1. A class action lawsuit has been filed against UroGen Pharma. 2. Investors allege securities fraud by UroGen and its officers. 3. FDA briefing raised concerns over UGN-102 trial design. 4. Oncologic Committee rejected UGN-102 NDA due to unfavorable risk profile. 5. UroGen's stock dropped significantly following FDA decisions.
The FDA's rejection and ongoing class action lawsuit significantly undermine investor confidence. Similar issues for biopharmaceuticals have historically led to steep declines in stock values, as seen in past cases like Catalyst Pharmaceuticals.
The article addresses both litigation and regulatory issues that directly affect URGN's market positioning and investor perception, making it highly relevant. Large legal challenges and FDA rejections are top concerns for biotech investors.
The immediate effects of the lawsuit and FDA rejection are likely to impact stock prices swiftly. Historically, stock prices of companies facing lawsuits and regulatory disapprovals drop sharply, often recovering only over an extended period.
NEW YORK, July 2, 2025 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against UroGen Pharma Ltd. ("UroGen" or the "Company") (NASDAQ: URGN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
The class action concerns whether UroGen and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
You have until July 28, 2025, to ask the Court to appoint you as Lead Plaintiff for the class if you purchased or otherwise acquired UroGen securities during the Class Period. A copy of the Complaint can be obtained at www.pomerantzlaw.com.
[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.
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CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980
SOURCE Pomerantz LLP