#United States #San Diego #Class Action #U.S. FDA #UroGen Pharma

UroGen Pharma Investors Seize Opportunity for Class Action Lawsuit

In a significant development for investors in UroGen Pharma Ltd. (NASDAQ: URGN), attorneys at Robbins Geller Rudman & Dowd LLP have announced the opportunity for those who experienced considerable losses to participate as lead plaintiffs in a class action lawsuit. This lawsuit is rooted in claims against UroGen and its executives regarding violations of the Securities Exchange Act of 1934.

Background of the Case

The lawsuit pertains to those who purchased securities between July 27, 2023, and May 15, 2025. The allegations focus on UroGen’s lead product, UGN-102, which was touted as an innovative treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer. However, the FDA had previously raised concerns about the robustness of clinical study designs which lacked a properly randomized control group. This absence has rendered the effectiveness claims of UGN-102 questionable.

Allegations Highlighted

The main points of contention in the case reveal that throughout the designated class period, UroGen's leadership made several misleading statements regarding the efficacy and design of their clinical trials. Specifically, the lawsuit claims:

• - The ENVISION study was poorly designed, failing to demonstrate substantial evidence of the drug’s effectiveness due to a lack of a concurrent control arm.
• - Subsequent interpretations of key outcome measures, such as the duration of response, were complicated and lacked clear attribution to UGN-102.
• - Despite multiple warnings from the U.S. Food and Drug Administration about the inadequacies of their trial design, the company opted not to amend their approach, which raised significant doubts about the potential for FDA approval of their New Drug Application (NDA).

Impact of FDA Findings

The situation escalated dramatically when, on May 16, 2025, the FDA published a briefing document preceding a critical advisory committee meeting, stating that the results from the ENVISION trial were difficult to interpret without a concurrent control group. Following these revelations, UroGen's stock plummeted nearly 26% in a single day.
On May 21, further negative news arrived as the advisory committee voted against recommending approval for UGN-102, leading to another staggering drop of approximately 45% in the stock price.

Seeking Lead Plaintiffs

The Private Securities Litigation Reform Act of 1995 permits any investors who acquired UroGen securities during the specified class period to contest for the role of lead plaintiff in this class action. The lead plaintiff is typically the individual or entity with the largest financial stake in the outcome of the lawsuit and must also be representative of the interests of other affected investors. They may select their preferred legal counsel to represent their case against UroGen, although participation as a lead plaintiff is not a prerequisite for claiming damages in a successful settlement.

About Robbins Geller Rudman & Dowd LLP

Robbins Geller is a leading law firm that specializes in representing investors involved in securities fraud and shareholder litigation. The firm has a robust track record of securing substantial monetary relief for investors, having recovered over $2.5 billion in 2024 alone for various securities-related class action cases. Their acclaim in the industry positions them as a formidable advocate for affected UroGen investors seeking justice.

For those interested in leading the charge against UroGen Pharma and seeking restitution for their losses, more information can be found through Robbins Geller’s dedicated webpage or by contacting their office directly.

Investors are urged to act swiftly, as the window to join as lead plaintiff in this significant class action lawsuit closes on July 28, 2025.