The FDA approved Urogen Pharma Ltd.’s mitomycin gel, an orphan drug branded Jelmyto, on April 15, offering patients the first non-surgical option for low-grade upper tract urothelial cancer (LG-UTUC) and granting the Princeton, N.J.-based company with its first marketed product.
Princeton, N.J.-based Urogen Pharma Ltd. is transforming itself into a commercial operation in anticipation of an FDA approval for UGN-101 this week. Wall Street also apparently expects a positive decision by the April 18 PDUFA date, as listed in BioWorld’s Drugs on Deck record. Urogen’s stock (NASDAQ:URGN) has climbed 40% since the month began, and 11.31%, or $2.41, on April 13, closing out the day at $23.71.