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Vertex Pharmaceuticals Inc (VRTX.O)

VRTX.O on Nasdaq

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18 Jan 2017
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Latest Key Developments (Source: Significant Developments)

Vertex Pharmaceuticals Inc receives CHMP Positive Opinions for ORKAMBI (lumacaftor/ivacaftor) and KALYDECO (ivacaftor) in the European Union
Friday, 25 Sep 2015 07:17am EDT 

Vertex Pharmaceuticals Inc:Receives CHMP Positive Opinions for ORKAMBI (lumacaftor/ivacaftor) and KALYDECO (ivacaftor) in the European Union.CHMP recommends Marketing Authorization for lumacaftor in combination with ivacaftor for people with cystic fibrosis ages 12 and older with two copies of the F508del mutation.CHMP recommends Marketing Authorization for ivacaftor for children with cystic fibrosis ages 2 to 5 with 9 gating mutations & for people with cystic fibrosis ages 18 and older with the R117H mutation.European Union Committee for Medicinal Products for Human Use (CHMP) issued a positive Opinion recommending Marketing Authorization of ORKAMBI.  Full Article

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 issues revenue outlook for cystic fibrosis treatments

Vertex Pharmaceuticals Inc said on Sunday that it expected full-year 2017 revenue from its Orkambi cystic fibrosis treatment of $1.1 billion to $1.3 billion and revenue from its Kalydeco treatment of $690 million to $710 million.