argenx Reports Half Year 2025 Financial Results and Provides Second Quarter Business Update
argenx (NASDAQ:ARGX) reported strong Q2 2025 financial results, with global product net sales reaching $949 million, representing 97% year-over-year growth. The company achieved $245 million in quarterly profit, with earnings per share of $4.02.
VYVGART SC launch in CIDP has gained momentum with over 2,500 patients on treatment globally. The company announced positive proof-of-concept data for ARGX-119 in CMS, advancing to a registrational study. argenx maintains its Vision 2030 goal of treating 50,000 patients globally, securing 10 labeled indications, and advancing five pipeline candidates to Phase 3.
The company's R&D and SG&A guidance remains at $2.5 billion, with six registrational and six proof-of-concept readouts expected by end of 2026.
argenx (NASDAQ:ARGX) ha riportato solidi risultati finanziari nel secondo trimestre del 2025, con vendite nette globali di prodotti che hanno raggiunto 949 milioni di dollari, segnando una crescita del 97% rispetto all'anno precedente. L'azienda ha realizzato un utile trimestrale di 245 milioni di dollari, con un utile per azione di 4,02 dollari.
Il lancio di VYVGART SC nella CIDP ha guadagnato slancio con oltre 2.500 pazienti in trattamento a livello globale. L'azienda ha annunciato dati positivi di proof-of-concept per ARGX-119 nella CMS, avanzando verso uno studio registrativo. argenx mantiene il suo obiettivo Vision 2030 di trattare 50.000 pazienti in tutto il mondo, assicurandosi 10 indicazioni etichettate e portando cinque candidati in pipeline alla Fase 3.
Le previsioni per R&S e SG&A dell'azienda rimangono a 2,5 miliardi di dollari, con sei risultati registrativi e sei proof-of-concept attesi entro la fine del 2026.
argenx (NASDAQ:ARGX) report贸 s贸lidos resultados financieros en el segundo trimestre de 2025, con ventas netas globales de productos que alcanzaron los 949 millones de d贸lares, representando un crecimiento interanual del 97%. La compa帽铆a obtuvo un beneficio trimestral de 245 millones de d贸lares, con ganancias por acci贸n de 4,02 d贸lares.
El lanzamiento de VYVGART SC en CIDP ha ganado impulso con m谩s de 2.500 pacientes en tratamiento a nivel mundial. La empresa anunci贸 datos positivos de proof-of-concept para ARGX-119 en CMS, avanzando hacia un estudio registracional. argenx mantiene su objetivo Vision 2030 de tratar a 50.000 pacientes globalmente, asegurando 10 indicaciones etiquetadas y avanzando cinco candidatos en desarrollo a Fase 3.
La gu铆a para I+D y SG&A de la compa帽铆a se mantiene en 2.500 millones de d贸lares, con seis resultados registracionales y seis proof-of-concept esperados para finales de 2026.
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argenx (NASDAQ:ARGX) a annonc茅 de solides r茅sultats financiers pour le deuxi猫me trimestre 2025, avec des ventes nettes mondiales de produits atteignant 949 millions de dollars, soit une croissance de 97 % d'une ann茅e sur l'autre. La soci茅t茅 a r茅alis茅 un b茅n茅fice trimestriel de 245 millions de dollars, avec un b茅n茅fice par action de 4,02 dollars.
Le lancement de VYVGART SC dans la CIDP a pris de l'ampleur avec plus de 2 500 patients en traitement 脿 l'茅chelle mondiale. La soci茅t茅 a annonc茅 des donn茅es positives de preuve de concept pour ARGX-119 dans la CMS, progressant vers une 茅tude d'enregistrement. argenx maintient son objectif Vision 2030 de traiter 50 000 patients dans le monde, d'obtenir 10 indications labellis茅es et de faire avancer cinq candidats en phase 3.
