Savient faces US delay for gout candidate
This article was originally published in Scrip
Executive Summary
The US FDA has extended the user fee date of the BLA for Savient Pharmaceuticals' lead gout candidate, pegloticase (newly branded Krystexxa), by three months to July 30th, after requesting extra information and data analysis. It also said that an advisory panel meeting that was previously scheduled for March 5th will now be rescheduled. The announcement sent the company's share price down by 19% to close at $5.94 on Nasdaq on February 13th.