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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.
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July 31, 2014
16:42 EDTVRTXVertex receives European approval for KALYDECO in eight gating mutations
Vertex Pharmaceuticals announced that the European Commission has approved KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. KALYDECO was first approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which is the most common gating mutation. The eight additional gating mutations included in today’s approval are G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250 people ages 6 and older have one of these non-G551D gating mutations.
July 29, 2014
16:23 EDTVRTXVertex reports Q2 EPS (68c), consensus (72c)
Reports Q2 revenue $138M, consensus $132.06M.
15:53 EDTVRTXNotable companies reporting after market close
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