efgartigimod — Topline data
H2 2026
Topline results from UplighTED studies expected in second half of 2026Source filing
ARGX biotech catalysts & pipeline
ARGENX SE · Data as of 2026-10-25
Upcoming catalysts
FB102 — Clinical data readout
H2 2026
A Phase 2 celiac disease study has been initiated with data expected in the second half of 2026.Source filing
ARGX-124 — Full data
Late 2026
ARGX-124 expected to complete Phase 1 by end of 2026Source filing
VYVGART (efgartigimod alfa-fcab) — NDA/BLA submission
Late 2026
Reported positive Phase 3 ALKIVIA results with consistent and clinically meaningful treatment effects observed across immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM); sBLA for VYVGART Hytrulo in IMNM on track for submission by year-end 2026, supported by Breakthrough Therapy Designation, with plans to conduct an additional registrational study in DM.Source filing
VYVGART IV — Regulatory decision
Late 2026
Submitted supplemental Biologics License Application (sBLA) for VYVGART IV for anti-acetylcholine receptor antibody negative gMG (MuSK+, LRP4+ and triple seronegative); if approved, launch expected by end of 2026Source filing
efgartigimod — Topline data
Q4 2026
• Topline results expected for primary ITP (ADVANCE-NEXT) in fourth quarter of 2026Source filing
empasiprubart — Topline data
Dec 2026
Topline results from the Phase 3 EMPASSION study (MMN) expected in December 2026Source filing
efgartigimod — Topline data
2027
topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027Source filing
VYVGART (efgartigimod alfa-fcab) — Topline data
H1 2027
Topline results from Phase 3 ADVANCE-NEXT study in primary ITP expected in first half of 2027Source filing
VYVGART and VYVGART Hytrulo — PDUFA
Feb 2027
sBLA for VYVGART and VYVGART Hytrulo in pediatric gMG accepted for priority review by the FDA, with a PDUFA target action date in February 2027Source filing
efgartigimod — Topline data
H2 2027
Topline results are expected in the second half of 2027.Source filing
empasiprubart — Topline data
H2 2027
Topline results from Phase 3 EMVIGORATE and EMNERGIZE studies in CIDP anticipated in the second half of 2027Source filing
VYVGART (efgartigimod alfa-fcab) — Topline data
H2 2027
Topline results from registrational UNITY study (Sjogren's disease) expected in second half of 2027Source filing
efgartigimod — Conference presentation
Nov 11
Date: Wednesday, November 11, 9:15 – 9:30 a.m. ETSource filing