Les pr茅visions de R&D et SG&A de la soci茅t茅 restent 脿 2,5 milliards de dollars, avec six r茅sultats d'enregistrement et six preuves de concept attendus d'ici fin 2026.
argenx (NASDAQ:ARGX) berichtete starke Finanzergebnisse f眉r das zweite Quartal 2025, mit globalen Nettoproduktverk盲ufen von 949 Millionen US-Dollar, was einem Wachstum von 97 % im Jahresvergleich entspricht. Das Unternehmen erzielte einen Quartalsgewinn von 245 Millionen US-Dollar bei einem Gewinn je Aktie von 4,02 US-Dollar.
Der Start von VYVGART SC bei CIDP gewinnt an Fahrt mit 眉ber 2.500 Patienten in Behandlung weltweit. Das Unternehmen gab positive Proof-of-Concept-Daten f眉r ARGX-119 bei CMS bekannt und schreitet zu einer Zulassungsstudie voran. argenx h盲lt an seinem Vision-2030-Ziel fest, 50.000 Patienten weltweit zu behandeln, 10 zugelassene Indikationen zu sichern und f眉nf Pipeline-Kandidaten in Phase 3 zu bringen.
Die Prognose f眉r F&E und SG&A des Unternehmens bleibt bei 2,5 Milliarden US-Dollar, mit sechs Zulassungs- und sechs Proof-of-Concept-Ergebnissen, die bis Ende 2026 erwartet werden.
- Global product net sales reached $949M in Q2 2025, up 97% year-over-year
- Achieved significant quarterly profit of $245M with EPS of $4.02
- Strong cash flow from operations of $362M in H1 2025
- Over 2,500 patients on VYVGART SC treatment globally
- Positive proof-of-concept data for ARGX-119 in CMS
- Pipeline expansion with four new candidates including ARGX-213, ARGX-121, and ARGX-109
- Operating expenses increased significantly to $766M in Q2 2025 vs $535M in Q2 2024
- R&D expenses rose to $328M in Q2 2025 from $225M in Q2 2024
- SG&A expenses increased to $325M from $256M year-over-year
Insights
argenx reports strong Q2 growth with $949M in sales, expanding VYVGART's reach across indications while advancing multiple clinical programs.
argenx has delivered exceptional commercial performance with
The company's VYVGART SC launch in CIDP is gaining significant traction with over 2,500 patients on treatment globally. This represents just the beginning of their addressable market, as they've identified 12,000 patients in the U.S. alone who remain inadequately controlled on standard of care. The recent approval of the VYVGART-SC prefilled syringe in both the U.S. and EU should further accelerate adoption by improving the patient experience.
The financial results reveal robust fundamentals, with
While commercial execution is impressive, argenx's R&D investment reflects their long-term vision, with
Despite increased operating expenses of
VYVGART SC launch in CIDP progresses with more than 2,500 patients on treatment globally
ARGX-119 to advance to registrational study in CMS following positive proof of concept data; three additional topline data readouts across pipeline remain on track for second half of 2025
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
July 31, 2025 7:00 AM CET
Amsterdam, the Netherlands 鈥� argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its half year 2025 results and provided a second quarter business update.
鈥淲e continue to make meaningful progress towards our Vision 2030, advancing bold innovation that has already reached more than 15,000 patients globally鈥� said Tim Van Hauwermeiren, Chief Executive Officer of argenx. 鈥淰YVGART is delivering strong growth across all indications, formulations and regions. We are still in the early stages of capturing the full market opportunity in MG and CIDP, with the recent launch of the VYVGART SC prefilled syringe driving demand from new patients and prescribers. In MG, we are shaping the market as the fastest growing biologic, moving earlier in the patient treatment paradigm, and working toward the broadest possible label. In CIDP, we continue to see consistent patient growth, with ample runway to reach the 12,000 patients in the U.S. who remain inadequately controlled on standard of care. This is just the beginning of the larger growth opportunity ahead. With six registrational and six proof-of-concept readouts expected by the end of 2026, we are executing on our proven innovation playbook that is delivering pipeline-in-a-product opportunities aimed at transforming care for patients with high unmet need.鈥�
Advancing Towards Vision 2030
argenx has established its strategic priorities to advance Vision 2030, aiming to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.
Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe
VYVGART庐 (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) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, China, and the EU. The VYVGART-SC prefilled syringe (PFS) is now approved for use in the U.S. and EU.
- Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of
$949 million in the second quarter of 2025- Strong underlying fundamentals across key patient and prescriber metrics with
97% operational growth in product net sales year-over-year from second quarter 2024, and19% from the first quarter of 2025
- Strong underlying fundamentals across key patient and prescriber metrics with
- First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP
- PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year
- Evidence generation through label-enabling studies:
- Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS)
- Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT)
- Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS)
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches
argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications.
Efgartigimod Development
Efgartigimod is being studied across 15 severe autoimmune diseases, highlighting the broad potential of FcRn biology in neurology, rheumatology, and beyond.
- Registrational studies are currently ongoing in idiopathic inflammatory myopathies (IIM or myositis), thyroid eye disease (TED), and Sj枚gren鈥檚 disease
- Topline results from ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) expected in second half of 2026
- Topline results from two registrational UplighTED studies (TED) expected in second half of 2026
- Topline results from registrational UNITY study (Sj枚gren鈥檚 disease) expected in 2027
- Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027
Empasiprubart Development
Empasiprubart, a first-in-class, humanized, monoclonal antibody that specifically binds to C2, is currently being evaluated in four indications. These include registrational studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM.
- Topline results from registrational EMPASSION study (MMN) evaluating empasiprubart head-to-head versus IVIg expected in second half of 2026
- Registrational EMVIGORATE study ongoing in CIDP evaluating empasiprubart head-to-head versus IVIg
- Topline results expected for DGF in the second half of 2025 and for DM in first half of 2026
ARGX-119 Development
ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).
- Registrational study to start in CMS in 2026 following positive Phase 1b proof-of-concept data
- Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026
- SMA proof-of-concept study on track to start by end of year
- ARGX-119 R&D webinar to be hosted on September 16, 2025
Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program
argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx鈥檚 leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed.
- Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026
- Entered strategic collaboration with Unnatural Products (UNP) to expand argenx discovery capabilities into the oral peptide space. This partnership reinforces argenx's commitment to enhance the patient experience and advance its pipeline of precision therapies.
SECOND QUARTER 2025 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS
| 听 | 听 | Three Months Ended | 听 | Six Months Ended | ||||||||
| 听 | 听 | 30 June, | 听 | 30 June, | ||||||||
| (in thousands of $ except per share data) | 听 | 2025 | 听 | 2024 | 听 | 2025 | 听 | 听 | 2024 | |||
