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UroGen Pharma Ltd. Class Action Lawsuit: A Vital Opportunity for Investors

In a significant legal development, Robbins Geller Rudman & Dowd LLP has announced an opportunity for investors who incurred substantial losses in UroGen Pharma Ltd. (NASDAQ: URGN) to participate in a class action lawsuit. This urgent call is directed at individuals who purchased or acquired UroGen securities between July 27, 2023, and May 15, 2025. Importantly, the deadline for seeking appointment as the lead plaintiff in this lawsuit is July 28, 2025.

The class action lawsuit, titled Cockrell v. UroGen Pharma Ltd., is presently filed in the District of New Jersey (Case No. 25-cv-06088). The lawsuit alleges serious violations of the Securities Exchange Act of 1934, charging both UroGen and certain executives with misleading statements and failures to disclose critical information regarding the effectiveness of their leading product, UGN-102.

Allegations Against UroGen Pharma

According to the lawsuit, UroGen Pharma, which is dedicated to developing treatments for specialty cancers, particularly highlighted their product, UGN-102, an intravesical solution tailormade for treating low-grade intermediate-risk non-muscle invasive bladder cancer. However, the complaint asserts that key aspects related to UroGen's ENVISION clinical study for UGN-102 were not adequately conveyed to investors, raising significant concerns regarding product efficacy.

1. Ineffective Study Design: The complaint argues that the design of the ENVISION clinical study did not effectively demonstrate the product's validity as there was a lack of a concurrent control arm. Consequently, this raised daunting uncertainties about whether the duration of response could be solely attributed to UGN-102.

2. FDA Warnings Ignored: Allegations also specify that UroGen failed to heed critical warnings from the U.S. Food and Drug Administration (FDA) about the study's design in context with a new drug application for UGN-102. The ramifications of this misstep might impact the approval process negatively.

3. Stock Price Impacts: Significant drops in the company’s stock price were reportedly linked to the failure to disclose this vital information. Following FDA comments highlighting concerns regarding the study design, UroGen's stock suffered a staggering 26% decline on May 16, 2025. In the aftermath of a rejection from the Oncologic Drugs Advisory Committee on May 21, 2025, the stock plummeted nearly 45% as the overall risk-benefit analysis of UGN-102 was deemed unfavorable.

The Process for Becoming a Lead Plaintiff

The Private Securities Litigation Reform Act of 1995 specifies that any investor who purchased or acquired UroGen securities during the outlined period may apply to become the lead plaintiff of this class action lawsuit. The lead plaintiff typically is the individual with the most significant financial stake in the outcome of the case who also maximally represents the interests of all the class members.

It’s worth noting that potential investors can contact attorneys J.C. Sanchez or Jennifer N. Caringal at Robbins Geller by calling 800-449-4900 or emailing [email protected] for more information on the process.

About Robbins Geller Rudman & Dowd LLP

Robbins Geller is regarded as one of the premier law firms dedicated to representing investors in cases of securities fraud and shareholder litigation. Over the last five years, this firm has repeatedly earned accolades, having secured record monetary relief for investors. In 2024 alone, they successfully recovered over $2.5 billion for clients involved in securities-related class actions.

Investors looking to protect their interests and possibly gain compensation for their losses in UroGen should consider this opportunity to act now. More details can be found on their official litigation page specializing in securities fraud. Don't hesitate to reach out and safeguard your financial rights today!