UroGen Pharma receives FDA fast track designation for MitoGel for the treatment of upper tract urothelial carcinoma

UroGen Pharma

29 August 2017 - UroGen Pharma today announced that the U.S. FDA has granted fast track designation for the Company’s lead product candidate, MitoGel, for the treatment of patients with low-grade upper tract urothelial carcinoma not amendable to endoscopic resection or with contra-indication to nephroureterectomy, including impaired renal function. 

MitoGel is currently being evaluated in the ongoing, single-arm, open-label, pivotal Phase 3 OLYMPUS clinical trial in patients with low-grade UTUC.

Read UroGen Pharma press release


Michael Wonder

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Michael Wonder

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Medicine , Fast track