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PTC Therapeutics Pulls FDA Application for Muscular Dystrophy Treatment

Provided by Dow Jones Feb 12, 2026, 11:54:00 PM

By Elias Schisgall

PTC Therapeutics withdrew a New Drug Application for Translarna, a muscular dystrophy treatment, after the Food and Drug Administration indicated it would likely not grant approval.

"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," Chief Executive Officer Matthew Klein said Thursday. "We have therefore made the decision to withdraw the NDA submission."

The company had been developing Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy.

Shares of PTC fell 5.2% to $67.05 in post-market trading after closing at $70.70. The stock has gained 44% in the past year.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

February 12, 2026 18:54 ET (23:54 GMT)

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