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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of UroGen Pharma Ltd.  - URGN

1. Pomerantz LLP is investigating potential securities fraud by UroGen Pharma. 2. The FDA criticized UroGen's trial design for bladder cancer drug UGN-102. 3. UroGen's stock dropped 25.79% following adverse FDA feedback. 4. A class action may be formed if fraud claims are substantiated. 5. The FDA recommended a randomized trial design for better clarity.

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FAQ

Why Very Bearish?

The severe FDA feedback and investigation indicate serious operational issues, potentially lowering investor confidence.

How important is it?

The ongoing investigation and FDA concerns directly threaten UroGen's market standing, likely influencing stock performance.

Why Short Term?

Immediate investor reactions are likely to impact stock prices, particularly in light of the investigation and FDA comments.

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FDAPFEBMY
NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether UroGen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On May 16, 2025, the U.S. Food and Drug Administration (“FDA”) posted a briefing document for the Oncologic Drugs Advisory Committee meeting, scheduled for May 21, 2025, to discuss the New Drug Application for UroGen’s bladder cancer drug UGN-102 (mitomycin).  Among other things, the briefing document said that because the Company’s Envision trial lacked a concurrent control arm, the trial’s primary endpoints of complete response and duration of response are difficult to interpret.  The FDA further stated that it recommended a randomized trial design “several times” to UroGen to assuage these concerns.  On this news, UroGen’s stock price fell $2.54 per share, or 25.79%, to close at $7.31 per share on May 16, 2025. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT:Danielle PeytonPomerantz LLPdpeyton@pomlaw.com646-581-9980 ext. 7980

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