Urogen Class Action Lawsuit: Authoritative, Instructive Extremely Trustworthy Answers to 6 Frequently Asked Questions [2025]

The UroGen class action lawsuit seeks to represent purchasers or acquirers of UroGen Pharma Ltd. (NASDAQ: URGN) securities between July 27, 2023 and May 15, 2025, inclusive (the “Class Period”).  Captioned Cockrell v. UroGen Pharma Ltd., 25-cv-06088 (D.N.J.), the UroGen class action lawsuit charges UroGen and certain of UroGen’s top current and former executives with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff or just have general questions about you rights as a shareholder, please contact attorney Timothy L. Miles of the Law Offices of Timothy L. Miles, at no cost, by calling 855/846-6529 or via e-mail at [email protected]. Lead plaintiff motions for the UroGen class action lawsuit must be filed with the court no later than July 28, 2025.

Read on for answers to the six most frequently asked questions from investors about the UroGen lawsuit.

1. What Are the Allegations in the Urogen Class Action Lawsuit?

UroGen engages in the development and commercialization of solutions for specialty cancers.  According to the complaint, UroGen’s lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer.

1. The UroGen class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
2. UroGen’s ENVISION clinical study for UGN-102 was not designed to demonstrate substantial evidence of effectiveness of UGN-102 because it lacked a concurrent control arm;
3. As a result, UroGen would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102;
4. UroGen failed to heed the U.S. Food and Drug Administration’s (“FDA”) warnings about the study design used to support a new drug application (“NDA”) for UGN-102; and
5. As a result, there was a substantial risk that the NDA for UGN-102 would not be approved.

The UroGen class action lawsuit further alleges that on May 16, 2025, the FDA published a briefing document in advance of its Oncologic Drugs Advisory Committee meeting regarding UroGen’s NDA for UGN-102, which stated that “[g]iven that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret,” and that the FDA had “recommended a randomized trial design to the Applicant several times during their product’s development due to concerns with interpreting efficacy results” but UroGen “chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate.”

On this news, the price of UroGen stock fell nearly 26%, according to the UroGen lawsuit.

Then, on May 21, 2025, the UroGen lawsuit further alleges that the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk of the investigation therapy UGN-102 is not favorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer.

On this news, the price of UroGen stock fell nearly 45%, according to the UroGen lawsuit.

2. What Is the Lead Plaintiff Process in the Urogen Class Action Lawsuit?

Under the Private Securities Litigation Reform Act of 1995 (PSLRA):

• Any investor who purchased and suffered losses in Urogen stock may seek appointment as lead plaintiff in the UroGen class action lawsuit.
• A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.
• A lead plaintiff acts on behalf of all other class members in directing the class action lawsuit.
• The lead plaintiff can select a law firm of its choice to litigate the UroGen lawsuit.
• An investor’s ability to share in any potential future recovery of the class action lawsuit is not dependent upon serving as lead plaintiff.

3. When Is the Lead Plaintiff Deadline in the Urogen Lawsuit?

Lead plaintiff motions for the UroGen class action lawsuit must be filed with the court no later than July 28, 2025. When a securities class action is filed:

1. The person who files the first complaint is required to publish a notice announcing the filing.
2. Anyone who wants to be the lead plaintiff on behalf of the class in the UroGen lawsuit must thereafter file a motion to be appointed as lead plaintiff(s) no later than 60 days after the notice was published.

4. What Is a Securities Fraud Class Action Lawsuit Such as the Urogen Class Action Lawsuit?

A securities fraud class action lawsuit is a legal mechanism through which investors who have suffered financial losses due to fraudulent activities or misleading statements by a company can collectively seek redress. Such lawsuits generally occur when a company, its executives, or other insiders misrepresent or omit crucial information that impacts the company’s stock price, thereby causing investors to make decisions based on faulty or incomplete data.

These lawsuits are essential in maintaining market integrity, ensuring that companies adhere to transparent and honest communication with their shareholders.

One notable example is the UroGen class action lawsuit. Investors in MicroStrategy Inc. allege that the company and its executives engaged in securities fraud by making false or misleading statements regarding the company’s financial health and business prospects. As a result, when the truth was revealed, the stock price plummeted, leading to significant financial losses for shareholders.

In a class action lawsuit like the UroGen class action lawsuit, individual investors combine their claims into a single suit, which increases their leverage against the corporation and makes it more feasible to pursue justice.

These lawsuits follow a rigorous legal process, requiring certification from the court that the group of plaintiffs (the “class”) shares common legal or factual claims.

If successful, a securities fraud class action lawsuit like the UroGen lawsuit can result in substantial financial settlements or judgments against the defendant company, thereby compensating the affected investors and holding the wrongdoers accountable.

In conclusion, securities fraud class action lawsuits are crucial tools for protecting investors and maintaining trust in the financial markets. They offer a way for individuals who might not have the resources to sue independently to band together and challenge corporate misconduct effectively

5. What Is the Private Securities Litigation Reform Act of 1995 and Its Impact on the Urogen Lawsuit?

The Private Securities Litigation Reform Act of 1995 (PSLRA) is a significant piece of legislation enacted by the United States Congress to curb frivolous or unwarranted lawsuits in the securities industry. This law was passed as a response to the increasing number of class-action lawsuits targeting companies, often driven by a drop in stock prices.

The PSLRA aims to enhance the integrity of securities markets by implementing stricter pleading requirements, increasing the burden of proof for plaintiffs, and providing for a stay of discovery while a motion to dismiss is pending. One of the key features of the PSLRA is its requirement that plaintiffs must specify with particularity the misleading statements or omissions, thus preventing vague allegations that could harm companies without merit.

The UroGen class action lawsuit serves as a pertinent example of the impact of the PSLRA. UroGen, a business that engages in the development and commercialization of solutions for specialty cancers, centers on allegations of misleading investors through the provision of inaccurate or incomplete information regarding the company’s financial status and operations.

The UroGen lawsuitt underscores the importance of the PSLRA’s provisions, as it requires substantial evidence from the plaintiffs to proceed with their claims. Ultimately, ensuring that only those with substantial merit can move forward.

Overall, the PSLRA has played a crucial role in balancing the interests of investors and companies by promoting transparency and accountability while protecting businesses from exploitative litigation. By setting higher standards for securities fraud claims, it has helped create a more stable and predictable legal environment for both corporations and investors alike.

6. What Does Opting-out of the Urogen Class Action Lawsuit Mean?

Opting out of a class action lawsuit involves an individual choosing not to participate as a member of the class. In the context of the UroGen class action lawsuit, this means that a shareholder or other affected party would decide to pursue their own separate legal action rather than be part of the collective lawsuit.

Opting out can be a strategic decision based on various factors such as the desire for greater control over the litigation process, potential for a larger individual settlement, or differing personal circumstances that may not align with the class’s claims.

When an individual opts out of a class action, they retain the right to file their own lawsuit against the defendant, in this case, Vestis. This decision must be made within a specified timeframe and in accordance with the procedures outlined by the court overseeing the class action.

It is essential for individuals considering this option to thoroughly evaluate their legal standing and consult with an attorney who can provide guidance tailored to their specific situation.

The UroGen class action lawsuit, like many class actions, seeks to address grievances shared by a large group of plaintiffs who have been similarly affected by the company’s actions. While participating in a class action can streamline the litigation process and reduce individual legal costs, opting out allows for a more customized approach to seeking justice and compensation.

This decision should be made carefully, weighing the potential benefits and drawbacks in light of one’s unique circumstances and goals. If you have substantial losses, you may want to consider opting-out, but remember if you do, you will not be able to participate in any settlement in the UroGen lawsuit.