UroGen Pharma Ltd. (URGN) Shares Crash Again Amid FDA’s ODAC Vote Against UGN-102, Company Facing Investor Scrutiny – Hagens Berman

/EIN News/ -- SAN FRANCISCO, May 22, 2025 (GLOBE NEWSWIRE) -- On May 21, 2025, investors in UroGen Pharma Ltd. (NASDAQ: URGN) saw the price of their shares crash 44% after the company announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted against the risk/benefit profile of UroGen’s UGN-102, a therapy intended to treat patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (“LG-IR-NMIBC”) for which no drugs are currently FDA-approved.

Hagens Berman has opened an investigation into possible securities law violations and 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.

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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.

“We’re 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,” 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 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 URGN@hbsslaw.com.

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. 

Contact:
Reed Kathrein, 844-916-0895