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

1. Pomerantz LLP investigates potential securities fraud by UroGen Pharma. 2. FDA questioned UGN-102 trial's validity, affecting drug approval chances. 3. Stock plummeted 25.79% on FDA findings and 44.7% after NDA rejection. 4. Advisory Committee deemed UGN-102's benefit-risk profile unfavorable. 5. Investors urged to join the class action regarding possible misconduct.

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FAQ

Why Very Bearish?

The significant drop in UroGen's stock (over 68%) following unfavorable FDA findings indicates market loss of confidence, reminiscent of past drug approval rejections in biotech leading to long-term stock devaluation.

How important is it?

The investigation reveals critical legal and operational vulnerabilities, significantly influencing investor sentiment and company valuation.

Why Short Term?

Immediate investors' actions will dictate stock behavior, especially as the investigation evolves, similar to other biotech companies facing legal scrutiny which often results in sustained short-term volatility

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NEW YORK, June 23, 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 (“NDA”) 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.  Then, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against approving the NDA for UGN-102 after finding that the drug’s overall benefit-risk profile was 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 per share, or 44.7%, to close at $4.17 per share on May 21, 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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