PTC Therapeutics Says CHMP Has Issued Negative Opinion On Renewal Of Conditional Marketing Authorization Of Translarna (Ataluren) For The Treatment Of nmDMD; Opinion Follows Return Of Previously Issued Negative Opinion By European Commission For Re-review
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PTC Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the renewal of the conditional marketing authorization for Translarna (Ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). This follows a previous negative opinion by the European Commission, which was returned for re-review.
June 28, 2024 | 10:06 am
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PTC Therapeutics received a negative opinion from CHMP on the renewal of the conditional marketing authorization for Translarna, a treatment for nmDMD. This follows a previous negative opinion by the European Commission.
The negative opinion from CHMP on the renewal of Translarna's conditional marketing authorization is a significant regulatory setback for PTC Therapeutics. This could negatively impact the company's stock price in the short term due to potential delays or inability to market the drug in Europe.
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