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PTC gains after CHMP backs Translarna renewal

November 11, 2016 11:30 PM UTC

PTC Therapeutics Inc. (NASDAQ:PTCT) gained $5.30 (88%) to $11.30 on Friday after EMA’s CHMP recommended renewal of the conditional marketing authorization for Translarna ataluren to treat Duchenne muscular dystrophy (DMD). The annual renewal had been in some doubt after CHMP requested more information about the drug last month.

CHMP said available data continue to show that Translarna slows disease progression and does not pose major safety concerns, although its benefit-risk balance is unclear without additional data. As a result, CHMP requested that PTC conduct an 18-month placebo-controlled study, followed by an 18-month open-label extension in which all DMD patients receive Translarna. CHMP expects data in 1Q21...

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