- Q1 product net sales $1.3B (+63% YoY), profit $366M, and cash plus current financial assets $4.9B.
- PDUFA target date May 10, 2026 for anti‑AChR antibody‑negative gMG; planned sBLA after positive ADAPT OCULUS topline to expand VYVGART into ocular MG; VYVGART SC autoinjector expected 2027.
- Clinical timeline highlights: ALKIVIA (myositis) topline Q3 2026; EMPASSION (MMN) topline Q4 2026 and CIDP readouts 2H 2027; ADVANCE‑NEXT (primary ITP) 1H 2027; UNITY (Sjogren’s) 2H 2027; adimanebart CMS registrational start Q3 2026; ARGX‑121 Phase 2 IgAN start 2026; ARGX‑213 Phase 3‑ready, ARGX‑124 in Phase 1, and ARGX‑118/ARGX‑125/TSP‑101 entering Phase 1 in 2026.
Financial performance
Q1 product net sales were $1.298B (+63% YoY), total operating income $1.313B, operating profit $394M and profit for the period $366M (basic EPS $5.90). Cash, cash equivalents and current financial assets totaled $4.9B. Cost of sales $121M, R&D $443M and SG&A $355M for the quarter.
VYVGART regulatory and delivery milestones
PDUFA target action date for anti‑AChR antibody‑negative gMG is May 10, 2026; positive ADAPT OCULUS topline supports a planned sBLA to expand into ocular MG; VYVGART SC autoinjector is expected to launch in 2027.
Empasiprubart and key readouts
Empasiprubart (anti‑C2) topline timelines: EMPASSION (MMN) Q4 2026; EMVIGORATE and EMNERGIZE (CIDP) 2H 2027; VARVARA Phase 2 decision (Delayed Graft Function) expected mid‑2026 after 52‑week analysis; ADAPT‑Forward combination study with efgartigimod ongoing.
Broader pipeline and timelines
By end‑2026 the pipeline is expected to include ten clinical molecules; notable milestones: ALKIVIA (myositis) topline Q3 2026; ADVANCE‑NEXT (primary ITP) 1H 2027; UNITY (Sjogren’s) 2H 2027; adimanebart CMS registrational study on track to start Q3 2026; ARGX‑121 Phase 2 in IgAN expected 2026; ARGX‑213 is Phase‑3 ready, ARGX‑124 in Phase 1, and ARGX‑118/ARGX‑125/TSP‑101 on track to enter Phase 1 in 2026.
Corporate items
Karen Massey appointed CEO and executive director on May 6, 2026; Tim Van Hauwermeiren named non‑executive chair; argenx established an affiliate in China in March 2026. Vision 2030 targets treating 50,000 patients, 10 labeled indications and five candidates in Phase 3 by 2030.
