Reported Earnings • May 07
First quarter 2026 earnings released: EPS: US$5.90 (vs US$2.78 in 1Q 2025) First quarter 2026 results: EPS: US$5.90 (up from US$2.78 in 1Q 2025). Revenue: US$1.31b (up 63% from 1Q 2025). Net income: US$366.0m (up 116% from 1Q 2025). Profit margin: 28% (up from 21% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Announcement • Apr 18
argenx SE Brings Neuromuscular Leadership to AAN 2026 with New Data Supporting Broader VYVGART Use Across MG and CIDP argenx SE announced the presentation of new data for VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago from April 18-22, 2026. Presentations will also highlight new data for adimanebart in congenital myasthenic syndromes (CMS) and argenx’s broader neuromuscular pipeline, including Phase 3 programs evaluating empasiprubart in CIDP. Advancing VYVGART Across Broadest Set of MG Populations: The Phase 3 ADAPT OCULUS study showed that VYVGART is the first and only biologic treatment demonstrating efficacy specifically in patients living with ocular myasthenia gravis (oMG). The study met its primary endpoint (p=0.012), showing oMG patients treated with VYVGART demonstrated statistically significant improvement from baseline in the Myasthenia Impairment Index (MGII) Patient-Reported Outcome (PRO) ocular scores at Week 4 versus placebo. These improvements were supported by the combined patient-reported outcome and physician examination (PRO+PE) assessment (p = 0.018), showing consistent and clinical improvement in key ocular symptoms such as diplopia (double vision) and ptosis (drooping of the upper eyelids). Results will be used to support a planned supplemental Biologics License Application (sBLA) submission to the U.S. Food and Drug Administration (FDA) to expand the label into oMG. The Phase 3 ADAPT SERON trial showed patients treated with VYVGART – across MuSK+, LRP4+, and triple seronegative generalized myasthenia gravis (gMG) – experienced rapid improvements and increasingly pronounced efficacy with each additional cycle as measured by Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores in the open-label extension. These data further support VYVGART’s efficacy and safety across gMG patients regardless of antibody status. A sBLA for this patient population has been granted priority review by the FDA with a target action date of May 10, 2026.Results from ADAPT Jr showed adolescent participants (ages 12-17) demonstrated consistent and repeatable MG-ADL improvements across treatment cycles, with 72.7% in cycle one and 80% in cycle two achieving minimal symptom expression (MSE). Enrollment of a younger pediatric cohort is ongoing. Expanding the Role of VYVGART in CIDP: An ADHERE post hoc analysis supports the potential for earlier, first-line use of VYVGART Hytrulo in CIDP, with 87.5% of treatment-naïve patients treated with VYVGART Hytrulo achieving confirmed early clinical improvement and a median time to response of 39.5 days. These findings address an important evidence gap in patients historically underrepresented in CIDP trials.Real-world physician insights from an assessment of 225 patients showed that 85.7% of the 91 patients who attempted to switch from IVIg to VYVGART Hytrulo were successful, defined by patients demonstrating clinical improvement or maintaining stability without tolerability issues. Switching was driven by clinical and practical considerations, including prior treatment dissatisfaction or lack of efficacy, IVIg-related safety or tolerability concerns, poor venous access, adherence challenges, and patient preference. Progressing Neuromuscular Pipeline: Two Phase 3 CIDP studies highlight argenx’s commitment to advancing innovative treatment options across all adult CIDP patient populations with empasiprubart. Researchers will present trial designs for EMVIGORATE, a head-to-head study versus IVIg, and EMNERGIZE, which evaluates empasiprubart versus placebo.Follow-up results from the Phase 1b study of adimanebart, a MuSK agonist antibody, in DOK7 CMS showed that improvements in key QMG components and six-minute walk test performance (total distance and cadence), observed during the 12-week treatment period, were generally maintained throughout the 30-week treatment-free follow-up period. These results build on previously presented proof-of-concept data and further support adimanebart in this neuromuscular disorder. Announcement • Mar 06
argenx SE Presents New Data and Pipeline Updates At 2026 AAN Annual Meeting argenx SE will present data for VYVGART (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) and pipeline candidates empasiprubart and adimanebart at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago from April 18-22, 2026. Positive results from Phase 3 ADAPT OCULUS study show VYVGART's potential as the first targeted treatment for patients living with ocular MG. Additional data from ADAPT SERON - the largest study of patients with gMG who do not have detectable AChR-Ab - demonstrate VYVGART's efficacy and safety across subtypes. New biomarker analysis, real-world evidence and post-hoc insights highlight VYVGART's expanding treatment approach in CIDP. Notable myasthenia gravis (MG) data supporting pursuit of the broadest label for MG patients to be presented include: Data from the Phase 3 ADAPT OCULUS study, the first registrational study specifically designed to evaluate a targeted therapy for ocular myasthenia gravis (oMG), confirm the therapeutic potential of VYVGART in adults with oMG, marking an important step