UroGen Class Action Lawsuit: 6 Frequently Asked Questions

Table of Contents

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If you suffered losses in UroGen stock, call us today for a free case evaluation about a UroGen Lawsuit. 855-846-6529

Introduction to the UroGen class action lawsuit

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 tmiles@timmileslaw.com.

Lead plaintiff motions for the Red Cat class action lawsuit must be filed with the court no later than July 28, 2028. 

1. If I Sell my Stock, Can I Still be a Part of the UroGen Class Action Lawsuit?

If you sell your stock, you can still be a part of the UroGen class action lawsuit, provided that you meet certain criteria. The eligibility to join the lawsuit typically depends on whether you purchased the stock during the class period specified in the litigation. The class period is a timeframe during which the alleged fraudulent activities or violations occurred, and investors who bought shares within this period may have suffered financial losses due to misinformation or other unlawful practices by the company.

Selling your stock does not disqualify you from participating in the lawsuit; rather, it is your ownership and subsequent financial loss during the relevant period that are critical factors.

It is important to retain records of your transactions, such as purchase and sale dates, to substantiate your claims. These documents will be essential when filing a claim as part of the UroGen class action lawsuit. Additionally, you should stay informed about any updates and deadlines related to the litigation to ensure your rights are protected. Legal counsel can provide guidance on how to proceed and help determine if you are eligible to join the class action based on the specifics of your case.

By participating in the UroGen class action lawsuit, former shareholders like yourself can seek compensation for losses incurred due to alleged wrongdoing by UroGen. This collective legal action aims to hold the company accountable and recover damages for affected investors. Therefore, even after selling your stock, you have a right to pursue justice and potentially receive a portion of any settlement or judgment awarded in the lawsuit.

2. What Are the Allegations in the UroGen 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.

The UroGen class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:

(i) 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;

(ii) as a result, UroGen would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102;

(iii) 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 (iv) 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.

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If you suffered losses in UroGen stock, call us today for a free case evaluation about a UroGen Lawsuit. 855-846-6529

3. What is a Securities Class Action Lawsuit?

A securities class action lawsuit is a legal action taken against a company by a group of shareholders who allege that they have suffered financial losses due to the company’s fraudulent or misleading practices.

These lawsuits are typically filed when shareholders believe that the company has violated securities laws by providing false or incomplete information about its financial health, thereby influencing the stock price. This type of litigation is crucial because it holds companies accountable for their actions and seeks to ensure transparency and honesty in the financial markets. Shareholders, who may have bought or sold securities based on inaccurate information, band together to file these suits, seeking compensation for their losses.

One example of a securities class action lawsuit is the UroGen lawsuit. Shareholders of UroGen could file a lawsuit if they believe that UroGen has misled them about its financial status or the prospects of its products. If, for instance, it was discovered that UroGen had been overstating its earnings or hiding liabilities, and this misinformation caused shareholders to suffer financial losses, those shareholders could come together to file a class action. The UroGen lawsuit would aim to recover damages for all affected investors and to prompt corrective measures within the company to prevent future misconduct.

Such lawsuits are complex and require substantial evidence to prove that the company intentionally misrepresented material information. Successful securities class action lawsuits can result in significant financial settlements for the plaintiffs and can also lead to reforms within the defendant company.

For shareholders, participating in such lawsuits can be a way to recoup losses and advocate for greater corporate responsibility. In the case of the UroGen lawsuit, it could serve as an important mechanism for ensuring that the company adheres to fair and transparent business practices moving forward.

4. What is the Privative Securities Reform Act of 1995?

The Private Securities Reform Act of 1995 (PSLRA) was enacted to curb frivolous securities lawsuits and to enhance investor protection by promoting transparency and accountability among publicly traded companies. This legislation introduced significant changes to securities litigation, including heightened pleading standards for plaintiffs, the requirement to specify misleading statements or omissions, and the imposition of a mandatory stay on discovery while a motion to dismiss is pending.

Additionally, the PSLRA established safe harbor provisions for forward-looking statements to encourage companies to provide future-oriented information without fearing unwarranted legal repercussions.

The PSLRA also aimed to prevent abuses in class action securities lawsuits by instituting measures such as selecting lead plaintiffs with the largest financial interest in the case. This was intended to ensure that those with significant stakes in the outcome would drive the litigation process rather than lawyers seeking quick settlements.

The UroGen class action lawsuit exemplifies how the PSLRA functions in practice. In such cases, affected investors collectively bring forward claims against a company under allegations of securities fraud, relying on the strengthened legal framework provided by the PSLRA to seek redress and hold corporations accountable for actions that may have misled shareholders or caused financial harm.

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If you suffered losses in UroGen stock, call us today for a free case evaluation about about a UroGen Class Action Lawsuit

5. How Is the Greatest Financial Interest Determined in the UroGen Class Action Lawsuit?

The determination of the greatest financial interest in the UroGen lawsuit is a crucial step in class action litigation. This process involves identifying the plaintiff or group of plaintiffs who have sustained the most significant financial losses due to the alleged misconduct by UroGen.

Typically, courts assess various factors to establish financial interest, including the size of the financial loss, the number of shares purchased during the class period, and the timing of these transactions in relation to the purported fraudulent activity.

The plaintiff with the greatest financial interest is often appointed as the lead plaintiff, granting them a central role in steering the direction of the case. This selection is critical as it ensures that those most affected by UroGen’s actions have a prominent voice in seeking justice and potential compensation. Consequently, the efficiency and outcome of the UroGen lawsuit heavily depend on accurately identifying and appointing the lead plaintiff based on their financial interest.

chart showing loss causation in If you suffered losses in UroGen stock, call us today for a free case evaluation about about a UroGen Class Action Lawsuit
If you suffered losses in UroGen stock, call us today for a free case evaluation about about a UroGen Class Action Lawsuit

6. What Does a Lead Plaintiff in a Securities Class Action Do?

A lead plaintiff in a securities class action, such as the UroGen Class Action Lawsuit, plays a critical role in representing the interests of all class members who have been affected by the alleged securities fraud. The lead plaintiff is typically an investor or group of investors who have suffered significant financial losses due to the defendant’s actions.

This party is selected by the court to act on behalf of the entire class, ensuring that their collective claims are effectively pursued. The responsibilities of a lead plaintiff include overseeing the litigation process, assisting in the selection and direction of legal counsel, and making crucial decisions regarding settlement negotiations.

In the context of the UroGen Class Action Lawsuit, the lead plaintiff would work closely with attorneys to build a solid case, gathering evidence, and providing testimony if necessary. Their involvement is essential for achieving a favorable outcome for all investors involved in the class action.

Contact Timothy L. Miles Today About a UroGen Class Action Lawsuit

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Timothy L.Miles

Timothy L. Miles is a nationally recognized shareholder rights attorney raised in Brentwood, Tennessee. Mr. Miles has maintained an AV Preeminent Rating by Martindale-Hubbell® since 2014, an AV Preeminent Attorney – Judicial Edition (2017-present), an AV Preeminent 2025 Lawyers.com (2018-Present). Mr. Miles is also member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a member of its Mass Tort Trial Lawyers Association: Top 25 (2024-present) and Class Action Trial Lawyers Association: Top 25 (2023-present). Mr. Miles is also a Superb Rated Attorney by Avvo, and was the recipient of the Avvo Client’s Choice Award in 2021. Mr. Miles has also been recognized by Martindale-Hubbell® and ALM as an Elite Lawyer of the South (2019-present); Top Rated Litigator (2019-present); and Top-Rated Lawyer (2019-present),

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