Translarna gains renewal of conditional marketing approval by EMA/CHMP

12 November 2016

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) completed its scientific assessment of the annual renewal of the conditional marketing authorization for Translarna (ataluren) and recommended that this be renewed.

The news that Translarna will now remain on the marker for at least five more years saw the shares of PTC Therapeutics (Nasdaq: {TCT), maker of the Duchenne muscular dystrophy (DMD) drug, nearly double in price to $11.80 in Friday premarket trading.

In August 2014, PTC Therapeutics secured conditional approval in Europe based on a Phase III study which failed to demonstrate a conclusive benefit for Duchenne patients. Most recently, the company had warned investors that European regulators were leaning towards not renewing Translarna's conditional approval, so Friday's decision came as a surprise, according to a posting on TheStreet blog.

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