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Vertex Pharma raises Kalydeco sales guidance after FDA OKs expanded use

Published 08/01/2017, 08:32 AM
© Reuters. Vertex Pharma raises Kalydeco sales guidance after FDA OKs expanded use
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  • The FDA approves the use of Vertex Pharmaceuticals' (NASDAQ:VRTX) KALYDECO (ivacaftor) for use in more than 600 people at least two years old with cystic fibrosis who have one of five residual function mutations that result in a splicing defect in CFTR gene. The FDA OK'd the use of KALYDECO in CF patients with 23 other function mutations in May.
  • KALYDECO is now approved to treat CF patients at least two years old who have one of 38 ivacaftor-responsive CFTR mutations.
  • The company raises its 2017 sales guidance for KALYDECO to $770M - 800M and its sales outlook for all CF products to $1.87B - 2.1B, including $1.1B - 1.3B for ORKAMBI.
  • VRTX is up 1% premarket, but only on 60 shares.
  • Now read: Pfizer (NYSE:PFE) Q2 revenues down 2%; earnings up 50%; non-GAAP EPS up 5%


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