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Stock Market & Financial Investment News

News Breaks
June 30, 2014
16:07 EDTVRTXVertex submits sNDA to FDA for Kalydeco
Vertex Pharmaceuticals announced the submission of a supplemental New Drug Application, or sNDA, to the FDA for the approval of Kalydeco in people with cystic fibrosis, or CF, ages 18 and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene. In the United States, Kalydeco is currently approved for use in people with CF ages 6 and older who have one of the following nine mutations: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D. CF is caused by a defective or missing CFTR protein that results from mutations in the CFTR gene. In the United States, approximately 300 people have the R117H mutation and are 18 years of age or older. R117H is the most common residual function mutation and also has a defect in the gating of the CFTR protein.
News For VRTX From The Last 14 Days
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October 28, 2014
18:42 EDTVRTXOn The Fly: After Hours Movers
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16:21 EDTVRTXVertex expects FY14 revenues $525M-$535M, consensus $551.82M
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16:18 EDTVRTXVertex reports Q3 adjusted EPS (37c), consensus (62c)
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October 22, 2014
05:37 EDTVRTXVertex approval could add 500 more patients, says Piper Jaffray
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October 21, 2014
16:49 EDTVRTXVertex: FDA Advisory Committee recommends approval of KALYDECO
Vertex Pharmaceuticals announced that the U.S. Food and Drug Administrationís Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.
15:25 EDTVRTXPanel backs approval for Vertex CF drug in R117H mutation, Bloomberg says
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15:18 EDTVRTXPanel votes Vertex CF drug safe, works for R117H mutation, Bloomberg reports
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07:11 EDTVRTXFDA Pulmonary-Allergy Drugs Advisory Committe to hold a meeting
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October 17, 2014
10:27 EDTVRTXVertex FDA panel expected to be positive at Piper Jaffray
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10:26 EDTVRTXFDA panel asked to consider benefit of Vertex drug in younger CF patients
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