Vertex gains despite mixed Orkambi briefing docs

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) gained $2.36 to $127.41 on Friday despite mixed comments by FDA reviewers on Orkambi, the company's combination of lumacaftor ( VX-809) and Kalydeco ivacaftor, to treat cystic fibrosis patients homozygous for the F508 CFTR mutation. The reviewers said Orkambi had a statistically significant but "modest" 2.6-3% improvement on percent predicted forced expiratory volume in one second (ppFEV1) for the dose for which Vertex is seeking approval, but said it is "uncertain" whether the addition of lumacaftor to Kalydeco "offers an additional benefit" over Kalydeco alone. The F508 CFTR mutation is the most common mutation among CF patients.

The comments came in (see BioCentury, June 30, 2014). ...