By Josh Beckerman
UroGen Pharma shares fell to a 52-week low after a Food and Drug Administration document indicated disagreements with the company about certain aspects of studies of bladder cancer drug UGN-102.
The stock declined 26% to $7.25 Friday and is down about 31% this year. Its intraday low was $6.46.
The FDA posted a briefing document for Wednesday's advisory committee meeting. The agency said that because the Envision trial lacked a concurrent control arm, the primary endpoints of complete response and duration of response are difficult to interpret. The agency said it recommended a randomized trial design several times.
UroGen said on April 26 that updated results from a study of UGN-102 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer "demonstrated a compelling probability of remaining in complete response of 80.6% at 18 months in patients who achieved a complete response at three months (79.6%)."
The company has noted that the existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor. "Many of these patients are elderly and face the burden of repeated surgeries under general anesthesia, highlighting the urgent need for innovative treatment options."
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
May 16, 2025 15:24 ET (19:24 GMT)
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