argenx Reports $1.3B Q1 2026 Revenue, PDUFA Date Set for May 10 in Seronegative gMG
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
argenx SE (Euronext & Nasdaq: ARGX) reported $1.3 billion in global product net sales for the first quarter of 2026, representing 63% year-over-year growth. The company also announced that the Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) generalized myasthenia gravis (gMG) is May 10, 2026.
The company generated $1.3 billion in global product net sales in the first quarter of 2026, an increase of approximately $0.5 billion year-over-year. This marks the 17th consecutive quarter of VYVGART growth. For the full year 2025, argenx reported $4.2 billion in global product net sales, representing 90% year-over-year growth, and delivered $1.1 billion in operating income, marking its first year of operating profitability.
VYVGART (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications: generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan.
Positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART SC pre-filled syringe for ocular myasthenia gravis (oMG) were recently presented at AAN. The primary endpoint was met (p=0.012), demonstrating statistically significant improvement from baseline in Myasthenia Impairment Index Patient Reported Outcome ocular scores at Week 4 in treated patients compared to placebo, with no new safety concerns identified. These data support a planned sBLA submission to expand the VYVGART label into oMG.
Topline results from the ALKIVIA study (myositis) are expected in the third quarter of 2026. Topline results from the ADVANCE-NEXT study (primary ITP) are expected in the first half of 2027. A registrational study in Graves' disease is expected to initiate in 2026. Topline results from the UNITY study (Sjogren's disease) are expected in the second half of 2027. The VYVGART SC autoinjector is expected to launch in 2027 for all approved indications.
The company is advancing two future FcRn molecules: ARGX-213 is Phase 3-ready and ARGX-124 is in Phase 1.
Empasiprubart, a first-in-class humanized monoclonal antibody designed to inhibit complement factor C2, is being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG. Topline results from the EMPASSION study (MMN) are expected in the fourth quarter of 2026, and topline results from the EMVIGORATE and EMNERGIZE studies (CIDP) are expected in the second half of 2027.
By the end of 2026, the argenx pipeline is expected to include a total of ten molecules in clinical development. Beyond efgartigimod and empasiprubart, this includes adimanebart (a MuSK agonist), ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6), and three additional molecules from the Immunology Innovation Program. The adimanebart CMS registrational study is on track to start in the third quarter of 2026. A Phase 2 study of ARGX-121 in IgA nephropathy is expected to start in 2026. Three new first-in-class molecules are on track to enter Phase 1 in 2026, including ARGX-118 (Galectin-10 inhibitor), ARGX-125 (bispecific antibody), and TSP-101, the Fn14-targeting program from the Tensegrity research collaboration.
argenx continues to advance its 'Vision 2030,' anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into Phase 3 development by 2030.