Urogen Class Action Lawsuit: Meticulous and Comprehensive Answers to 6 Extremely Important 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 of the UroGen class action lawsuit, 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 six of the most frequently asked questions from investors in the UroGen class action lawsuit.

1. What Is Opting Out of a Securities Class Action?

Opting out of a securities class action refers to the formal decision by an individual investor or entity to exclude oneself from participating in a collective lawsuit against a corporation for alleged securities fraud or violations. In the context of a Urogen Class Action Lawsuit, opting out means that an investor decides not to be part of the group litigation initiated against Urogen Pharma Ltd. or its executives.

This decision is typically made during a specified period, often detailed in the notice of class action that is sent to potential class members. Opting out allows the individual to pursue their own legal remedies independently rather than being bound by the outcome of the class action.

There are several reasons why an investor might choose to opt out of a Urogen Class Action Lawsuit. One significant reason is the desire for greater control over the litigation process and potential settlement negotiations. By opting out, an investor can hire their own attorney, tailor their legal strategy, and possibly achieve a more favorable or expedient resolution than what might be obtained through a class action.

Additionally, investors with substantial claims might feel that they stand to gain more by pursuing an individual lawsuit than by sharing any settlement or judgment with potentially thousands of other class members.

However, opting out of a securities class action also comes with risks and considerations. It can be costly and time-consuming to pursue individual litigation, as it involves hiring legal representation, gathering evidence, and potentially enduring a lengthy court process. Moreover, there is no guarantee of success; an individual lawsuit could result in no recovery at all if the court rules in favor of the defendant.

Furthermore, those who opt out relinquish the benefits of collective bargaining power inherent in a class action, where the combined claims of many can exert significant pressure on defendants to settle.

Investors contemplating whether to opt out of a Urogen Class Action Lawsuit should carefully evaluate their specific circumstances, including the strength of their claims, the potential costs involved, and their appetite for legal risk. Consulting with a securities litigation attorney can provide valuable insights and guidance tailored to their unique situation. Ultimately, opting out is a strategic decision that requires thorough consideration of both potential rewards and drawbacks.

2. What Is the Private Securities Litigation Reform Act of 1995?

The Private Securities Litigation Reform Act of 1995 (PSLRA) was enacted by the United States Congress to curb frivolous securities lawsuits and to promote greater accountability in securities fraud allegations. This landmark legislation was introduced in response to concerns about the increasing number of meritless lawsuits targeting companies and their executives, which often resulted in costly settlements irrespective of the veracity of the claims. The PSLRA aimed to strike a balance between protecting investors from fraudulent activities and shielding businesses from unwarranted legal battles.

One of the key provisions of the PSLRA is the imposition of heightened pleading standards for plaintiffs in securities fraud cases. Unlike previous standards, plaintiffs must now specify each statement alleged to have been misleading, explain why the statement is misleading, and provide a strong inference that the defendant acted with the requisite intent.

This rigorous requirement ensures that only well-founded claims proceed to discovery, thereby deterring opportunistic lawsuits. Additionally, the PSLRA introduced a mandatory stay of discovery pending any motion to dismiss, helping to prevent unnecessary litigation costs for defendants when faced with potentially unfounded allegations.

Another significant aspect of the PSLRA is the creation of a “safe harbor” for forward-looking statements. This provision encourages companies to provide projections and other forward-looking information without the fear of litigation, as long as these statements are accompanied by meaningful cautionary language that identifies risk factors. This safe harbor aims to foster transparency and allow investors to make more informed decisions based on future expectations rather than solely historical performance.

The PSLRA also includes measures to reduce conflicts of interest among plaintiffs’ lawyers and class representatives. It mandates that courts select lead plaintiffs who are most capable of representing the interests of the entire class, typically institutional investors with significant financial stakes. This provision seeks to ensure that class actions are driven by those with genuine investment interests rather than by attorneys seeking lucrative fees.

An example of a case impacted by the PSLRA is the Urogen Lawsuit, where investors alleged that Urogen Pharma Inc. misled them about its financial health and prospects. The heightened pleading standards and discovery stay provisions played a crucial role in determining the course of this lawsuit, emphasizing the importance of robust evidence and clear intent before proceeding with claims.

In conclusion, the Private Securities Litigation Reform Act of 1995 represents a pivotal shift in securities litigation, fostering a more balanced legal environment that protects both investors and businesses. By implementing stricter pleading requirements, offering safe harbor provisions, and reducing conflicts of interest, the PSLRA has significantly influenced how securities fraud cases are pursued and resolved.

