CHMP maintains negative opinion on PTC's Translarna renewal; EC decision awaited in ~67 days

PTC THERAPEUTICS, INC.

CHMP upheld negative opinion on renewal of conditional marketing authorization for Translarna (ataluren) in nmDMD after re-examination.
European Commission expected to decide on opinion adoption in approximately 67 days; Translarna remains authorized pending EC review.
CEO cites totality of evidence from three placebo-controlled trials and STRIDE registry as supportive of continued authorization.
CHMP based decision on primary analysis subpopulation of Study 041; PTC will provide all possible evidence to EC for continued authorization.
Translarna currently authorized in Europe; PTC continues to ensure availability for nmDMD patients during review.

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