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SHAREHOLDER NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen

1. Faruqi & Faruqi is investigating UroGen for securities violations. 2. UGN-102's clinical study lacked substantial evidence of effectiveness. 3. FDA doubts UGN-102 effectiveness, impacting its NDA approval prospects. 4. UroGen's stock price has already significantly declined post-FDA comments. 5. Class action deadline for investors is July 28, 2025.

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FAQ

Why Very Bearish?

Concerns over UGN-102's approval have directly resulted in large stock price drops.

How important is it?

The legal investigation and FDA doubts could severely impact UroGen's market position.

Why Short Term?

Stock reactions to FDA findings and class action may affect immediate trading.

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Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In UroGen To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in UroGen between July 27, 2023 and May 15, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN) and reminds investors of the July 28, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See www.faruqilaw.com. As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose 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. 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. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.   Faruqi & Faruqi, LLP also encourages anyone with information regarding UroGen’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the UroGen Pharma Ltd. class action, go to www.faruqilaw.com/URGN or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Follow us for updates on LinkedIn, on X, or on Facebook. Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4c96193e-9e8a-4e5d-878a-3e41b441e24a

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