CHMP Issues Negative Opinion on Translarna™ Following European Commission Request for Review

June 28, 2024

https://www.prnewswire.com/news-releases/chmp-issues-negative-opinion-on-translarna-following-european-commission-request-for-review-302185263.html

– PTC to submit a request for re-examination –

WARREN, N.J., June 28, 2024 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the CHMP has issued a negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nmDMD. This opinion follows the return of the previously issued negative opinion by the European Commission (EC) for re-review.

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