UroGen Pharma Ltd. Faces Securities Fraud Investigation Amid FDA Concerns
New York, May 20, 2025 — UroGen Pharma Ltd. (NASDAQ: URGN), a clinical-stage biopharmaceutical company specializing in urological therapies, is currently under investigation by Pomerantz LLP for potential securities fraud. The investigation, announced on May 20, 2025, focuses on whether UroGen and certain of its officers or directors have engaged in unlawful business practices. Investors affected by these developments are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980 for more information.
The investigation follows concerns raised by the U.S. Food and Drug Administration (FDA) regarding UroGen’s clinical trial for its bladder cancer drug, UGN-102 (mitomycin). On May 16, 2025, the FDA released a briefing document ahead of the Oncologic Drugs Advisory Committee meeting scheduled for May 21, 2025. The document highlighted issues with the Envision trial, specifically noting the absence of a concurrent control arm, which complicates the interpretation of the trial’s primary endpoints: complete response and duration of response.
Financial Overview
As of May 19, 2025, UroGen Pharma Ltd. had a closing stock price of $7.54, reflecting a significant decline from its 52-week high of $20.7 on June 13, 2024. The company’s 52-week low was recorded at $6.46 on May 15, 2025. With a market capitalization of approximately $454.16 million, UroGen’s financial metrics have been under scrutiny, particularly its price-to-earnings ratio of -3.25, indicating the company is not currently profitable.
Investor Alert
The ongoing investigation and FDA concerns have prompted investor alert notices. On May 19, 2025, multiple sources, including feeds.feedburner.com, reported on the securities fraud investigation, urging investors who have incurred losses to contact legal representatives for potential class action participation.
As UroGen Pharma Ltd. navigates these challenges, the upcoming FDA advisory committee meeting on May 21, 2025, will be critical in determining the future of UGN-102 and the company’s strategic direction. Investors and stakeholders are closely monitoring the situation for further developments.