By Dean Seal
Shares of PTC Therapeutics fell after the company said regulators for the European Union won't renew authorization for its Translarna treatment for nonsense mutation Duchenne muscular dystrophy.
The stock was down 9% at $50 ahead of the market open on Friday. Shares had gained 22% year-to-date when the market closed yesterday. They were trading at $29.09 this time a year ago.
The Warren, N.J., company said before the bell that the European Commission adopted the opinion of the Committee for Medicinal Products for Human Use to remove the drug's conditional marketing authorization in the European Economic Area.
Still, the commission said individual countries within the European Union can use certain exemptions to continue using Translarna.
Chief Executive Matthew Klein said the decision is disappointing after a prolonged period of review by the European Commission.
"We look forward to working on a country-by-country basis to provide the commercial drug where possible," he said.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
March 28, 2025 09:31 ET (13:31 GMT)
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