PTC falls after FDA refuses Translarna NDA

PTC Therapeutics Inc. (NASDAQ:PTCT) sank $17.42 (62%) to $10.84 on Tuesday after it said FDA issued a refusal to file letter for its NDA for Translarna ataluren to treat nonsense mutation Duchenne muscular dystrophy (DMD).

The agency wrote that the NDA was not sufficiently complete to permit a substantive review, according to PTC. The company declined to comment on FDA's reason, and said it is reviewing the letter to determine its next steps for the small molecule that facilitates complete translation of proteins containing nonsense mutations. ...