Vertex said the U.S. Food and Drug Administration approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) on December 20, 2024.

8-KRegulation FD DisclosureFiled Dec 20, 2024Period of report Dec 20, 2024Summary published (UTC) Oct 24, 2026

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Vertex said the U.S. Food and Drug Administration approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) on December 20, 2024.
The company said ALYFTREK was approved to treat cystic fibrosis in people 6 years of age and older who have at least one F508del mutation or another mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to ALYFTREK.
Vertex said it set a wholesale acquisition cost for ALYFTREK in the United States of $370,269 on an annual basis ($28,404 per 28-day pack).
The company said it filed this disclosure under Item 7.01, Regulation FD Disclosure, and that the information is not deemed filed under Section 18 of the Securities Exchange Act of 1934.

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Analysis scope · Filing bodyWe analyzed the filing body and confirmed exhibits. This is not a review of other exhibits, investor presentations or the full earnings call.

U.S. FDA Approval of ALYFTREK

Vertex said the U.S. Food and Drug Administration approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) on December 20, 2024.

Source · Based on the filing body and exhibits

Approved Indication and Eligible Age Group

The company said ALYFTREK was approved to treat cystic fibrosis in people 6 years of age and older who have at least one F508del mutation or another mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to ALYFTREK.

Source · Based on the filing body and exhibits

U.S. Wholesale Acquisition Cost Set

Vertex said it set a wholesale acquisition cost for ALYFTREK in the United States of $370,269 on an annual basis ($28,404 per 28-day pack).

Source · Based on the filing body and exhibits

Nature of Item 7.01, Regulation FD Disclosure

The company said it filed this disclosure under Item 7.01, Regulation FD Disclosure, and that the information is not deemed filed under Section 18 of the Securities Exchange Act of 1934.

Source · Based on the filing body and exhibits

AI summarized the filing and translated the summary into English; it may differ from the original. For reference only, not investment advice. AI translated the published Korean report into English. Figures are copied as filed, not recalculated.

Original filing

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