Faruqi & Faruqi Initiates Investigation on UroGen Pharma Investors Claims

Investigation into UroGen Pharma Ltd. by Faruqi & Faruqi

Faruqi & Faruqi, LLP, a prominent national securities law firm, has launched an investigation into potential claims concerning UroGen Pharma Ltd.. The firm is particularly focused on investors who acquired securities in UroGen between July 27, 2023, and May 15, 2025. Investors who have suffered losses during this period are encouraged to reach out to the firm to discuss their legal rights and potential remedies.

Overview of the Situation

On June 10, 2025, the firm announced that it identified several alarming issues related to UroGen's operations, primarily tied to the ENVISION clinical study. The allegations suggest that UroGen, along with its executives, might have violated federal securities laws. Specifically, they are accused of making misleading statements and failing to disclose critical information regarding the efficacy of UGN-102, a drug for treating bladder cancer. This investigation comes in light of the recent developments concerning the FDA's assessment of UroGen’s drug application.

The ENVISION study's design has been called into question, particularly due to its lack of a concurrent control arm, raising doubts about the validity of the reported results. Consequently, this has led to significant risks regarding UroGen's ability to secure approval for UGN-102, as indicated by the FDA’s own recommendations throughout the drug's development phase. Despite these warnings, UroGen proceeded with its application without adhering to the FDA's advice for an appropriate randomized trial design.

Impact of FDA Statements

On May 16, 2025, the FDA released a briefing document that cast serious doubt on UroGen's claims, stating that the data provided was insufficient to ascertain the effectiveness of UGN-102. This statement triggered a dramatic fall in UroGen's stock price, dropping by 25.8%, closing at $7.31 per share, following significant trading volume. The negative sentiment only escalated when, just a few days later on May 21, the Oncologic Drugs Advisory Committee formally voted against the application for UGN-102, citing an unfavorable overall benefit-risk assessment for patients with specific cancer profiles. Following this news, the stock price plummeted further by 44.7%, ending the trading day at $4.17 per share.

Legal Options for Investors

As a result of these developments, potential class action suits could emerge against UroGen. Any investor interested in exploring their legal options can either seek to be appointed as the lead plaintiff or simply remain a member of the class without taking an active role in the proceedings. Faruqi & Faruqi has also emphasized that individuals possessing pertinent information regarding UroGen’s actions, such as former employees or whistleblowers, should come forward to assist with the investigation.

To engage in further discussions or to learn more about the potential class action against UroGen, individuals can visit the firm’s dedicated web page or contact Josh Wilson, a partner at Faruqi & Faruqi, directly at either 877-247-4292 or 212-983-9330 (Ext. 1310).

Conclusion

The ongoing investigation by Faruqi & Faruqi underscores the significant risks associated with investments in UroGen Pharma Ltd. As the situation continues to unfold, investors are urged to stay informed and consider their options carefully, especially with a looming deadline to appoint a lead plaintiff which is set for July 28, 2025. For those affected, this could represent a crucial chance to seek restitution for their losses in what appears to be a troubling chapter for UroGen.