PTC Shares More Than Double Following CHMP's Positive Opinion On Translarna(TM)

Shares of PTC Therapeutics

have surged an astounding 120 percent in Friday's pre-market session following the issuance of a press release earlier. About a half hour ahead of the opening bell, PTC shares last traded at $33; the stock closed at $15.32 on Thursday afternoon. The company reported the Committee for Medicinal Products for Human Use in Europe gave a positive opinion related to PTC's application for conditional marketing authorization of Translarna(TM). A source cited in the company's press release, Dr. Craig McDonald of the Physical Medicine and Rehabilitation at the University of California, Davis, said, "Translarna is the first treatment for the underlying cause of nonsense mutation DMD to receive a positive opinion from the CHMP.  The Phase 2b clinical trial provided strong evidence that Translarna slows disease progression as measured by the 6-minute walk test. A clinically meaningful 31.3 meter benefit in 6-minute walk distance, relative to placebo, was achieved in 48 weeks of treatment in patients five years and older and this was supported by positive trends in multiple secondary efficacy endpoints. In addition, in the prespecified group of patients with less than a 350 meter baseline 6-minute walk distance, a 68 meter benefit was observed in patients treated with 40 mg/kg Translarna given daily, relative to placebo." PTC said the positive opinion "will form the basis for a European Commission (EC) decision as to whether to formally grant the conditional marketing authorization. The European Commission will review the positive opinion from the CHMP and generally delivers its final decision within three months."