forward to expand targeted treatment options for these patients. Data from Phase 3 ADAPT SERON and ADAPT Jr studies support the use of VYVGART across broader patient populations, including patients with generalized myasthenia gravis (gMG) who do not have detectable anti-acetylcholine receptor antibodies (AChR-Ab) across three subtypes - MuSK+, LRP4+, and triple seronegative gMG, as well as in adolescents with gMG. Additional MG presentations further characterize the long-term safety and efficacy of VYVGART across both trial and real-world settings, as well as sustained clinical benefit across dosing patterns. In chronic inflammatory demyelinating polyneuropathy (CIDP), argenx will highlight results from an ADHERE post hoc analysis in treatment-na ve patients that underscore VYVGART Hytrulo's impact in this underserved population and support its use earlier in the treatment paradigm. Real-world insights will further illustrate physician approaches to transitioning patients from IVIg to VYVGART Hytrulo to support positive patient outcomes. Featured research also includes ADHERE neurofilament light chain (NfL) data from the most comprehensive dataset to date, advancing CIDP innovation by exploring this potential biomarker of disease. Additional results from the ARGX-119 Phase 1b trial evaluating adimanebart in patients with DOK7 congenital myasthenic syndromes (CMS) will also be shared, providing proof-of-concept support based on a favorable safety profile and consistent functional improvements across multiple efficacy measures. Details for oral and poster presentations at AAN are as follows: Efficacy and Safety of Efgartigimod in Anti-acetylcholine Receptor Antibody-Negative Generalized Myasthenia Gravis: Initial Results of ADAPT SERON. Results from the ADAPT JR Study Investigating Intravenous Efgartigimod in Juvenile Generalized Myasthenia Gravis. Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults With Ocular Myasthenia Gravis: Interim Results of ADAPT OCULUS Part A. Sustained Clinical Efficacy and Long-term Safety of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Part B of ADAPT NXT. Long-term Safety and Efficacy of Subcutaneous Efgartigimod PH20 in Adult Participants With Generalized Myasthenia Gravis: Final Results of the ADAPT-SC+ Study. Design of a Phase 2a Study to Evaluate the Safety, Efficacy, and Tolerability of Intravenous Empasiprubart as an Add-On Therapy to Intravenous Efgartigimod in Adult Participants With Generalized Myasthenia Gravis. Safety and Effectiveness of Efgartigimod in Japanese Patients With Generalized Myasthenia Gravis by Serological Profiles: Analysis of Post-marketing Surveillance. Assessing Efgartigimod Dosing Patterns and Myasthenia Gravis Activities of Daily Living Outcomes in Clinical Practice: Results From a Large Patient Support Program Database in the United States. Impact of Subcutaneous Efgartigimod PH20 on Treatment-na ve Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in the ADHERE Trial: Post Hoc Analyses. Serum NfL Z-score as a Biomarker of Disease Severity and Treatment History in the Largest CIDP Cohort to Date: Insights from the ADHERE Trial. Physician Insights on Transitioning Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy From Intravenous Immunoglobulin to Subcutaneous Efgartigimod PH20. Characteristics of Real-world Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Initiating Subcutaneous Efgartigimod in United States. Beyond Disability: The Burden of Fatigue in CIDP. Real-world Effectiveness and Use of Efgartigimod in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: ADHERE REAL Study Design. Empasiprubart Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMNERGIZE Phase Three Study Design. Empasiprubart vs Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: EMVIGORATE Phase Three Study Design. Phase 1b Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Participants with DOK7 Congenital Myasthenic Syndromes. Efgartigimod is a Unique FcRn Blocker That Allows IgG Reduction Without Broad Inhibition of Immune Responses. VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). Board Change • Mar 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 7 experienced directors. 4 highly experienced directors. Non-Executive Director Brian Kotzin was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Feb 27
Full year 2025 earnings released: EPS: US$21.08 (vs US$13.92 in FY 2024) Full year 2025 results: EPS: US$21.08 (up from US$13.92 in FY 2024). Revenue: US$4.25b (up 89% from FY 2024). Net income: US$1.29b (up 55% from FY 2024). Profit margin: 30% (down from 37% in FY 2024). The decrease in margin was driven by higher expenses. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Announcement • Feb 27
argenx SE, Annual General Meeting, May 06, 2026 argenx SE, Annual General Meeting, May 06, 2026. Announcement • Feb 26
