VRTX · Earnings call · 2026Q3T · Full report

Regulatory Approval Milestones

VERTEX PHARMACEUTICALS INC / MA · 2026-11-02 · Importance 34 · Surprise 42

Vertex reported that CASGEVY was approved for patients ages 2–11 in the U.S., UAE, and Bahrain, and ages 5–11 in the U.K. The company initiated global submissions for ALYFTREK approval in children ages 2–5. For povetacicept, Vertex's U.S. PDUFA date is November 30, 2026, and the company has completed a filing for potential accelerated approval in Saudi Arabia, where the therapy has breakthrough status; it plans submissions in Europe and Asia when the study completes and two-year eGFR data are available.

Key facts

• Vertex initiated global submissions for ALYFTREK approval in children ages 2-5.
• Vertex received CASGEVY approval for patients ages 2-11 in the U.S., UAE, and Bahrain, and ages 5-11 in the U.K.