| Product net sales | 听 | $ | 听听听听听听听听948,594听听听听听听听听 | 听 | $ | 听听听听听听听听477,635听听听听听听听听 | 听 | $ | 听听听听听听听听1,738,644听听听听听听听听 | 听 | $ | 听听听听听听听听875,918听听听听听听听听 |
| Other operating income* | 听 | 听 | 听听听听听听听听18,593听听听听听听听听 | 听 | 听 | 听听听听听听听听11,793听听听听听听听听 | 听 | 听 | 听听听听听听听听35,913听听听听听听听听 | 听 | 听 | 听听听听听听听听26,023听听听听听听听听 |
| Total operating income | 听 | $ | 听听听听听听听听967,187听听听听听听听听 | 听 | $ | 听听听听听听听听489,428听听听听听听听听 | 听 | $ | 听听听听听听听听1,774,557听听听听听听听听 | 听 | $ | 听听听听听听听听901,941听听听听听听听听 |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Cost of sales | 听 | $ | 听听听听听听听听(110,747) | 听 | $ | 听听听听听听听听(52,383) | 听 | $ | 听听听听听听听听(191,552) | 听 | $ | 听听听听听听听听(95,561) |
| Research and development expenses | 听 | 听 | 听听听听听听听听(327,697) | 听 | 听 | 听听听听听听听听(225,286) | 听 | 听 | 听听听听听听听听(636,767) | 听 | 听 | 听听听听听听听听(450,255) |
| Selling, general and administrative expenses | 听 | 听 | 听听听听听听听听(324,902) | 听 | 听 | 听听听听听听听听(255,699) | 听 | 听 | 听听听听听听听听(601,150) | 听 | 听 | 听听听听听听听听(491,694) |
| Loss from investment in a joint venture | 听 | 听 | 听听听听听听听听(2,780) | 听 | 听 | 听听听听听听听听(1,521) | 听 | 听 | 听听听听听听听听(5,087) | 听 | 听 | 听听听听听听听听(3,313) |
| Total operating expenses | 听 | $ | 听听听听听听听听(766,126) | 听 | $ | 听听听听听听听听(534,889) | 听 | $ | 听听听听听听听听(1,434,556) | 听 | $ | 听听听听听听听听(1,040,823) |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Operating profit/(loss) | 听 | $ | 听听听听听听听听201,061听听听听听听听听 | 听 | $ | 听听听听听听听听(45,461) | 听 | $ | 听听听听听听听听340,001听听听听听听听听 | 听 | $ | 听听听听听听听听(138,882) |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Financial income | 听 | $ | 听听听听听听听听38,399听听听听听听听听 | 听 | $ | 听听听听听听听听38,933听听听听听听听听 | 听 | $ | 听听听听听听听听75,517听听听听听听听听 | 听 | $ | 听听听听听听听听77,828听听听听听听听听 |
| Financial expense | 听 | 听 | 听听听听听听听听(1,126) | 听 | 听 | 听听听听听听听听(572) | 听 | 听 | 听听听听听听听听(2,261) | 听 | 听 | 听听听听听听听听(1,084) |
| Exchange gains/(losses) | 听 | 听 | 听听听听听听听听48,565听听听听听听听听 | 听 | 听 | 听听听听听听听听(7,903) | 听 | 听 | 听听听听听听听听76,003听听听听听听听听 | 听 | 听 | 听听听听听听听听(27,215) |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Profit/(Loss) for the period before taxes | 听 | $ | 听听听听听听听听286,899听听听听听听听听 | 听 | $ | 听听听听听听听听(15,003) | 听 | $ | 听听听听听听听听489,260听听听听听听听听 | 听 | $ | 听听听听听听听听(89,353) |
| Income tax (expense)/benefit | 听 | $ | 听听听听听听听听(41,541) | 听 | $ | 听听听听听听听听44,069听听听听听听听听 | 听 | $ | 听听听听听听听听(74,433) | 听 | $ | 听听听听听听听听56,822听听听听听听听听 |
| Profit/(Loss) for the period | 听 | $ | 听听听听听听听听245,358听听听听听听听听 | 听 | $ | 听听听听听听听听29,066听听听听听听听听 | 听 | $ | 听听听听听听听听414,827听听听听听听听听 | 听 | $ | 听听听听听听听听(32,531) |
| Profit/(Loss) for the period attributable to: | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 |
| Owners of the parent | 听 | $ | 听听听听听听听听245,358听听听听听听听听 | 听 | $ | 听听听听听听听听29,066听听听听听听听听 | 听 | $ | 听听听听听听听听414,827听听听听听听听听 | 听 | $ | 听听听听听听听听(32,531) |
| Weighted average number of shares used for basic profit/(loss) per share | 听 | 听 | 听听听听听听听听61,084,250听听听听听听听听 | 听 | 听 | 听听听听听听听听59,490,437听听听听听听听听 | 听 | 听 | 听听听听听听听听61,034,202听听听听听听听听 | 听 | 听 | 听听听听听听听听59,400,217听听听听听听听听 |
| Basic profit/(loss) per share (in $) | 听 | 听 | 听听听听听听听听4.02听听听听听听听听 | 听 | 听 | 听听听听听听听听0.49听听听听听听听听 | 听 | 听 | 听听听听听听听听6.80听听听听听听听听 | 听 | 听 | 听听听听听听听听(0.55) |
| Weighted average number of shares used for diluted profit/(loss) per share | 听 | 听 | 听听听听听听听听65,639,446听听听听听听听听 | 听 | 听 | 听听听听听听听听63,893,007听听听听听听听听 | 听 | 听 | 听听听听听听听听65,653,007听听听听听听听听 | 听 | 听 | 听听听听听听听听59,400,217听听听听听听听听 |
| Diluted profit/(loss) per share (in $) | 听 | 听 | 听听听听听听听听3.74听听听听听听听听 | 听 | 听 | 听听听听听听听听0.45听听听听听听听听 | 听 | 听 | 听听听听听听听听6.32听听听听听听听听 | 听 | 听 | 听听听听听听听听(0.55) |
*Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of collaboration revenue and other operating income.
