PTC Therapeutics (PTCT) Surges After CHMP Recommends Renewal of Translarna Marketing Authorization

November 11, 2016 7:24 AM EST

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PTC Therapeutics (NASDAQ: PTCT) surges 82% in pre-open trade after the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the renewal of the conditional marketing authorization of Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients five years and older. In connection with the renewal, the marketing authorization will include a specific obligation to conduct an additional long-term post-authorization trial.



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