UroGen Pharma (URGN) Misses Q3 EPS by 23c
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UroGen Pharma Reports Third Quarter 2018 Financial Results and Completed UGN-101 OLYMPUS Trial Enrollment
November 12, 2018 8:00 AM ESTFollowing 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 for the Treatment of LG UTUC
Company On Track to Initiate UGN-101 Rolling NDA Submission to the FDA in Q4 2018 with Completed Submission in Q2 2019 and Potential Approval in 2019
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