Vertex discloses Phase II CF miss

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) disclosed in its 2Q14 earnings late Tuesday that lumacaftor ( VX-809) plus Kalydeco ivacaftor missed the primary endpoint vs. placebo in a 125-patient Phase II trial in CF patients with one copy of the delta F508 CF transmembrane conductance regulator ( CFTR) mutation (p=0.5978). Next quarter, the company plans to submit an NDA to FDA and MAA to EMA for the combination for CF patients with two copies of the delta F508 CFTR mutation (see BioCentury, June 30). ...