Argenx Se Announces Positive Topline Results from Phase 3 Adapt Oculus Trial of Vyvgart in Ocular Myasthenia Gravis argenx SE announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART®? (efgartigimod alfa and hyaluronidase-qvfc) in adults with ocular myasthenia gravis (oMG). ADAPT OCULUS met its primary endpoint (p-value=0.012), showing that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in patients treated with placebo. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART for oMG to the U.S. FDA by end of third quarter 2026; its commitment to improve the lives of people suffering from severe autoimmune diseases; its plan to present data from the ADAPT OCULUS trial at an upcoming medical meeting; its aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its commercialization of the first approved neonatal Fc receptor (FcRn) blocker and evaluation of its broad potential in multiple serious autoimmune diseases; and its advancement of several earlier stage experimental medicines within its therapeutic franchises. By their nature, forward-looking statements involve risks and uncertainties and readers are caused that any such forward-looking statements are not guarantees of future performance. argenx's 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's 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 inflation and inflation 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's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent recent filings and reports, including in company's most recent ADAPT OCULUS studies, including in the company's most recent ADAPt OCULUS study of VYVGART in Ocular Myasthenia gravis. Announcement • Jan 13
argenx SE Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART in AChR-Ab Seronegative gMG argenx SE announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART®? for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG). The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026. The sBLA is supported by data from the Phase 3 ADAPT SERON study, which evaluated the efficacy and safety of VYVGART in adults with AChR-Ab seronegative gMG across all three subtypes - MuSK+, LRP4+, and triple seronegative gMG. The study met its primary endpoint (p-value=0.0068), demonstrating a statistically significant improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared to placebo after four weeks. These are not all the possible side effects of VYVGART. Announcement • Jan 05
argenx SE Announces the Retirement of Peter Verhaeghe from the Board of Directors argenx SE announced that Peter Verhaeghe is retiring from the Board of Directors after dedicated service to the company since 2008. Announcement • Dec 15
argenx SE Provides Update on UplighTED Studies of Efgartigimod SC in Thyroid Eye Disease argenx SE announced that the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED) will be discontinued. The decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the trials for futility following its review of data from a pre-specified interim analysis. Importantly, efgartigimod showed a favorable safety and tolerability profile, and no new safety signals were identified. The IDMC conducted a futility evaluation of unblinded data from patients completing 24 weeks in the Phase 3 studies. Following close out and database lock, argenx will conduct a comprehensive analysis of the data to enhance understanding of the studies’ outcomes and uncover key biological insights that may inform future research in TED. Data from the studies will be shared at a future medical meeting. The Phase 3 randomized, double-masked, placebo-controlled, multicenter studies are designed to evaluate the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod PH20 SC administered by prefilled syringe in adult participants with thyroid eye disease. Enrolled participants have active, moderate-to-severe thyroid eye disease associated with autoimmune thyroid conditions (Graves' disease or Hashimoto's thyroiditis). Patients were randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period. The primary endpoint is measured as the percentage of participants who were proptosis responders at week 24. Key secondary endpoints include change in proptosis measurement in the study eye from baseline up to week 24, change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline up to week 24, and percentage of participants with resolution of diplopia at week 24. Announcement • Nov 06
argenx SE Announces VYVGART SC Prefilled Syringe for Self-Injection in Chronic Inflammatory Demyelinating Polyneuropathy Authorized for Sale by Health Canada argenx SE announced that Health Canada has issued a Notice of Compliance authorizing VYVGART SC (efgartigimod alfa injection) as a monotherapy for the treatment of adult patients with active chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART SC is authorized for CIDP as a once weekly 20-30 second subcutaneous injection in a prefilled syringe, offering patients the flexibility to self-administer or receive treatment from a caregiver or healthcare professional--at home, while 'on the go,' or in a clinical setting. With this milestone, VYVGART SC becomes the first innovative treatment for CIDP in more than 30 years, and the first-and-only neonatal Fc receptor (FcRn) blocker authorized in Canada for CIDP. CIDP is a rare, debilitating and often progressive autoimmune disorder of the peripheral nervous system. People living with CIDP experience a range of disabling mobility and sensory issues, such as difficulty standing from a seated position, pain, fatigue, and frequent tripping or falling. As the disease progresses, patients may require the use of a wheelchair and may be unable to work or participate in daily activities. Globally, 85% of patients require ongoing treatment and nearly 88% of treated patients continue to experience residual impairment and disability. Currently available CIDP treatments include intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) with CIDP patients accounting for approximately 20% of IVIg/SCIg use in Canada1. Demand for human-derived blood products continues to grow at 7-8% annually in Canada2, underscoring the importance of new, targeted treatment alternatives such as VYVGART SC to help reduce demand and support future supply of blood products. The Health Canada authorization is supported by positive results from the ADHERE study, the largest clinical trial conducted to date in CIDP. In this study, 69% (221/322) of patients treated with VYVGART SC, regardless of prior treatment, demonstrated evidence of clinical improvement, including enhanced mobility, function, and strength. The study met its primary endpoint (p about ADHERE: The ADHERE trial was a multi-center, randomized, double-blind, placebo-controlled trial evaluating efgartigimod alfa SC for the treatment of CIDP. ADHERE enrolled 322 adult patients with CIDP. