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 2026-10-25
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 — Clinical data readout
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 — Initial data
H2 2026
• Consistent with its commitment to serial innovation and bringing as many patients as possible to carrier levels of CFTR function, Vertex is evaluating VX-828, the first of the next-generation 3.0 CFTR corrector class, in a proof-of-concept study in people with CF. Vertex completed dosing in this study and is on track to share results in the second half of 2026.Source filing
inaxaplin — Initial data
this fall
• Vertex has completed enrollment and dosing in the AMPLIFIED Phase 2 study of inaxaplin and is on track to share data this fall.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