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RBC Affirms PTC Therapeutics (PTCT) at 'Sector Perform'; Doesn't See Translarna Appeal with Solid Chance

Go back to RBC Affirms PTC Therapeutics (PTCT) at 'Sector Perform'; Doesn't See Translarna Appeal with Solid Chance

PTC Therapeutics Provides Regulatory Update on Translarna™ (ataluren) for Nonsense Mutation Duchenne Muscular Dystrophy

October 17, 2016 8:00 AM EDT

SOUTH PLAINFIELD, N.J., Oct. 17, 2016 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today provided a regulatory update on Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

U.S. regulatory update

PTC Therapeutics announced today that at the end of last week, the Office of Drug Evaluation I (ODE-I) of the U.S. Food and Drug Administration (FDA) denied the company's first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products (DNP) on February 22, 2016 regarding PTC's New Drug Application (NDA)... More