Shares in PTC Therapeutics plunge following FDA Refuse to File letter

23 February 2016

Shares in US pharma company PTC Therapeutics (Nasdaq: PTCT) plunged more than 50% after the company received a Refuse to File letter from the US Food and Drug Administration regarding the company’s new drug application for Translarna (ataluren).

Translarna is an oral, first-in-class, protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

The FDA stated in its letter that the application was not sufficiently complete to permit substantive review.

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