FDA accepts Marathon Pharma's NDAs for Duchenne candidate deflazacort under accelerated review

• The FDA accepts privately held Marathon Pharmaceuticals, LLC's New Drug Applications (NDAs) seeking approval of deflazacort for the treatment of Duchenne muscular dystrophy (DMD). The agency will review the applications under Priority Review status which shortens the review clock to six months from the usual 10 months.
• The company submitted two NDAs, one for an oral suspension formulation and one for an immediate-release tablet formulation.
• The FDA action date (PDUFA) should be in February 2017.
• Deflazacort is a steroid called a glucocorticoid. It is a derivative of prednisone with less side effects.
• DMD-related tickers: (SRPT -8.8%)(BMRN -1%)(SMMT)(PTCT -1.2%)(PFE -0.2%)(MRNA)