The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of investors who purchased UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, inclusive (the “Class Period”). UroGen investors have until July 28, 2025 to file a lead plaintiff motion.

What Happened?

On May 16, 2025, before the market opened, the U.S. Food and Drug Administration (“FDA”) published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen’s new drug application (“NDA”) for UGN-102, which stated the agency doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. In the briefing document, the FDA stated: “[g]iven that [the ENVISION trial] lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret.” The FDA also said it had “recommended a randomized trial design to the Applicant several times during their product’s development due to concerns with interpreting efficacy results” but UroGen “chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.”

On this news, UroGen’s stock price fell $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, on unusually heavy trading volume.

Then, on May 21, 2025, before the market opened, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA. The committee found that the overall benefit-risk of the investigational therapy UGN-102 (intravesical mitomycin) is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer.

On this news, UroGen’s stock price fell $3.37, or 44.7%, to close at $4.17 per share on May 21, 2025, on unusually heavy trading volume.

What Is The Lawsuit About?

The complaint filed in this class action 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, 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.