PTC Therapeutics falls after withdrawing muscle disorder drug marketing application

Shares of PTC Therapeutics PTCT.O fall 5.2% to $67.05 after markets

Co says it has withdrawn its marketing application resubmission for its muscle disorder drug Translarna

"FDA shared that based on its review to date, the data in the NDA submission are unlikely to meet the agency's threshold of substantial evidence of effectiveness to support approval of Translarna", says PTCT

Last year co said the drug will no longer be available for sale in the EU as the European Commission has decided not to renew its marketing authorization

The drug is designed to boost production of a protein called dystrophin, the absence of which causes muscle weakening in patients with Duchenne muscular dystrophy

PTCT was up 68.3% in 2025