Kaplan Fox is Investigating Potential Securities Law Violations against UroGen Pharma Ltd. (URGN)
CLICK HERE TO RECEIVE MORE INFORMATION ABOUT THIS INVESTIGATION
If you are a UroGen investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571.
On May 16, 2025, in advance of a meeting of the U.S. Food and Drug Administration's ('FDA') Oncologic Drugs Advisory Committee ('ODAC'), the FDA published the Combined FDA and Applicant ODAC Briefing Document concerning UroGen's new drug application ('NDA') for investigational drug UGN-102 (mitomycin) for intravesical solution for the treatment of recurrent of low-grade intermediate-risk non-muscle invasive bladder cancer ('Briefing Document'). The Briefing Document stated that 'the primary endpoints of complete response (CR) and duration of response (DOR) are difficult to interpret' as the Phase 3 ENVISION trial 'lacked a concurrent control arm.' The FDA stated that it was '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 UroGen stock declined from a closing price on May 15, 2025 of $9.85 per share, to close at $7.31 per share on May 16, 2025, a decline of $2.54 per share, or nearly 26%, on heavy trading volume.
Then, on May 21, 2025, the ODAC conducted a public meeting to discuss the NDA and then voted 4 to 5 that the benefit/risk of UGN-102 (mitomycin) for intravesical solution was favorable for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
On May 21, 2025, the price of UroGen stock declined from a closing price on May 20, 2025 of $7.54 per share to close at $4.17 per share, a decline of $3.37 per share, or over 44%, on heavy trading volume.
WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
If you have any questions about this investigation, please contact:
CONTACT:
Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(212) 329-8571
[email protected]
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
[email protected]
Contacting or submitting information to Kaplan Fox & Kilsheimer LLP does not create an attorney-client relationship, nor an obligation on the part of Kaplan Fox to retain you as a client.
https://www.kaplanfox.com/case/urogen-pharma-ltd/
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