UroGen Pharma Ltd. (URGN) Faces Securities Class Action Amid FDA's Briefing Document and Subsequent ODAC Vote Against UGN-102- Hagens Berman

SAN FRANCISCO, June 5, 2025 /PRNewswire/ -- A securities class action lawsuit styled Cockrell v. UroGen Pharma Ltd. et al., No. 3:25-cv-06088 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired UroGen securities between July 27, 2023 and May 15, 2025.

The lawsuit comes after investors saw the price of their shares in UroGen Pharma Ltd. (NASDAQ: URGN) crash on May 16, 2025 as a result of the FDA's publication of a briefing document a few days before an upcoming Oncologic Drugs Advisory Committee ("ODAC") meeting, at which ODAC would consider UroGen's new drug application ("NDA") for UGN-102 (a therapy intended to treat patients with low-grade, intermediate-risk non-muscle invasive bladder cancer ("LG-IR-NMIBC")).

Hagens Berman urges UroGen investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys.

Class Period: July 27, 2023 – May 15, 2025
Lead Plaintiff Deadline: July 28, 2025
Visit: www.hbsslaw.com/investor-fraud/urgn
Contact the Firm Now: [email protected]
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The UroGen Pharma Ltd. (URGN) Securities Class Action:

The litigation focuses on the propriety of UroGen's disclosures about its communications with the FDA related to the UGN-102 NDA. UroGen recently assured investors that it designed a pivotal trial ("ENVISON") to support the NDA and that it had an agreement with the FDA that ENVISION could support UGN-102's approval despite the fact that ENVISION was a single-arm trial rather than a randomized trial with a control arm.

More specifically, the complaint alleges that UroGen made materially false and misleading statements while failing to disclose to investors that: (1) the ENVISION clinical study was not designed to demonstrate substantial evidence of UGN-102's effectiveness because it lacked a concurrent control arm; (2) as a result, UroGen would have difficulty demonstrating that the duration of response endpoint was attributable to UGN-102; (3) UroGen failed to heed the FDA's warnings about the study design it used to support its NDA; and (4) as a result of the foregoing there was substantial risk that the NDA would not be approved.

Investors learned the truth on May 16, 2025, when the FDA published its ODAC briefing document. 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. The document further stated that, while the FDA later indicated a single-arm trial could suffice, it must involve a large patient cohort, sufficient follow-up, and strong efficacy and safety. In addition, ODAC was advised "[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."

Ultimately, on May 21, 2025, 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.'"

Each of these events drove the price of UroGen shares sharply lower.

"We're investigating claims that 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," said Reed Kathrein, the Hagens Berman partner leading the investigation.

If you invested in UroGen and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now »

If you'd like more information and answers to frequently asked questions about the UroGen case and our investigation, read more »

Whistleblowers: Persons with non-public information regarding UroGen should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new 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, call Reed Kathrein at 844-916-0895 or email [email protected].

About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.

SOURCE Hagens Berman Sobol Shapiro LLP