Vertex Announces Treatment with the NaV1.8 Inhibitor VX-150 Showed Significant Relief of Acute Pain in Phase 2 Study ...

Vertex plans to submit a New Drug Application (NDA) to the FDA for VX-661 in combination with ivacaftor in the second half of 2017, pending data from the Phase 3 program.

The cell therapy in VX-264 is zimislecel (formerly VX-880). A separate Vertex program is evaluating zimislecel as a “naked” cell therapy — without encapsulation in a protective medical device.

Vertex plans to conduct two 24-week Phase 3 studies to support approval of the combination of VX-809 and ivacaftor in people with CF ages 12 and older.

Vertex plans to conduct two 24-week, randomized, double-blind, placebo-controlled Phase 3 studies of VX-809 in combination with ivacaftor. TRAFFIC and TRANSPORT will each enroll approximately 500 ...