Credit Suisse Upgrades PTC Therapeutics (PTCT) to Outperform; ROW Translarna Sales Risk Off the Table
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CHMP Recommends Renewal of Translarna's™ Marketing Authorization for Nonsense Mutation Duchenne Muscular Dystrophy Based on Continued Positive Benefit-Risk Assessment
November 11, 2016 7:15 AM ESTSOUTH PLAINFIELD, N.J., Nov. 11, 2016 /PRNewswire/ --Â PTC Therapeutics, Inc. (NASDAQ: PTCT) today 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.
"We are pleased with this outcome which took into... More
