On May 7, 2026 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its first quarter 2026 results and provided a business update.

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"argenx continues to deliver meaningful impact for patients, reflected by our 17th consecutive quarter of VYVGART growth," said Karen Massey, Chief Executive Officer of argenx. "Looking ahead, VYVGART has the potential to become the first and only approved therapy across MG, pending FDA decisions on label expansions into seronegative and ocular populations. At the same time, we are extending our leadership in FcRn into rheumatology, beginning with the upcoming myositis readout. Our next pipeline candidate, empasiprubart, is progressing toward its first registrational readout in MMN, and we continue to advance a broad and differentiated pipeline. With these opportunities, we remain focused on delivering transformative outcomes for patients while creating sustained value for all stakeholders."

Vision 2030

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.

Expanding global VYVGART opportunity and shaping the long-term future of FcRn

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, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. argenx is driving broad adoption as the leading precision biologic in MG and CIDP while advancing multiple label expansions. argenx is also shaping the future of FcRn medicines by advancing new pipeline candidates and delivery modalities.

Generated $1.3 billion in global product net sales in the first quarter of 2026, representing an increase of approximately 63% or $0.5 billion in year-over-year growth
Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026
Positive topline results from ADAPT OCULUS were recently presented at AAN; these data support planned sBLA submission to expand VYVGART label into oMG
Topline results from ALKIVIA study (myositis) expected in third quarter of 2026
Topline results from ADVANCE-NEXT study (primary ITP) expected in first half of 2027
Registrational study in Graves’ disease (GD) expected to initiate in 2026, expanding development into thyroid-driven autoimmunity
Topline results from UNITY study (Sjogren’s disease) expected in second half of 2027
VYVGART SC autoinjector expected to launch in 2027 for all approved indications
Progressing two future FcRn molecules: ARGX-213 is Phase 3-ready and ARGX-124 is in Phase 1

Advancing empasiprubart

Empasiprubart is a first-in-class, humanized monoclonal antibody designed to inhibit complement factor C2, selectively blocking activation of the classical and lectin complement pathways. It 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 EMPASSION study (MMN) expected in fourth quarter of 2026
Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027
Decision for Phase 2 VARVARA study (Delayed Graft Function) expected mid-year 2026 following completion of 52-week efficacy analysis
ADAPT-Forward combination study ongoing to evaluate empasiprubart as an add on therapy to efgartigimod in gMG
Delivering next wave of immunology innovation

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 (IIP). Collectively, these programs support argenx’s goal of launching, on average, one new pipeline candidate per year.

Adimanebart CMS registrational study on track to start in third quarter of 2026
Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026
Three new first-in-class molecules 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

Key business highlights

On May 6, 2026, Karen Massey was appointed Chief Executive Officer and executive director of the argenx Board of Directors following the Annual General Meeting of Shareholders. Tim Van Hauwermeiren was appointed non-executive director and Chairperson of the Board of Directors
In March 2026, argenx expanded its global presence in Asia with the establishment of an argenx affiliate in China to broaden its access to novel biology and support early-stage research
FIRST QUARTER 2026 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended
March 31,
(in millions of $ except for per share data) 2026 2025
Product net sales $ 1,298 $ 790
Other operating income* 15 17
Total operating income 1,313 807

Cost of sales $ (121) $ (81)
Research and development expenses* (443) (311)
Selling, general and administrative expenses (355) (276)
Total operating expenses (919) (668)

Operating profit $ 394 $ 139

Financial income $ 44 $ 37
Financial expense (1) (1)
Exchange (losses)/gains (11) 27

Profit for the period before taxes $ 426 $ 202
Income tax expense $ (60) $ (33)
Profit for the period $ 366 $ 169
Profit for the period attributable to:
Owners of the parent $ 366 $ 169
Weighted average number of shares outstanding 62,056,886 60,983,325
Basic profit per share (in $) $ 5.90 $ 2.78
Weighted average number of shares outstanding for diluted profit per share 66,356,591 65,664,300
Diluted profit per share (in $) $ 5.52 $ 2.58
*Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of: collaboration revenue and other operating income, as well as the combination of research and development expenses and loss from investment in a joint venture.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three months ended March 31, 2026, was $1.3 billion compared to $0.8 billion for the same period in 2025, and consists of:

Product net sales of VYVGART for the three months ended March 31, 2026, were $1.3 billion compared to $0.8 billion for the same period in 2025.
Other operating income for the three months ended March 31, 2026, was $15 million compared to $17 million for the same period in 2025. The other operating income primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three months ended March 31, 2026, were $0.9 billion compared to $0.7 billion for the same period in 2025, and mainly consists of:

Cost of sales for the three months ended March 31, 2026, was $121 million compared to $81 million for the same period in 2025. The cost of sales was recognized with respect to the sale of VYVGART.
Research and development expenses for the three months ended March 31, 2026, were $0.4 billion compared to $0.3 billion for the same period in 2025. The expenses mainly relate to:
Advancing efgartigimod across multiple severe autoimmune diseases;
Progressing empasiprubart into multiple indications;
Executing studies for adimanebart in rare neuromuscular diseases; and
Early-stage discovery and preclinical programs to sustain long-term pipeline growth.
Selling, general and administrative expenses for the three months ended March 31, 2026, were $0.4 billion compared to $0.3 billion for the same period in 2025. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses.

Financial income for the three months ended March 31, 2026, was $44 million compared to $37 million for the same period in 2025.

Income tax expense for the three months ended March 31, 2026, was $60 million compared to $33 million for the same period in 2025. Income tax expense for the three months ended March 31, 2026, consists of $102 million of current income tax expense and $42 million of deferred tax benefit, compared to $29 million of current income tax expense and $4 million of deferred tax expense for the comparable prior period.

Profit for the period of three months ended March 31, 2026, was $366 million compared to $169 million in 2025, representing 116% growth year-over-year. The basic profit per share was $5.90 for the three months ended March 31, 2026, compared to $2.78 in 2025.

Cash, cash equivalents and current financial assets1 consisted of $4.3 billion in cash, cash equivalents and $0.6 billion in current financial assets which totaled $4.9 billion as of March 31, 2026, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

EXPECTED 2026 FINANCIAL CALENDAR

July 23, 2026: Half Year and Second Quarter 2026 Financial Results and Business Update
October 22, 2026: Third Quarter 2026 Financial Results and Business Update
CONFERENCE CALL DETAILS

The first quarter 2026 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

(Press release, argenx, MAY 7, 2026, View Source [SID1234665213])