On Friday, PTC Therapeutics, Inc. (PTCT) revealed that the outlook for approval of its Duchenne muscular dystrophy drug in Europe had been reduced after a regulatory body “adopted a negative opinion” of the drug. PTCT stock fell almost 5% in morning trading on the news.
PTCT stock fell after the company revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had frowned on its application to obtain conditional marketing approval for ataluren. PTCT is currently conducting a Phase 3 clinical trial of ataluren among 220 patients.
Ataluren is targeted at patients suffering from nonsense mutation Duchenne muscular dystrophy. PTCT says it has been in discussions with the regulator about the drug and it “committed to completing the trial and to bringing ataluren to nmDMD patients.” PTCT says it will continue to cooperate with the EMA “in order to bring ataluren to patients as soon as possible.”
PTCT stock has risen sharply over the past year. PTCT stock hit a high of almost $30 per share earlier this month.