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Vertex Pharmaceuticals Inc (VRTX.O)

VRTX.O on Nasdaq

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2 Dec 2016
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Latest Key Developments (Source: Significant Developments)

Vertex Pharmaceuticals Inc and Parion Sciences establish collaboration to develop Epithelial Sodium Channel Inhibitors
Thursday, 4 Jun 2015 04:01pm EDT 

Vertex Pharmaceuticals Inc and Parion Sciences:Says they will collaborate to develop investigational epithelial sodium channe inhibitors for potential treatment of cystic fibrosis and other pulmonary diseases.Under the agreement, Vertex gains worldwide development and commercial rights to Parion's investigational ENaC inhibitors, including P-1037 and P-1055, for CF and other pulmonary diseases.Vertex and Parion plan to begin an additional Phase 2a study that adds P-1037 to treatment with the investigational combination of lumacaftor and ivacaftor for people with CF who have two copies of the F508del mutation.  Full Article

Vertex Pharmaceuticals receives FDA approval
Wednesday, 18 Mar 2015 07:46am EDT 

Vertex Pharmaceuticals Incorporated:Announced US Food and Drug Administration approved KALYDECO((reg))for use in children ages 2 to 5 with cystic fibrosis.Approval is based on previously announced results of an open-label Phase 3 24-week study.  Full Article

Vertex Pharmaceuticals Inc announces approval and launch of new medicines for treatment of people with Cystic Fibrosis
Sunday, 11 Jan 2015 08:40pm EST 

Vertex Pharmaceuticals Inc:Says that its New Drug Application (NDA) for the use of ivacaftor in children ages 2 to 5 who have the G551D or one of the eight additional gating mutations was accepted for filing by the Food and Drug Administration (FDA).And a target review date of March 17, 2015 was set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision.Also announced that the FDA has accepted its NDA for the combination of lumacaftor and ivacaftor in people with CF ages 12 and older who have two copies of the F508del mutation.  Full Article

Food and Drug Administration approves Vertex Pharmaceuticals Inc's KALYDECO (ivacaftor)
Monday, 29 Dec 2014 03:11pm EST 

Vertex Pharmaceuticals Inc:Says the U.S. Food and Drug Administration approved a supplemental new drug application for use of KALYDECO (ivacaftor) in people with cystic fibrosis (CF) ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene.This approval follows a recommendation by the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) to approve the medicine in this group of people with CF.KALYDECO is now approved for use in the U.S. in people ages 6 and older with CF with one of the following ten mutations: R117H, G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D.The approval is based on previously announced data from a Phase 3 study of ivacaftor that enrolled 69 people with CF ages 6 and older who had the R117H mutation.  Full Article