10:52 AM EDT, 10/30/2024 (MT Newswires) -- PTC Therapeutics ( PTCT ) said Wednesday the US Food and Drug Administration has accepted for review the resubmission of its new drug application for Translarna to treat nonsense mutation Duchenne muscular dystrophy.

The resubmission follows a complete response letter to a new drug application that was filed over a protest in 2016, the company said, adding that the FDA hasn't provided an action date accordingly.

Duchenne is a rare and fatal genetic disorder that mainly affects males and leads to progressive muscle weakness from early childhood, PTC said.

The company's shares were down nearly 2% in recent trading.

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