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and six months ended June听30, 2025, was
- Product net sales of VYVGART and VYVGART SC for the three and six months ended June听30, 2025, were
$949 million and$1,739 million , respectively, compared to$478 million and$876 million , respectively, for the same periods in 2024. - Other operating income for the three and six months ended June听30, 2025, was
$19 million and$36 million , respectively, compared to$12 million and$26 million , respectively, for the same periods in 2024. The other operating income for the three and six months ended June听30, 2025 and 2024, primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the three and six months ended June听30, 2025 were
- Cost of sales for the three and six months ended June听30, 2025, was
$111 million and$192 million , respectively, compared to$52 million and$96 million for the same periods in 2024, respectively. The cost of sales was related to the sale of VYVGART and VYVGART SC.听 - Research and development expenses for the three and six months ended June听30, 2025, were
$328 million and$637 million , respectively, compared to$225 million and$450 million , respectively, for the same periods in 2024. The research and development expenses mainly relate to:- the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases;
- the ramp-up of studies for the development of empasiprubart into MMN, DGF, DM and CIDP;
- the investments for ARGX-119 in proof-of-concept studies ongoing in ALS, CMS and SMA; and
- other discovery and preclinical pipeline candidates.
- Selling, general and administrative expenses for the three and six months ended June听30, 2025, were
$325 million and$601 million , respectively, compared to$256 million and$492 million , respectively, for the same periods in 2024. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of VYVGART franchise, and personnel expenses.听听听听听听听听听
Financial income for the three and six months ended June听30, 2025, was
Exchange gains for the three and six months ended June听30, 2025, were
Income tax for the three and six months ended June听30, 2025 and 2024 is detailed below:
| 听 | 听 | Three Months Ended | 听 | Six Months Ended | ||||||||
| 听 | 听 | 30 June, | 听 | 30 June, | ||||||||
| (in millions of $) | 听 | 2025 | 听 | 2024 | 听 | 2025 | 听 | 2024 | ||||
| Current tax (expense)/benefit | 听 | $ | 听听听听听听听听(41) | 听 | $ | 听听听听听听听听(9) | 听 | $ | 听听听听听听听听(70) | 听 | $ | 听听听听听听听听(16) |
| Deferred tax (expense)/benefit | 听 | 听 | 听听听听听听听听(1) | 听 | 听 | 听听听听听听听听53听听听听听听听听 | 听 | 听 | 听听听听听听听听(4) | 听 | 听 | 听听听听听听听听72听听听听听听听听 |
| Income tax (expense)/benefit | 听 | $ | 听听听听听听听听(42) | 听 | $ | 听听听听听听听听44听听听听听听听听 | 听 | $ | 听听听听听听听听(74) | 听 | $ | 听听听听听听听听57听听听听听听听听 |
Profit for the three- and six-month periods ended June听30, 2025, was
Cash flow from operating activities for the six months ended June听30, 2025 was
FINANCIAL GUIDANCE
The financial guidance on the combined research and development and selling, general and administrative remains unchanged at approximately
EXPECTED 2025 FINANCIAL CALENDAR
- October 30, 2025: Third Quarter 2025 Financial Results and Business Update
- February 26, 2025: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update
CONFERENCE CALL DETAILS
The half-year 2025 financial results and second quarter 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 . A replay of the webcast will be available on the argenx website.
