#United States #New York #Faruqi & Faruqi #UroGen Pharma #UGN-102

Investor Alert: Investigation Into UroGen Pharma

Faruqi & Faruqi, LLP, a prominent national law firm specializing in securities, has launched an investigation concerning possible legal claims against UroGen Pharma Ltd.. This investigation is aimed at investors who have experienced losses exceeding $75,000 from July 27, 2023, to May 15, 2025, linked to UroGen's performance on the Nasdaq stock exchange. The firm encourages affected shareholders to reach out to discuss their legal options.

Background of the Case

UroGen Pharma, known for its innovative drug UGN-102, faced significant hurdles recently. The U.S. Food and Drug Administration (FDA) released a briefing document addressing the efficacy of UGN-102, stating concerns regarding the design of the ENVISION clinical study. The document noted that the study did not include a concurrent control arm, making it difficult to interpret key outcomes like the complete response rate and the duration of response.

The FDA had repeatedly advised UroGen to consider a randomized trial design during the drug's development, but the company opted not to follow this guidance. This intra-company decision has raised questions about UroGen’s compliance with federal securities laws, specifically regarding misleading statements and potential omissions of critical information from investors.

On May 16, 2025, the disclosure of the FDA's doubts led to a sharp decline in UroGen's stock price, which dropped by 25.8%, closing at $7.31 per share. Subsequent events, including the Oncologic Drugs Advisory Committee’s vote against UGN-102's approval on May 21, caused further catastrophic losses for investors, culminating in a total stock price drop of 44.7%, ending at $4.17 per share.

Legal Consideration for Investors

In the wake of these developments, Faruqi & Faruqi has emphasized the importance of the July 28, 2025 deadline for those wishing to assume the role of lead plaintiff in the ongoing class action lawsuit against UroGen. A lead plaintiff is essentially the representative for the class members who drives the litigation forward. Any investor who suffered losses as outlined may reach out to the firm for assistance.

Anyone with relevant information regarding UroGen’s conduct in this matter is also encouraged to reach out. Whistleblowers, former employees, or shareholders who can provide additional insights are particularly valuable in these investigations.

Conclusion

Faruqi & Faruqi LLP has gained a strong reputation for advocating on behalf of investors, recovering substantial sums in various federal securities litigations since its inception in 1995. Investors affected by the recent UroGen events should consider contacting the firm promptly to discuss their options and rights. For further information about class actions or to discuss your situation with legal experts, please visit www.faruqilaw.com/URGN or reach out to Josh Wilson directly at 877-247-4292 (Ext. 1310).

It's crucial for investors to stay informed and proactive, especially in a rapidly shifting market influenced by regulatory decisions and the evolving landscape of pharmaceuticals. Shareholders are encouraged to monitor their investments and the developments surrounding UroGen closely, as further actions may unfold in the future.