Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Given A Negative Opinion On The Conversion Of The Conditional Approval To Full Approval Of PTC Therapeutics' Translarna (Ataluren) For Nonsense Mutation Duchenne Muscular
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The Committee for Medicinal Products for Human Use of the European Medicines Agency has given a negative opinion on the conversion of the conditional approval to full approval of PTC Therapeutics' Translarna. The negative opinion also applies to the renewal of the existing conditional authorization. PTC plans to submit a request for re-examination and Translarna will remain on the market until the re-examination process is completed.
September 15, 2023 | 10:03 am
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PTC Therapeutics' Translarna has failed to get full approval from the European Medicines Agency, which could potentially impact the company's stock negatively in the short term.
The negative opinion from the European Medicines Agency on PTC Therapeutics' Translarna could potentially lead to a decrease in the company's stock price in the short term. This is due to the potential impact on the company's revenues and market position. However, the company plans to submit a request for re-examination, which could potentially reverse this impact if successful.
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