PTC Therapeutics Says CHMP Of European Medicines Agency Maintained Its Negative Opinion On Renewal Of Conditional Marketing Authorization Of Translarna For Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy
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PTC Therapeutics announced that the CHMP of the European Medicines Agency maintained its negative opinion on the renewal of the conditional marketing authorization for Translarna, a treatment for nonsense mutation Duchenne Muscular Dystrophy. The decision will be reviewed by the European Commission in about 67 days.
October 18, 2024 | 10:38 am
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PTC Therapeutics faces a regulatory challenge as the CHMP maintains a negative opinion on Translarna's marketing authorization renewal. The European Commission will review this decision in 67 days.
The CHMP's negative opinion on Translarna's marketing authorization renewal is a significant regulatory hurdle for PTC Therapeutics. This decision impacts the company's ability to market Translarna in Europe, potentially affecting its revenue and market position. The European Commission's upcoming review adds uncertainty to the situation.
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