group of Urologic Oncology Product Candidates to Receive BTD On Track to Initiate Rolling Submission of UGN-101 New Drug Application (NDA) in Q4 2018 RA’ANANA, Israel & NEW YORK--(BUSINESS WIRE)-- 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 designed to expedite the development and review of new drugs to treat serious or life-threatening conditions, so patients may have access to t [Read more]
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