UroGen Pharma announces FDA clearance for UGN-501 IND application

UroGen Pharma announced that the FDA cleared the company's investigational new drug application, or IND, for UGN-501, an investigational oncolytic virus. The IND clearance enables initiation of a planned Phase 1 clinical study in patients with non-muscle invasive bladder cancer. The Phase 1 study is expected to begin in Q4 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.