A securities class action has been filed in the USDC — N.J. against Urogen Pharma Ltd. (URGN) (“Urogen” or the “Company”) on behalf of all persons and entities that purchased or otherwise acquired Urogen securities between July 27, 2023, and May 15, 2025, both dates inclusive (the “Class Period”).

UroGen 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.

The complaint alleges 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, Defendants made 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 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, thereby harming investors.

UroGen’s stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025.

If you purchased Urogen securities during the class period and would like to receive more information or join the action, please enter your contact information below for a FREE consultation and click “Submit Your Information”.

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