According to the Complaint, UroGen Pharma Ltd. engages in the development and commercialization of solutions for specialty cancers. The Company’s lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. Since commencing operations, the Company has devoted substantially all of its efforts to develop UGN-102 and obtain regulatory approval. This lawsuit was filed against UroGen and three of its Officers.

On August 14, 2024, the Company completed the submission of the rolling new drug application for UGN-102. UroGen sought U.S. FDA approval for UGN-102 based on data from several studies, including the pivotal ENVISION trial, the earlier OPTIMA II study, and the partially completed ATLAS randomized trial.

The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants failed to disclose to investors that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of effectiveness of 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.

On June 13, 2025, Plaintiff filed a Notice with the Court voluntarily dismissing this action.