PTC Therapeutics' Translarna faces withdrawal in Europe after CHMP negative opinion on renewal

PTC THERAPEUTICS, INC.

CHMP issued negative opinion on renewal of conditional marketing authorization for Translarna (ataluren) after re-examination procedure.
Negative opinion applies to Translarna for nonsense mutation Duchenne Muscular Dystrophy (nmDMD).
European Commission to adopt the opinion within 67 days, resulting in withdrawal of Translarna in Europe.
CEO Matthew B. Klein expressed disappointment, stating decision is against patient community and expert physicians.

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