UroGen Pharma Ltd. (URGN) Investigation

The investigation focuses on the propriety of UroGen’s disclosures about its communications with the FDA related to its UGN-102 New Drug Application (“NDA”). UroGen recently assured investors that it designed a pivotal trial (“ENVISON”) and that it had an agreement with the FDA that ENVISION could support approval of UGN-102 even though ENVISION was a single-arm, not a randomized, trial design.

On May 21, UroGen announced that ODAC voted 5 to 4 against the risk/profile of UGN-102 for the treatment of patients with recurrent LG-IR-NMIBC. One ODAC member reportedly said “‘I voted no. Without a full randomized trial […] it is hard to determine the true benefit of [UGN-102].’” The member also reportedly said “‘There is very limited long-term follow-up.’” This news sent the price of UroGen shares down $3.37 (-44%) that day.

This latest development follows the May 16, 2025 publication of the FDA’s briefing document for the ODAC meeting. The document reflected that the FDA repeatedly advised UroGen to conduct a randomized trial for UGN-102 due to concerns about accurately interpreting efficacy and distinguishing the drug's effects from the natural course of the disease, as well as the lack of comparative safety data. While the FDA later indicated a single-arm trial could suffice if it involved a large patient cohort, sufficient follow-up, and strong efficacy and safety, the agency now disputes UroGen's claim that the pivotal Phase 3 ENVISION trial established UGN-102's efficacy. The FDA asserts that ENVISION's single-arm design prevents a robust evaluation of response duration because it lacks a control group and is susceptible to selection bias. This design, according to the FDA briefing document, makes it impossible to determine if the observed response is due to UGN-102 or the disease's natural history, ultimately rendering the drug's proposed utility unclear due to difficulties in assessing recurrence risk.

In response to the briefing document, the price of UroGen shares fell over 25% on May 16, 2025.  

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the URGN investigation about?

We are investigating if UroGen may have misled investors about its communications with the FDA, particularly about the agency’s concerns over- and qualifications to- the company’s use of a single-arm trial design.

WHAT SHOULD I DO?

I worked at URGN. What should I do?

If you were an employee of URGN, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in URGN, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any URGN investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.