Glancy Prongay & Murray LLP has announced the filing of a class action lawsuit in the United States District Court for the District of New Jersey, titled Cockrell v. UroGen Pharma Ltd., et al., Case No. 3:25-cv-06088. The lawsuit is on behalf of individuals and entities that purchased or otherwise acquired UroGen Pharma Ltd. (“UroGen” or the “Company”) securities between July 27, 2023, and May 15, 2025, as part of the “Class Period.” The plaintiff is claiming under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
Investors are advised that they have 60 days from the date of this notice to move the court to serve as lead plaintiff in the action.
What Happened?
On May 16, 2025, the U.S. Food and Drug Administration (“FDA”) released a briefing document before its Oncologic Drugs Advisory Committee meeting regarding UroGen’s new drug application (“NDA”) for UGN-102. The FDA expressed doubts about the sufficiency of the submitted data to conclude UGN-102’s effectiveness. The document highlighted that the ENVISION trial lacked a concurrent control arm, making the primary endpoints of complete response (CR) and duration of response (DOR) difficult to interpret. It further stated that the FDA had recommended a randomized trial design to the applicant several times during the product’s development due to these concerns, which UroGen chose not to follow.
This news resulted in a significant drop in UroGen’s stock price, falling $2.54, or 25.8%, to close at $7.31 per share on May 16, 2025, during heavy trading volume.
Subsequently, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against the approval of the UGN-102 NDA. The committee determined that the overall benefit-risk of the investigational therapy is not favorable for patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer.
Following this announcement, UroGen’s stock price declined further by $3.37, or 44.7%, closing at $4.17 per share on May 21, 2025, also amid heavy trading volume.
What Is The Lawsuit About?
The complaint filed in this class action alleges that throughout the Class Period, the defendants made materially false and/or misleading statements and failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, it is alleged that the defendants failed to disclose that: (1) the ENVISION clinical study was inadequately designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control; (2) this would make it challenging for the Company to demonstrate that the duration of response endpoint was attributable to UGN-102; (3) UroGen ignored the FDA’s recommendations regarding the study design for the drug application; (4) as a result, there was a significant risk that the NDA for UGN-102 would not be approved; and (5) consequently, the defendants’ positive representations about the Company’s business, operations, and prospects were materially misleading or lacked a reasonable basis.
If you purchased or otherwise acquired UroGen securities during the Class Period, you may move the Court no later than 60 days from the date of this notice to request the Court to appoint you as lead plaintiff.