argenx Q3 2026 results: VYVGART sales $1.7B; empasiprubart and FB102 advance
- VYVGART global product net sales were $1.7 billion in Q3 2026, up 54% year‑over‑year and 13% quarter‑over‑quarter.
- sBLA for VYVGART Hytrulo in IMNM on track for year‑end 2026 submission; pediatric gMG sBLA accepted with PDUFA in February 2027; autoinjector expected H2 2027.
- Topline Phase 3 empasiprubart (MMN) data expected December 2026, with CIDP Phase 3 readouts anticipated H2 2027.
- argenx reported Q3 profit of $506 million, cash and current financial assets of $3.7 billion as of Sept 30, 2026, and now expects combined R&D and SG&A ≈$4 billion for 2026.
Financial results
Product net sales of VYVGART were $1.7 billion in Q3 2026, up 54% year‑over‑year and 13% quarter‑over‑quarter. Profit for the quarter was $506 million and $1.344 billion for the nine months. Cash, cash equivalents and current financial assets totaled $3.7 billion as of September 30, 2026, after paying approximately $2.1 billion for the acquisition of Forte Biosciences Inc. Combined R&D and SG&A are now expected to be approximately $4 billion for full‑year 2026.
VYVGART commercial and regulatory progress
VYVGART remains the core commercial franchise with approvals in gMG and CIDP (and ITP in Japan). argenx submitted an sBLA for ocular myasthenia gravis and had a pediatric gMG sBLA accepted for priority review with a PDUFA target in February 2027. VYVGART Hytrulo autoinjector is expected to launch in the second half of 2027.
Empasiprubart and registrational timeline
Empasiprubart (anti‑C2) is in Phase 3 for MMN and CIDP; topline EMPASSION (MMN) results are expected in December 2026, with CIDP Phase 3 readouts from EMVIGORATE and EMNERGIZE anticipated in the second half of 2027. A Phase 2 ADAPT‑Forward platform study in gMG is ongoing to evaluate combination and monotherapy approaches.
Next‑wave immunology pipeline
argenx is advancing multiple programs beyond FcRn and empasiprubart, including FB102 (advancing to Phase 3 in celiac disease), adimanebart (Phase 3 in CMS planned), ARGX‑121 (IgA nephropathy Phase 2), and early‑stage programs ARGX‑109, TSP‑101, ARGX‑118 and ARGX‑125. The company highlights investment in registrational programs and next‑generation FcRn candidates ARGX‑213 and ARGX‑124.
Source: argenx