UroGen: Despite ODAC Vote, Hope Remains With Targeting Of Other Cancer Subpopulation

Jun. 10, 2025 10:30 AM ETUroGen Pharma Ltd. (URGN) StockURGN6 Comments
Terry Chrisomalis
Investing Group Leader
(17min)

Summary

  • PDUFA date of June 13th 2025 by which FDA will decide upon whether or not UGN-102 should be approved for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
  • The 7 major bladder cancer markets are expected to reach $5.4 billion by 2034.
  • Company is developing anti-CTLA4 antibody UGN-301 in a phase 1 study either alone as a monotherapy or in combination to target patients with recurrent high-grade non-muscle invasive bladder cancer.
  • UroGen Pharma $200.4 million in cash as of March 31st of 2025; Delay in CRL could prompt immediate need to raise funds to continue its operations.
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I believe that UroGen Pharma (NASDAQ:URGN) is a "hold" rating ahead of its upcoming Prescription Drug User Fee Act [PDUFA]. In essence, the FDA has set a date to review by the regulatory application of UGN-102 [mitomycin] as intravesical

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This article was written by

Terry Chrisomalis
13.46K Followers

Terry Chrisomalis is a private investor in the Biotech sector with years of experience utilizing his Applied Science background to generate long term value from Healthcare.

He is the author of the investing group Biotech Analysis Central which contains a library of 600+ Biotech investing articles, a model portfolio of 10+ small and mid-cap stocks with deep analysis for each, live chat, and a range of analysis and news reports to help Healthcare investors make informed decisions.

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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