NasdaqGS:PTCTBiotechs
PTC Therapeutics Faces Translarna Setback While Valuation Signals Potential Upside
PTC Therapeutics, Inc. (NasdaqGS:PTCT) has withdrawn its planned resubmission of the New Drug Application for Translarna following feedback from the US Food and Drug Administration.
The decision affects Translarna's potential US path for treating patients with Duchenne muscular dystrophy caused by nonsense mutations.
The update centers on regulatory communication, not on new clinical data releases.
PTC Therapeutics focuses on therapies for rare diseases, so each regulatory decision can...