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STOCKWATCH: EU conditional approvals – what gives?

 
• By Andy Smith

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).

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).

However, the recent track record of European drug approvals, especially conditional approvals such as that of PTC's Translarna, may be...

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