The filed complaint alleges that UroGen Pharma Ltd. made materially false and/or misleading statements and/or failed to disclose that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of the Company’s lead pipeline product, UGN-102, because it lacked a concurrent control arm; (2) as a result, the Company would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA’s warnings about the study design used to support a drug application for UGN-102; (4) as a result of the foregoing, there was a substantial risk that the NDA for UGN-102 would not be approved; and (5) as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.