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UroGen Pharma rises after UGN-101 shows positive action in late-stage urothelial cancer study

Chief medical officer Mark P Schoenberg said the results “validated” the potential of UGN-101 to “shift the surgical treatment paradigm” and help patients
A reseracher in a lab
The Israeli biotech's products are designed to remove tumors by non-surgical means, to treat various forms of urothelial cancer, including bladder cancer

UroGen Pharma Ltd’s (NASDAQ:URGN) shares climbed Wednesday in premarket trade after the biotech said its lead drug candidate UGN-101 showed positive results in a late-stage urothelial cancer study.

The company, headquartered in Ra'anana, Israel is developing its product candidates as chemoablation agents, which are designed to remove tumors by non-surgical means, to treat various forms of non-muscle invasive urothelial cancer, including low-grade bladder cancer..

READ: QBioMed provides optimistic shareholder update

Topline results from the biotech’s Phase 3 OLYMPUS clinical trial of UGN-101 for the non-surgical treatment of low-grade upper tract urothelial cancer showed that on an intent-to-treat basis, 57% of patients achieved a complete response rate after four-to-six weeks after being treated with UGN-101

Most significantly, all evaluated patients remain disease-free at six months.

“We are pleased to report that the complete response and durability data remain consistent with the interim analysis presented in May 2018,” said Mark P Schoenberg, chief medical officer at UroGen Pharma.

“These results continue to validate the potential of UGN-101 to shift the surgical treatment paradigm and benefit patients whose only alternative would be repetitive endoscopic surgical intervention or complete loss of a kidney,” he added.

UGN-101 already enjoys Orphan Drug, Fast Track and Breakthrough Therapy status in the United States.

Shares of the biotech climbed nearly 3% to $52.30 before the opening bell.

 

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