EC conditionally approves PTC's Translarna

The European Commission granted conditional marketing authorization to Translarna ataluren from PTC Therapeutics Inc. (NASDAQ:PTCT) to treat nonsense mutation Duchenne muscular dystrophy (DMD). As a condition of the approval, PTC will need to complete its confirmatory Phase III trial, from which the company expects to report top line-data in mid-2015.

In May, EMA's CHMP reversed a prior negative opinion on Translarna for the indication (see BioCentury Extra, May 23). ...