Re: Stock Halted Ahead of Today's T-Rex FDA Meeting
Geri any thoughts on the safety profile?
FDA advisory committee meeting for its thyroid eye disease drug teprotumumab scheduled for Friday. The adcomm document released today is "not negative, but raises some questions" according to Cantor Fitzgerald's Louise Chen. Safety seems to be a main point of interest The first two discussion topics center around potential safety concerns with repeated courses of treatment and whether there should be any special safety limitations or labeling. The FDA notes that, after HZNP’s drug was filed for approval, there was an additional subject who experienced a life-threatening event (cerebral hemorrhage) during the treatment period, as well as 2 other patients reporting serious adverse events.”