PTC faces a de­lay in Eu­rope for con­tro­ver­sial Duchenne drug

PTC Ther­a­peu­tics won’t be get­ting a de­ci­sion soon from Eu­ro­pean reg­u­la­tors on its ef­fort to get an ex­ten­sion of its con­di­tion­al ap­proval for Translar­na (ataluren) as a treat­ment for Duchenne mus­cu­lar dy­s­tro­phy. The biotech an­nounced this morn­ing that the reg­u­la­to­ry as­sess­ment won’t be com­plet­ed mid-year, adding that ex­ecs ex­pect “that Translar­na’s cur­rent mar­ket­ing au­tho­riza­tion sta­tus will re­main valid un­til a de­ci­sion is adopt­ed by the Eu­ro­pean Com­mis­sion.”

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