CHMP Issues Negative Opinion on Translarna™ Following European Commission Request for Review
PTC Therapeutics(PTCT) Prnewswire·2024-06-28 18:00- 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. PTC plans to request re-examination of the opinion. The marketing authorization for Transl ...