UROGEN ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against UroGen Pharma Ltd. and Encourages Investors to Contact the Firm

NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ:URGN) in the United States District Court for the District of New Jersey on behalf of all persons and entities who purchased or otherwise acquired UroGen securities between July 27, 2023 and May 15, 2025, both dates inclusive (the “Class Period”). Investors have until July 28, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

UroGen engages in the development and commercialization of solutions for specialty cancers. According to the complaint, UroGen's lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer.

The UroGen class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) UroGen's ENVISION clinical study for UGN-102 was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm; (ii) as a result, UroGen would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (iii) UroGen failed to heed the U.S. Food and Drug Administration's ("FDA") warnings about the study design used to support a new drug application ("NDA") for UGN-102; and (iv) as a result, there was a substantial risk that the NDA for UGN-102 would not be approved.

The UroGen class action lawsuit further alleges that on May 16, 2025, the FDA published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen's NDA for UGN-102, which stated that "[g]iven that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret," and that the FDA 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, the price of UroGen stock fell nearly 26%, according to the complaint.

Then, on May 21, 2025, the UroGen class action lawsuit further alleges that the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk of the investigation therapy UGN-102 is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock fell nearly 45%, according to the complaint.

If you purchased or otherwise acquired UroGen shares and suffered a loss, are a long-term stockholder, have information, 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 contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Follow us for updates on LinkedIn, X, and Facebook, and keep up with other news by following Brandon Walker, Esq. on LinkedIn and X.

Contact Information:

Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.