uniQure therapy called failed product by FDA official, Bloomberg says

In a call with reporters, a senior FDA official said uniQure’s (QURE) gene therapy for Huntington’s disease is a failed product, Gerry Smith and Robert Langreth of Bloomberg report. The official noted uniQure needed to run a study that compared the patients getting the therapy to those who underwent a sham surgery, since this type of a placebo control has been the agency’s standard when evaluating treatments for Huntington’s, according to Bloomberg. An earlier study was a “stone-cold negative,” the person said. Shares of uniQure are off the day’s highs following the report but remain up 7%, or 65c, to $9.69 in afternoon trading.