VRTX · 10-Q · 2026Q3 · Full report

Regulatory Approval Milestones

VERTEX PHARMACEUTICALS INC / MA · 2026-11-03 · Importance 34 · Surprise 42

Vertex reported that PALSONIFY was approved in the European Union in April 2026 and expects to begin launches in European markets in the second half of 2027. Its regulatory submission in Japan was completed in April 2026, and Japan’s Ministry of Health, Labor and Welfare granted it orphan drug designation. These developments provide a defined regulatory and geographic expansion timeline for the acromegaly medicine.

Key facts

• Vertex completed the regulatory submission for PALSONIFY in Japan in April 2026, and Japan’s MHLW granted the product orphan drug designation. source
• Vertex initiated global regulatory submissions for ALYFTREK for children with CF aged two to five years. source