Dial-in numbers:
Please dial in 15 minutes prior to the live call.
| Belgium | 32 800 50 201 | 听 | 听 | 听 |
| France | 33 800 943355 | 听 | 听 | 听 |
| Netherlands | 31 20 795 1090 | 听 | 听 | 听 |
| United Kingdom | 44 800 358 0970 | 听 | 听 | 听 |
| United States | 1 888 415 4250 | 听 | 听 | 听 |
| Japan | 81 3 4578 9081 | 听 | 听 | 听 |
| Switzerland | 41 43 210 1132 | 听 | 听 | 听 |
This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
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 and follow us on , , , and .
For further information, please contact:
Media:
Ben Petok
Investors:
Alexandra Roy
Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, 鈥渇orward-looking statements.鈥� These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 鈥渁dvance,鈥� 鈥渁im,鈥� 鈥渃ommitted,鈥� 鈥渃ontinue,鈥� 鈥渆xpand,鈥� 鈥渆xpect,鈥� 鈥済rowth,鈥� and 鈥減rogress鈥� and include statements argenx makes concerning its innovation agenda and growth strategy, including (i) its Vision 2030 to reach 50,000 patients globally across 10 labeled indications and to advance fix pipeline candidates into Phase 3 development by 2030 across efgartigimod, empasiprubart and ARGX-119 to create significant opportunity to expand into new therapeutic areas and reach broader patient populations and (ii) its goal to transform care for patients with high unmet need; its confidence regarding its growth trajectory; its commitment to improving the lives of people suffering from severe autoimmune diseases; its expectation regarding the insights from proof-of-concept and registrational studies across various programs; the advancement of anticipated clinical development, data readouts and regulatory milestones and plans, including: (1) the PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of 2025, (2) topline results for seronegative gMG (ADAPT-SERON) expected in second half of 2025 and for ocular and pediatric MG (ADAPT-OCULUS, JR) expected in first half of 2026, (3) topline results for ADVANCE-NEXT to support FDA submission of VYVGART IV for primary ITP expected in second half of 2026, (4) new therapeutic areas and ongoing registrational studies in three subsets of myositis, thyroid eye disease (TED), and Sj枚gren鈥檚 disease, with topline results from (a) ALKIVIA expected in second half of 2026, (b) two registrational UplightTED studies expected in second half of 2026 and (c) registrational UNITY study expected in 2027, (5) proof-of-studies ongoing in LN, SSc and AMR, with topline results expected in fourth quarter of 2025, second half of 2026 and 2027, respectively, (6) its plans to develop empasiprubart, including (a) registrational EMPASSION study in MMN, with topline results expected in second half of 2026, (b) registrational EMVIGORATE study in CIDP, expected to start in first half of 2025 and (c) topline results for DGM and DM expected in second half of 2025 and first half of 2026, respectively, (7) its plans to develop ARGX-119, including: (a) the registrational study to start in CMS in 2026; (b) Phase 2a proof-of-concept study in ALS, with topline results expected in first half of 2026; and (c) SMA proof-of-concept study; and (8) its plans to advance four new pipeline molecules and generate sustainable value through continue investment in its IIP, through (a) ongoing studies for ARGX-213 and ARGX-121, with results expected in first half of 2026, (b) ARGX-109, with Phase 1 results expected in second half of 2025, and (c) a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx鈥檚 actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx鈥檚 clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx鈥檚 U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx鈥檚 most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
FAQ
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