UroGen Pharma Ltd. (NASDAQ: URGN)

This lawsuit is for anyone who acquired securities in UroGen Pharma Ltd. (NASDAQ: URGN) from July 27, 2023 through May 15, 2025.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by telling investors that the Company’s bladder cancer drug, UGN-102, was effective without clinical data to support the assertion.

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. On this news, the price of the Company’s stock dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in UroGen Pharma Ltd. (NASDAQ: URGN) from July 27, 2023 through May 15, 2025 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.