PTC Therapeutics Offers Update on Health Canada Review of Translarna for Treatment of DMD

PTC Therapeutics, Inc.

today announced that the company intends to submit the results of the recently completed Phase 3 ACT DMD study for review by Health Canada as part of the New Drug Submission (NDS) for Translarna™ (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD). In order to submit this additional data for review, PTC will withdraw the current NDS from Health Canada and resubmit the NDS with the ACT DMD results. As a result, the company no longer expects Health Canada review of the NDS in the first half of 2016.