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URGN Investors with Large Losses Should Contact Robbins LLP for Information About the Class ...

  • On June 6, 2025, Robbins LLP announced the filing of a class action lawsuit representing investors who bought or acquired shares of UroGen Pharma Ltd. Between late July 2023 and mid-May 2025.
  • The action follows UroGen's submission of a rolling NDA for UGN-102 in August 2024 and subsequent FDA doubts about the drug's efficacy data.
  • The FDA briefing on May 16, 2025, highlighted the absence of a simultaneous control group in the ENVISION study, which complicated the interpretation of key efficacy measures, and noted that randomized trials had been repeatedly suggested during the development process.
  • Following the Oncological Drugs Advisory Committee’s May 21, 2025 vote against approval, UroGen’s stock fell 44.7%, reflecting concerns about UGN-102's unfavorable benefit-risk profile.
  • The lawsuit alleges UroGen failed to disclose trial design flaws and risks of NDA rejection, potentially allowing investors to seek recovery without fees by July 28, 2025.
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PR Newswire broke the news in United States on Friday, June 6, 2025.
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