FDA panel to review PTC's Translarna for DMD

PTC Therapeutics Inc. (NASDAQ:PTCT) said FDA's Peripheral and Central Nervous System Drugs Advisory Committee will meet on Sept. 28 to discuss the company's NDA for Translarna ataluren to treat nonsense mutation Duchenne muscular dystrophy (nmDMD).

PTC submitted its NDA for Translarna over protest in March. FDA acknowledged receipt and granted standard review to the NDA, with a PDUFA date of Oct. 24 (see BioCentury Extra, March 6)...