Results from PTC’s ataluren study in DMD published in The Lancet … – Seeking Alpha

The Lancet has just published results from PTC Therapeutics’ (PTCT) ACT DMD study assessing Translarna (ataluren). The primary endpoint was the change from baseline in the six-minute walk test (6MWT), which it failed to beat placebo on. The company says a treatment effect was more likely to seen in patients in the transition phase of disease (baseline 6MWT distance of 300-400 meters).

An Ad Com review in the U.S. is scheduled for October 24.

Previously: Advisory committee review September 28 for PTC’s Translarna for DMD; shares up 6% premarket (June 6)

Previously: FDA to review PTC’s marketing application for DMD candidate Translarna under protest regulations; action date October 24; shares ahead 15% premarket (March 6)

Previously: PTC Therapeutics pulls Translarna DMD regulatory submission in Canada in order to include new late-stage data, review no longer expected by mid-year (March 14, 2016)


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