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INVESTOR ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of UroGen

1. Faruqi & Faruqi is investigating claims against UroGen Pharma. 2. Investors may seek legal recourse for losses over $75,000. 3. UroGen faces fallout from FDA doubts on UGN-102's efficacy. 4. NDA for UGN-102 rejected, impacting UroGen's stock significantly. 5. Lead plaintiff role deadline is July 28, 2025.

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FAQ

Why Very Bearish?

Recent FDA decisions and claims of misleading statements severely undermine investor confidence, leading to significant stock price declines, as evidenced by previous drops of 25.8% and 44.7%. Historical precedents show that failed drug approvals often result in steep losses for companies—this could trigger further sell-offs.

How important is it?

The investigations and lawsuits against UroGen present critical risks that could deter investment and provoke significant stock fluctuations. Given UroGen's recent declines, any news of ongoing legal scrutiny directly affects its market perception and overall valuation.

Why Short Term?

Immediate negative sentiment due to FDA rejection and legal investigations may keep stock depressed in the near term. Previous examples, where similar conditions led to swift re-evaluations of stock positions, emphasize this short-term risk.

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UGN-102
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In UroGen To Contact Him Directly To Discuss Their OptionsIf you suffered losses exceeding $75,000 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], /PRNewswire/ -- 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 Logo (PRNewsfoto/Faruqi & Faruqi, LLP) 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.SOURCE Faruqi & Faruqi, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

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