URGN CLASS ACTION NOTICE: The Law Offices of Frank R. Cruz Files Securities Fraud Lawsuit Against UroGen Pharma Ltd.

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces that it has filed a class action lawsuit in the United States District Court for the District of New Jersey, captioned Cockrell v. UroGen Pharma Ltd., et al., Case No. 3:25-cv-06088, on behalf of persons and entities that purchased or otherwise acquired UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, inclusive (the “Class Period”). Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).

Investors are hereby notified that they have until 60 days from this notice to move the Court to serve as lead plaintiff in this action.

IF YOU SUFFERED A LOSS ON YOUR UROGEN PHARMA LTD. INVESTMENTS, CLICK HERE TO SUBMIT A CLAIM TO POTENTIALLY RECOVER YOUR LOSSES IN THE ONGOING SECURITIES FRAUD LAWSUIT.

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.

Contact Us To Participate or Learn More:

If you purchased UroGen securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please HERE or contact us at:

Law Offices of Frank R. Cruz
2121 Avenue of the Stars, Suite 800
Telephone: [phone]
Email: [e-mail]
Visit our website at: www.frankcruzlaw.com

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