- The FDA approves the use of Vertex Pharmaceuticals' (NASDAQ:VRTX) ORKAMBI (lumacaftor/ivacaftor) for use in children ages 6 through 11 with cystic fibrosis (CF) who have two copies of the F508del mutation. It was previously approved for patients at least 12 years old. The expanded label enables access to ORKAMBI for an additional ~11K Americans.
- Separately, the company lowered its 2016 revenue guidance to $950M - 990M from $1.0B - 1.1B. ORKAMBI is expected to book $230M - 235M in sales in Q3 following sales of $223M and $245M in Q1 and Q2, respectively. The company attributes the lower expectations to a slower-than-anticipated launch of ORKAMBI in Germany, slower-than-expected ORKAMBI refills in July and August and market saturation in the U.S.
- Shares are down 2% after hours on increased volume.