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PTC Therapeutics Announces European Commission Returns Translarna Opinion to CHMP For Re-evaluation

Author: Benzinga Newsdesk | May 20, 2024 07:04am

PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today that the European Commission (EC) has decided not to adopt the CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna™ (ataluren) and has returned the opinion to the CHMP for re-evaluation. As a result, Translarna remains on the market and available for patients in Europe consistent with its current marketing authorization. The EC has asked the CHMP to further consider the totality of evidence, including data from patient registries and real-world evidence, in a revised opinion.

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