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Biotech Stocks Facing FDA Decision In August

Vertex Pharmaceuticals
Vertex Pharmaceuticals

The FDA decision on Vertex Pharmaceuticals Inc.’s (VRTX) supplemental New Drug Application seeking approval of Ivacaftor in children with cystic fibrosis aged 12 to less than 24 months is expected to be announced on August 15, 2018.

Ivacaftor, under brand name Kalydeco, is already approved for the treatment of cystic fibrosis in patients age 2 years and older who have one mutation in the CFTR gene that is responsive to Ivacaftor.

Kalydeco generated annual revenue of $844.6 million in 2017 compared to $703.4 million in 2016.

VRTX closed Wednesday’s (Jul 25) trading at $176.81, up 1.10%.