CHMP Issues Negative Opinion for Renewal of Conditional Marketing Authorization for Translarna™ (ataluren) Following Re-examination Procedure

January 25, 2024

https://www.prnewswire.com/news-releases/chmp-issues-negative-opinion-for-renewal-of-conditional-marketing-authorization-for-translarna-ataluren-following-re-examination-procedure-302045154.html

SOUTH PLAINFIELD, N.J., Jan. 25, 2024 /PRNewswire/ — PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion following the re-examination procedure for the conditional marketing authorization of Translarna™ (ataluren).

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