A securities class action has been filed against UroGen Pharma Ltd. (URGN) on behalf of persons and entities that purchased or otherwise acquired UroGen securities between July 27, 2023 through May 15, 2025. This case has been filed in the USDC – NJ.
On May 16, 2025, the U.S. Food and Drug Administration published materials in advance of its Advisory Committee meeting regarding UroGen’s drug application for its experimental bladder cancer therapy, UGN-102. The FDA questioned the efficacy and utility of UGN-102. Specifically, the FDA stated that it “does not agree with the statement that the complete response rate for UGN-102 was higher or more durable than that for Transurethral resection of bladder tumor (TURBT)” and that the Company’s claims that UGN-102 may “reduce the burden of repeated TURBTs” lacks long-term data and is unclear. Following this news, UroGen stock price dropped.
The complaint alleges that Defendants made materially false and misleading statements and omissions regarding the effectiveness of a drug, its clinical trial design, and regulatory approval prospects. Plaintiff claims Defendants failed to disclose that the pivotal clinical study lacked a concurrent control arm, making it difficult to establish the drug’s effectiveness, and ignored FDA warnings about the study design. Plaintiff alleges these omissions created a substantial risk that the drug’s approval application would not succeed, rendering Defendants’ positive statements about the company’s operations and prospects misleading and unfounded.