#United States #New York #Securities Fraud #Pomerantz LLP #UroGen Pharma

Pomerantz Law Firm Class Action Alert

In a significant legal development, the Pomerantz Law Firm has announced the initiation of a class action lawsuit against UroGen Pharma Ltd., a biopharmaceutical company listed on NASDAQ under the symbol URGN. This lawsuit comes as a consequence of substantial losses experienced by investors following a series of troubling announcements regarding UroGen's product approvals, notably affecting its bladder cancer drug, UGN-102.

Background of UroGen Pharma's Legal Challenges

The issues surrounding UroGen came to a head on May 16, 2025, when the U.S. Food and Drug Administration (FDA) released a briefing document leading up to an advisory committee meeting scheduled for May 21. The document raised concerns about the New Drug Application (NDA) for UGN-102, indicating that the Envision clinical trial, which examined the drug’s efficacy, lacked a concurrent control arm. This lack of critical comparative data rendered the trial's primary outcome metrics difficult to interpret.

Furthermore, the FDA had reportedly recommended to UroGen on multiple occasions to utilize a randomized trial design to alleviate concerns about the integrity of the study's results. These warnings went unheeded.

As a direct result of the FDA's unfavorable assessment and the committee’s recommendations, UroGen’s stock plummeted by $2.54 per share— a staggering 25.79% drop— on the day the briefing document was made public. The following week, after the Oncologic Drugs Advisory Committee voted against the approval of UGN-102, citing an unfavorable benefit-risk ratio for patients with non-muscle invasive bladder cancer, UroGen's shares fell further to close at $4.17, a 44.7% drop.

The Class Action Lawsuit

For investors affected by these developments, the Pomerantz Law Firm is actively seeking individuals who purchased or otherwise acquired UroGen securities during the specified class period. Potential plaintiffs are encouraged to reach out before the deadline on July 28, 2025, in order to have their claims considered and potentially assume the role of Lead Plaintiff. To facilitate this process, investors can contact Danielle Peyton at the firm via email at [email protected] or by phone at 646-581-9980.

The lawsuit alleges that UroGen and certain officers and/or directors engaged in securities fraud, thereby misleading investors and causing significant financial losses. Investors who wish to review the formal complaint can access it online at www.pomerantzlaw.com.

Conclusion

This situation serves as a critical reminder of the inherent risks associated with investing in pharmaceutical companies that are subject to regulatory oversight and the unpredictable nature of drug approvals. As UroGen navigates these legal challenges, affected investors have an opportunity to hold the company accountable through collective legal action. It is advisable for investors to document their transactions and seek legal counsel to ensure their rights are protected amidst these developments.

Pomerantz LLP has a long-standing reputation in the realm of corporate and securities law, having recovered significant damages for investors in similar cases. This lawsuit could potentially pave the way for accountability and reparation for those who invested in UroGen at a time when the company's conduct is now under scrutiny.