CHMP issues negative opinion on Translarna full authorization; PTC to seek re-examination

PTC THERAPEUTICS, INC.

CHMP gave negative opinion on converting Translarna's conditional MA to full MA for nmDMD.
Negative opinion also applies to renewal of existing conditional authorization.
PTC will submit re-examination request; expected CHMP opinion in Jan 2024, EC ratification within 67 days.
Translarna stays on market for nmDMD patients during re-examination process.
PTC cites favorable safety profile & efficacy data from 3 placebo-controlled trials and STRIDE registry.

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