Industry Partner News: PTC Therapeutics Receives Complete Response Letter for Ataluren's NDA


The Office of Drug Evaluation I of the U.S. Food and Drug Administration (FDA) has issued a complete response letter stating it cannot approve PTC Therapeutics, Inc.'s New Drug Application (NDA) for the investigational medicine ataluren. Ataluren, discovered and developed by PTC Therapeutics, Inc., is a protein restoration therapy designed to enable the formation of a functioning protein in patients with Duchenne caused by a nonsense mutation.For more, please see PTC Therapeutics, Inc.'s full press release or President and CEO Stuart Peltz, Ph.D.'s community letter.