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Vertex Pharmaceuticals (MA) (VRTX) Announces Recent Progress and Upcoming Milestones in Research and Development Programs for Cystic Fibrosisv


10/17/2013 10:09:40 AM

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SALT LAKE CITY--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided a comprehensive update on recent progress in its research and development activities in cystic fibrosis (CF) aimed at helping more people with CF and enhancing the clinical benefit for these patients with our approved and investigational medicines. Vertex today announced that the TRAFFIC and TRANSPORT Phase 3 studies of lumacaftor (VX-809) in combination with ivacaftor in people with two copies of the F508del mutation are fully enrolled. Data from these studies are expected in mid-2014, and Vertex plans to submit a New Drug Application (NDA) in the U.S. and a Marketing Authorization Application (MAA) in Europe in the second half of 2014 for the combination of lumacaftor and ivacaftor. Vertex also today provided updates on multiple ongoing label-expansion studies for ivacaftor, ongoing and planned Phase 2 combination studies of lumacaftor and ivacaftor and VX-661 and ivacaftor, and research efforts aimed at beginning clinical development of a next-generation corrector.

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