UroGen Pharma: ODAC Decision Puts Drug Approval In Limbo, But It's Not Over, Either

Summary

• UroGen Pharma Ltd.'s investment thesis hinges on FDA approval of UGN-102, a minimally invasive bladder cancer treatment with a June 13 decision date.
• ODAC narrowly voted against approval, citing insufficient comparative data, but a split panel and urologist support leave room for a positive FDA surprise.
• URGN faces significant financial risk, with only 4-5 quarters of cash and an inability to fund another confirmatory trial if required by the FDA.
• Despite high risk and a steep share price decline, I rate URGN stock a Buy at current levels, potentially betting on an FDA approval turnaround.

Willie B. Thomas/DigitalVision via Getty Images

Topline Summary

UroGen Pharma Ltd. (NASDAQ:URGN) is a cancer-focused developmental pharmaceutical company working to commercialize novel treatment approaches for bladder cancer. Many have been awaiting a decision from the FDA on approval, which

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in URGN over 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.