PTC Therapeutics, Inc. (NASDAQ:PTCT) commenced a rolling submission of a New Drug Application Print E-mail
By Marilyn Mullen   
Wednesday, 24 December 2014 10:49

PTC Therapeutics, Inc.(NASDAQ:PTCT) had announced that it has commenced a rolling submission of a New Drug Application to the United States Food and Drug Administration (FDA) for the treatment of nonsense mutation Duchenne muscular dystrophy.

A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. PTC expects to finalize the application in the fourth quarter of 2015 following the completion of the ACT DMD confirmatory Phase 3 clinical trial.

Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. stated that they are looking forward towards the completion of the ACT DMD confirmatory Phase 3 clinical trial so that they will be able to finalize the NDA. Gaining US approval, in addition to Translarna's European approval, will help them to make Translarna available to patients across the globe. He further said that it is their commitment to the patients, families, advocacy groups and physicians who have worked and supported PTC Therapeutics (PTCT) through many years of research and development.

Translarna is discovered and developed by PTC Therapeutics, Inc. PTC is a biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. Translarna is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as dystrophin in Duchenne muscular dystrophy.




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