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URGN.US
id: 1613
UroGen Pharma ($URGN) Overstated Drug Data, FDA Non-Approval, and Shareholder Fallout Case
Investors can submit applications for the lead plaintiff role.
D. New Jersey
Court3:25-cv-06088
Case number07/27/2023
Class period Start05/15/2025
Class period End07/28/2025
Lead Plaintiff motion deadline- $URGN investors filed a claim against UroGen Pharma for misleading investors about its bladder cancer drug’s approval prospects by overstating clinical results and ignoring FDA warnings.
- After the FDA questioned the credibility of UroGen’s trial data and later rejected the drug application, $URGN fell a total of 60.5% across two major drops in May 2025.
Case Details:
Between July 27, 2023 and May 15, 2025, UroGen promoted UGN-102 as a breakthrough treatment for non-muscle invasive bladder cancer, claiming it achieved strong results in its ENVISION Phase 3 trial. The company told investors the trial had FDA support and would serve as the basis for drug approval. UroGen said its single-arm trial design, which lacked a control group, was accepted by the agency and sufficient to demonstrate effectiveness.
In reality, the FDA had repeatedly warned UroGen that a randomized trial was necessary to assess efficacy. The agency later made public that the trial’s design made it difficult to tell whether the drug worked or if results were simply due to the disease’s natural history. The FDA also criticized UroGen for ignoring its feedback and failing to run a proper comparator trial.
On May 16, 2025, the FDA released its briefing report stating that UGN-102’s data was unreliable and insufficient. The stock fell 25.8%, closing at $7.31. Then on May 21, 2025, the FDA advisory panel voted against approval, citing an unfavorable benefit-risk profile. $URGN dropped another 44.7%.
Based on these events, $URGN investors filed a claim against UroGen Pharma, accusing the company of the following:
- It misled investors about FDA alignment and trial design acceptability.
- It exaggerated the effectiveness and regulatory readiness of UGN-102.
- It failed to disclose the high risk of rejection due to inadequate trial data.
Considering all the representations, investors believe UroGen concealed regulatory risks and overstated its clinical progress to boost its valuation and investor confidence.
Case Type
US Securities Class Action
Case Status
Lead Plaintiff Submission
Alleged Offence
Misleading Statements,
Financial Misrepresentation,
Fraud,
Failure to Disclose,
Omissions
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
05/16/2025
Filing date
05/29/2025
Lead Plaintiff Deadline
07/28/2025