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Did UroGen Pharma Ltd. (URGN) Mislead Investors?

1. Levi & Korsinsky begins investigation into UroGen Pharma for possible securities violations. 2. FDA's comments on ENVISION limit interpretation of UGN-102 data. 3. UroGen's stock price dropped following FDA's statements on trial results.

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Why Bearish?

The FDA's concerns coupled with an investigation represent significant risks for URGN. Stock prices in biotech often react negatively to potential legal issues or regulatory doubts.

How important is it?

The article highlights significant legal risk concerning URGN, which could deter investors. Legal actions over security violations can substantially reshape market perceptions.

Why Short Term?

Investigative news generally impacts stock prices quickly as concerns arise. Historical examples show that sector-specific investigations lead to immediate negative price responses.

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VNDAALNYINFI
NEW YORK, NY / ACCESS Newswire / May 28, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of UroGen Pharma Ltd. ("UroGen Pharma Ltd.") (NASDAQ:URGN) concerning possible violations of federal securities laws.On May 16, 2025, the FDA stated: "Given that ENVISION lacked a concurrent control arm, the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret. While CR indicates drug activity of UGN-102, it is unclear whether the observed DOR can be attributed to the investigational product or instead reflects the natural history of the disease." Following this news, the price of the Company's stock dropped on the same day. To obtain additional information, go to:https://zlk.com/pslra-1/urogen-pharma-ltd-lawsuit-submission-form?prid=150543&wire=1&utm_campaign=47or contact Joseph E. Levi, Esq. either via email at [email protected] or by telephone at (212)363-7500.WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.CONTACT:Levi & Korsinsky, LLPJoseph E. Levi, Esq.Ed Korsinsky, Esq.33 Whitehall Street, 17th FloorNew York, NY 10004[email protected]Tel: (212)363-7500Fax: (212)363-7171https://zlk.com/SOURCE: Levi & Korsinsky, LLP

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