NEW YORK, NY - May 23, 2025 (NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN).
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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.
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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
jcampisi@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com
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