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Date Title and Summary Additional Formats
Toggle Summary Vertex Announces Positive Results from Open-Label Phase 3 Study of KALYDECO® (ivacaftor) in Children with Cystic Fibrosis Ages 1 to 2 Years
-Study met primary safety endpoint and showed improvements across multiple endpoints, including measures of pancreatic function- -Potential to modify the course of CF in children as young as one year of age- -Results support FDA and EMA filings in the first quarter of 2018- BOSTON --(BUSINESS
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Toggle Summary Vertex and CRISPR Therapeutics to Co-Develop and Co-Commercialize CTX001 as CRISPR/Cas9 Gene Edited Treatment for Sickle Cell Disease and β-Thalassemia
-Vertex selects CTX001 as first gene edited treatment to be developed as part of collaboration with CRISPR Therapeutics - -Clinical Trial Application for CTX001 submitted in Europe to support initiation of Phase 1/2 clinical study in β-thalassemia in 2018- -Preclinical data for CTX001 presented
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Toggle Summary Vertex Announces Upcoming Presentation at the J.P. Morgan Healthcare Conference and Date of Fourth-Quarter and Full-Year 2017 Financial Results
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the J.P. Morgan Healthcare Conference on Monday, January 8, 2018 at 12:30 p.m. ET ( 9:30 a.m. PT ). The audio portion of management's remarks can be accessed live through
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Toggle Summary Vertex Receives EU Approval for ORKAMBI® (lumacaftor/ivacaftor) in Children with Cystic Fibrosis Ages 6-11 with Two Copies of the F508del Mutation
- In Europe, there are approximately 3,400 children ages 6-11 who have two copies of the F508del mutation - - Existing reimbursement agreements in countries like Ireland will enable rapid access to ORKAMBI; country-by-country reimbursement processes will now begin in other countries- LONDON
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Toggle Summary Vertex Reports Full-Year and Fourth-Quarter 2017 Financial Results
-Total 2017 CF product revenues of $2.17 billion , a 29% increase compared to $1.68 billion in 2016; 2017 KALYDECO revenues of $845 million and 2017 ORKAMBI revenues of $1.32 billion - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated
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Toggle Summary Vertex Selects Two Next-Generation Correctors, VX-659 and VX-445, to Advance into Phase 3 Development as Part of Two Different Triple Combination Regimens for People with Cystic Fibrosis
- Phase 2 data showed mean absolute improvements in ppFEV 1 of up to 13.3 and 13.8 percentage points for VX-659 and VX-445, respectively, in triple combination with tezacaftor and ivacaftor in people with CF who have one F508del mutation and one minimal function mutation (F508del/Min); triple
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Toggle Summary FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene
- SYMDEKO is Vertex's third medicine to treat the underlying cause of CF - - SYMDEKO to begin shipping to pharmacies this week - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO ™
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Toggle Summary Vertex Announces Treatment with the NaV1.8 Inhibitor VX-150 Showed Significant Relief of Acute Pain in Phase 2 Study
-VX-150 was generally well tolerated and showed statistically significant relief of acute pain compared to placebo; study included an active reference arm of the opioid pain medicine hydrocodone+acetaminophen to support evaluation of VX-150 treatment effect- -Phase 2 study in acute pain is the
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Toggle Summary Vertex Initiates First Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis
-Global Phase 3 study to enroll 360 patients with one F508del mutation and one minimal function mutation- -Study designed to support submission of New Drug Application in the U.S. based on 4-week primary efficacy endpoint and 12-week safety data- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals
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Toggle Summary Vertex Appoints Reshma Kewalramani, M.D., as Chief Medical Officer
- Jeffrey Chodakewitz , M.D., to retire and serve as senior advisor through early 2019- - Dr. Kewalramani to become CMO and Executive Vice President, Global Medicines Development and Medical Affairs, on April 1, 2018 - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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