3. What Is a Lead Plaintiff in a Securities Class Action?

A lead plaintiff, also known as a class representative, plays a crucial role in a securities class action lawsuit. This individual or entity is selected to represent the interests of the entire class of plaintiffs who have allegedly been harmed by securities fraud or other violations of securities law. The lead plaintiff in a Urogen Class Action Lawsuit, for instance, would represent all investors who suffered financial losses due to any purported misconduct by Urogen Pharma Ltd.

The selection of a lead plaintiff is a critical step in the class action process, as this person or entity is responsible for making key decisions on behalf of the class, including selecting class counsel, guiding litigation strategy, and potentially negotiating settlements.

The appointment of a lead plaintiff is governed by criteria set forth in the Private Securities Litigation Reform Act (PSLRA) of 1995. The PSLRA aims to ensure that the most capable and motivated investor, often with the largest financial stake, serves as the lead plaintiff. This helps align the interests of the lead plaintiff with those of the other class members. In the case of a Urogen Class Action Lawsuit, the court would review applications from various potential lead plaintiffs and select the one best suited to advocate on behalf of all affected investors.

Once appointed, the lead plaintiff must act in a fiduciary capacity, meaning they must prioritize the best interests of the class above their own. This role requires diligent oversight and participation throughout the litigation process. In securities class actions like the Urogen Class Action Lawsuit, an effective lead plaintiff can significantly influence the outcome, working to achieve a fair resolution and maximum recovery for all class members involved.

4. 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 complaint.

Then, on May 21, 2025, the UroGen class action 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 complaint.

5. What Is a False and Misleading Statement Under the PSLRA?

Under the Private Securities Litigation Reform Act (PSLRA), a false and misleading statement is defined as any untrue assertion or omission of a material fact that can affect an investor’s decision to buy or sell securities. The PSLRA was enacted to curb frivolous lawsuits in the securities market by establishing stringent pleading requirements for plaintiffs.

Specifically, a plaintiff must demonstrate with particularity that the defendant made a false statement or omitted a material fact with the intent to deceive, manipulate, or defraud. This high standard of proof aims to protect companies from baseless claims while still providing recourse for investors genuinely harmed by fraudulent activities.

In the context of securities litigation, such as the Urogen lawsuit, plaintiffs must meticulously document that the misleading information was directly responsible for their financial losses. For instance, if Urogen were to release financial statements or public disclosures that inaccurately represented its earnings projections or market potential, and investors relied on these statements when making their investment decisions, those investors might then have grounds for a lawsuit under the PSLRA.

The law requires detailed evidence showing that the company’s actions were not only false but also significantly detrimental to the investors’ interests.

Moreover, the PSLRA mandates that plaintiffs must show a strong inference of scienter, meaning that the defendant acted with wrongful intent or severe recklessness. This requirement is intended to distinguish between genuine fraud and mere negligence or poor business judgment. In cases like the Urogen lawsuit, proving scienter involves presenting credible evidence that company executives knowingly disseminated false information with the purpose of misleading investors.

By setting these rigorous standards, the PSLRA aims to strike a balance between protecting investors from deceit and shielding businesses from opportunistic legal actions.

6. What Is the Automatic Stay of Discovery Under the PSLRA?

The Private Securities Litigation Reform Act (PSLRA) includes a provision known as the automatic stay of discovery, which is critical in securities class action lawsuits. This provision mandates a halt on all discovery processes as soon as a motion to dismiss is filed by the defendant. The automatic stay of discovery aims to prevent plaintiffs from using the discovery process to coerce settlements based on the burdensome cost and effort required for compliance.

Instead, it ensures that the legal sufficiency of the complaint is evaluated before any extensive and potentially intrusive discovery procedures commence. This stay remains in effect until the court has ruled on the motion to dismiss or if special circumstances require lifting the stay. In high-profile cases such as a Urogen Class Action Lawsuit, this provision can play a significant role in determining how quickly and efficiently a case progresses through the courts.

For instance, in a Urogen Class Action Lawsuit where shareholders may allege securities fraud or misleading statements, defendants can file a motion to dismiss the case based on specific legal grounds. During this period, the automatic stay of discovery under PSLRA prevents plaintiffs from demanding documents, depositions, or other discovery-related activities that could impose substantial costs or pressure on defendants.

This mechanism is designed to filter out frivolous claims early in litigation, ensuring that only those with a factual and legal basis proceed. By temporarily halting discovery, courts can focus on the merits of the motion to dismiss without the distraction or burden of ongoing discovery requests. Understanding this aspect of PSLRA is crucial for anyone involved in securities litigation, as it shapes the strategy and timing of legal actions in complex cases like the Urogen Class Action Lawsuit.