US biotech firm Vertex Pharmaceuticals (Nasdaq: VRTX) says it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF). Tezacaftor and ivacaftor together are already approved under the trade name Symdeko.
Shares of Vertex, already a leader in cystic fibrosis therapies, moved up 2.23% to $170.26 by close of trading on Thursday following the announcement,
Final data announced yesterday from a 24-week Phase III study in people with one F508del mutation and one minimal function mutation and from a 4-week Phase III study in people with two F508del mutations will form the basis of these submissions. Vertex previously announced that both of these Phase III studies met their primary endpoints, and the company announced the final results of these studies, including results for key secondary endpoints and safety data.
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