zimislecel — NDA/BLA submission
2026
We expect global regulatory submissions for zimislecel in 2026.Source filing
VRTX biotech catalysts & pipeline
VERTEX PHARMACEUTICALS INC · Data as of 2026-09-08
Upcoming catalysts
VX-522 — Interim data
H2 2026
Vertex is targeting completion of dosing in the multiple ascending dose (MAD) portion of the Phase 1/2 study of VX-522 and disclosure of the data in the second half of 2026.Source filing
VX-670 — Topline data
H2 2026
Vertex is on track to complete dosing in the trial and share results in the second half of 2026.Source filing
VX-828 — Topline data
H2 2026
Vertex completed dosing in this study and is on track to share results in the second half of 2026.Source filing
inaxaplin — Topline data
this fall
AMPLIFIED is a study of inaxaplin in people with AMKD with moderate proteinuria, and people with AMKD and Type 2 diabetes — populations not being studied in the AMPLITUDE trial.Source filing
povetacicept — PDUFA
Nov 30
The FDA accepted our biologics license application for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.Source filing
inaxaplin — Interim data
early 2027
We expect to share data from the interim analysis of the AMPLITUDE clinical trial in early 2027.Source filing