Anti-AChR antibody negative (“seronegative”) gMG PDUFA is
Management to host conference call today at
“argenx continues to deliver meaningful impact for patients, reflected by our 17th consecutive quarter of VYVGART growth,” said
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
- 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 inAsia with the establishment of an argenx affiliate inChina 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 | ||||||
| (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
- 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
- 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
Income tax expense for the three months ended
Profit for the period of three months ended
Cash, cash equivalents and current financial assets1 consisted of
EXPECTED 2026 FINANCIAL CALENDAR
July 23, 2026 : Half Year and Second Quarter 2026 Financial Results and Business UpdateOctober 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
Dial-in numbers:
Please dial in 15 minutes prior to the live call.
Belgium 32 800 50 201
France 33 800 943355
Netherlands 31 20 795 1090
United States 1 888 415 4250
Japan 81 3 4578 9081
Switzerland 41 43 210 11 32
About VYVGART
VYVGART® (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and for primary immune thrombocytopenia (ITP) in
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.
This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
For further information, please contact:
Media:
bpetok@argenx.com
Investors:
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Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “advance,” “aim,” “commit,” “continue,” “drive,” “is,” “potential,” “reinforce,” “represent,” and “will,” and include statements argenx makes concerning its belief in VYVGART’s potential to become the first and only approved therapy across MG, pending FDA decisions on label expansions into seronegative and ocular populations; its extension of its leadership in FcRn into rheumatology, beginning with myositis; the progression of its next pipeline candidate, empasiprubart, towards its first registrational readout in MMN; its advancement of a broad and differentiated pipeline; its focus on delivering transformative outcomes for patients while creating sustained value for all stakeholders; its advancement of 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; driving broad adoption as the leading precision biologic in MG and CIDP while advancing multiple label expansions; its belief that it is also shaping the future of FcRn medicines by advancing new pipeline candidates and delivery modalities; the Prescription Drug User Fee Act (PDUFA) target action date of
Alternative Performance Measures Statement
In this document, argenx's financial results are provided in accordance with IFRS® Accounting Standards (IFRS) and using a non-IFRS financial measure, cash, cash equivalents and current financial assets.
This value should not be viewed as a substitute for the company’s IFRS financial information and is provided as a complement to financial information provided in accordance with IFRS and should be read in conjunction with the most directly comparable IFRS financial information as set out below. Management believes this non-IFRS financial measure is useful for securities analysts, investors and other interested parties to gain a more complete understanding of the company's available financial liquidities given that the company’s current financial assets are held in term accounts with an initial maturity of more than three months but less than twelve that may be used to meet its financial obligations. Such non-IFRS financial information, as calculated herein, may not be comparable to similarly named measures used by other companies and should not be considered comparable to IFRS financial measures. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, an analysis of the company's financial results as reported under IFRS.
A reconciliation of the IFRS financial information to non-IFRS financial information is included below:
Cash, cash equivalents and current financial assets totaled
1 A non-IFRS Alternative Performance Measure (APM). Refer to the “Alternative Performance Measures Statement” below for a reconciliation to the IFRS financial information.
FY 2018 Business Update & Financial Results