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Investor Alert: Pomerantz Law Firm's Investigation into UroGen Pharma Ltd.

On May 20, 2025, the Pomerantz Law Firm, renowned for its expertise in corporate and securities class litigation, announced an investigation concerning potential securities fraud and other unlawful practices involving UroGen Pharma Ltd. This investigation follows troubling developments regarding the company’s bladder cancer treatment, UGN-102 (mitomycin).

Background on UroGen Pharma Ltd.

UroGen, traded under the NASDAQ ticker URGN, has been under scrutiny after the FDA released a briefing document on May 16, 2025. This document was prepared for the upcoming Oncologic Drugs Advisory Committee meeting, set for May 21, 2025, which will review the New Drug Application for UroGen's promising bladder cancer drug.

The FDA report highlighted significant concerns regarding UroGen's clinical trial design for the Envision trial. The trial lacked a concurrent control arm, rendering the primary endpoints related to the treatment's effectiveness—namely the complete response and its duration—difficult to interpret. The FDA had previously recommended a randomized trial design multiple times to mitigate these concerns. These revelations have raised alarms about UroGen's adherence to regulatory expectations and, consequently, the integrity of its clinical data.

Impact on Investors and Stock Price

As news of the FDA's findings emerged, UroGen’s stock faced a dramatic downturn. On May 16, the company's shares plummeted by $2.54, marking a staggering 25.79% loss that brought the stock price down to $7.31 per share. This sudden decline reflects investor apprehensions over the viability of UroGen's product and its future market potential, raising questions about whether the company had been fully transparent in its disclosures about the trial's validity and outcomes.

Pomerantz LLP urges anyone who invested in UroGen to reach out, as this investigation could hold significant implications for investors seeking recourse following the stock's decline. Danielle Peyton can be contacted at [email protected] or via phone at 646-581-9980, ext. 7980, for those who wish to discuss their rights in this scenario.

About Pomerantz LLP

Founded by Abraham L. Pomerantz, often referred to as the dean of the class action bar, Pomerantz LLP is one of the leading firms specializing in corporate class action lawsuits. With a legacy spanning over 85 years, the firm has been pivotal in advocating for victims of securities fraud and corporate misconduct, advocating for investor rights with various successful recoveries in class action lawsuits. The firm is headquartered in New York City and has additional offices in Chicago, Los Angeles, London, Paris, and Tel Aviv.

As the situation unfolds, the focus will remain on how UroGen addresses these concerns and what this means for its stakeholders moving forward. Investors are encouraged to stay informed about the forthcoming FDA meeting and any further announcements from UroGen Pharma regarding their drug application and clinical trial results.