STOCKWATCH: EU conditional approvals – what gives?
This article was originally published in Scrip
Executive Summary
The adjectives used to describe PTC Therapeutics' conditional European approval for its drug Translarna (ataluren) for Duchenne muscular dystrophy ranged from 'surprise' to 'historic' and helped to bolster PTC's share price by 30% by the close of the day of the announcement (scripintelligence.com, 23 May 2014). PTC's regulatory success was certainly unexpected as it followed a previous rejection by CHMP which cited limited evidence of Translarna's efficacy (scripintelligence.com, 24 January 2014).