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and, in order to be eligible for Stage A, had to demonstrate active disease with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment-naive patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) with efgartigimod Alfa SC.ECI was achieved through improvement of the INCAT score, or improvement on I-RODS or mean grip strength if those scales had demonstrated worsening during CIDP. Reported Earnings • Nov 02
Third quarter 2025 earnings released: EPS: US$5.61 (vs US$1.52 in 3Q 2024) Third quarter 2025 results: EPS: US$5.61 (up from US$1.52 in 3Q 2024). Revenue: US$1.15b (up 96% from 3Q 2024). Net income: US$344.3m (up 277% from 3Q 2024). Profit margin: 30% (up from 16% in 3Q 2024). The increase in margin was driven by higher revenue. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in Europe. Announcement • Oct 29
argenx SE Presents New Data At AANEM and MGFA Highlighting the Strength and Broad Benefit of VYVGART for Myasthenia Gravis Patients argenx SE announced the presentation of new data further highlighting the efficacy and safety of VYVGART® (IV: efgartigimod alfa-FCab and SC or Hytrulo: efgartigimOD alfa and hyaluronidase-qvFC) across generalized myasthenia gravis (gMG) patient populations at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM) and Myastheniaravis Foundation of America (MGFA) Scientific Session in San Francisco from October 29 - November 1, 2025. The data presented feature pivotal Phase 3 results from the ADAPT SERON trial in acetylcholine receptor antibody (AChR-Ab) seronegative patients, interim findings from the ADAPT Jr study in adolescents, a real-world claims analysis showing significantly reduced steroid use among patients treated with VYVGART, long-term outcomes from VYVGART SC treatment with the majority of patients achieving minimal symptom expression (MSE), and a range of other important results. Collectively, these data provide strong evidence of VYVGART's potential to improve outcomes across the full spectrum of gMG patient populations. No new safety concerns were identified. Results from the ongoing ADAPT SERON study indicate that pathogenic IgGs are an underlying driver of gMG across patient subtypes, regardless of autoantibody status. argenx plans to share these results with the U.S. FDA and seek expansion of the VYVGART label to include adult AChR-Ab seronegative gMG patients across all three subtypes. The ADAPT SERON trial showed that efgartigimod generated tangible improvements in daily functioning, marking an important advancement for the field and for seronegative patients seeking better disease control. At 18 months, the average daily GC dose for patients receiving VYVGART decreased by more than 50% (from 16.6 to 7.5 mg/day), with most patients (55%) receiving an average daily GC dose of 5 mg/day or less, and 30% of patients receiving no GC. Improvements in MG-ADL scores of ~5 points were observed among patients with available data, supporting the clinical benefit of steroid tapering alongside maintained disease control. Demonstrating Sustained MSE and F favorable Safety Profile in Long-Term Treatment. Final results from the ADAPT-SC+ open-label extension study demonstrated that VYVGART SC was well-tolerated during 459.4 participant-years of follow-up and up to 33 treatment cycles. No new safety signals were identified with long-term use. Announcement • Oct 15
argenx SE to Highlight Key Data and Breadth of Immunology Innovation at 2025 AANEM Annual Meeting and MGFA Scientific Session argenx SE will present data for VYVGART®? (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimOD alfa and hyaluronidase-qvFC) and pipeline candidate efgartimod at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco from October 29- November 1, 2025. Details for oral and poster presentations at AANEM and MGFA are as follows: Generalized Myasthenia Gravis (gMG) Phase 3 Trial Investigating Impact of Intravenous Efgartigimod in Anti-Acetylcholine MGFA Receptor Antibody Negative Generalized MyastheniaGravis Oral Presentation #101 Session B: Therapeutics and Clinical Trials. Results from the ADAPT Jr Study Investigating Intravenous EfgART in Juvenile MGFA. Session B: Therapeutics, Clinical Trials. Session B: Therape therapeutics and Clinical Trials. Session B:Therapeutics and Clinical Trials. Session C: Patient Care, Hot Topics, Retrospective/Post-hoc Studies at AANEM and MG FA. Recent Insider Transactions • Sep 10
Co-Founder recently sold €6.1m worth of stock On the 3rd of September, Timothy Van Hauwermeiren sold around 10k shares on-market at roughly €609 per share. This transaction amounted to 63% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Timothy has been a net seller over the last 12 months, reducing personal holdings by €6.2m. 
