Randomized, Double-Blind, Pharmacokinetic (PK) and Glucodynamic (GD) Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) of Rapid Acting Insulin Analogs With and Without Recombinant Human Hyaluronidase (rHuPH20)

The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).
This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2. Stage 2 was not initiated due to a strategic business decision and termination was not based on safety or efficacy concerns. No participants were enrolled in Stage 2.

Start Date01 Jan 2011

Sponsor / Collaborator

Halozyme Therapeutics, Inc.

NCT01194245

/ CompletedPhase 2

A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

Start Date01 Aug 2010

Sponsor / Collaborator

Halozyme Therapeutics, Inc.

NCT00979875

/ CompletedPhase 1

Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic, 6-Way Crossover Study of Subcutaneously Administered Insulin Analogs With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Analogs Alone in Healthy Volunteers

This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

Start Date01 Sep 2009

Sponsor / Collaborator

Halozyme Therapeutics, Inc.

100 Clinical Results associated with Insulins(Halozyme)

100 Translational Medicine associated with Insulins(Halozyme)

100 Patents (Medical) associated with Insulins(Halozyme)

969

Literatures (Medical) associated with Insulins(Halozyme)

01 Feb 2026·Diabetes Technology & Therapeutics

Use of Inhaled Insulin with Automated Insulin Delivery Systems

Review

Author: Beck, Roy W. ; Cengiz, Eda

Innovations in diabetes medications and technologies have revolutionized our approach to the management of diabetes. Automated insulin delivery (AID) systems have substantially improved overall glycemia and time-in-range; however, AID systems do not eliminate postprandial hyperglycemia or correct hyperglycemia quickly, given the glucose-lowering action lag of insulins that are used in AID systems. Inhaled insulin offers a novel approach to prandial insulin delivery, characterized by rapid absorption kinetics and a “rapid on, rapid off” pharmacokinetic profile that closely mimics endogenous insulin secretion and can compensate for the glucose-lowering action delay of subcutaneous insulin delivery. While the integration of inhaled insulin with AID systems presents an opportunity to address the limitations of subcutaneous insulin formulations, challenges remain in harmonizing the pharmacokinetics of inhaled insulin with AID systems. This article reviews the current evidence supporting the potential role of concomitant use of TI with AID and gaps in our current knowledge that need to be filled with future studies.

01 Feb 2026·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

Diabetes in pregnancy and major new advances in diabetes care using long-acting and ultralong-acting insulins

Review

Author: Seif, Karl E ; Higgs, Arielle J ; Reece, E Albert ; Drummond, Rosa F

Pregestational diabetes complicates 1% to 2% of all pregnancies. Achievement of euglycemia prevents adverse maternal, fetal, and neonatal outcomes. Insulin is the first line and the backbone of diabetes treatment in and out of pregnancy, but the delicate balance between stringent control and hypoglycemia, along with the complexity and interruption of multiple injections per day, continues to make glycemic control challenging. The ideal basal insulin has a flat pharmacodynamic profile with minimal variability and is relatively easy for patients and clinicians to use. Insulin analogs, such as insulins glargine and detemir, are the most common basal insulins used in pregnancy at this time, but insulin degludec, which has advantages like prolonged duration of action in the nonpregnant population, was recently shown to be equally as effective as detemir in pregnancy. The ease of a once-daily injection without an increased risk of hypoglycemia is attractive to patients and clinicians who wish to simplify insulin regimens. Furthermore, there are current clinical trials evaluating once-weekly basal insulin regimens in the general population. This would decrease basal injections from a minimum of 365 per year to 52 per year, potentially increasing adherence and improving glycemic control. This review will discuss the evidence for insulin degludec in pregnancy as well as discuss the potential benefits and drawbacks of once-weekly ultralong-acting basal insulins in pregnancy.

01 Feb 2026·Primary Care Diabetes

Type 2 diabetes monitoring and control in migrants and non-migrants: A population-based cohort study in primary care in the Netherlands

Article

Author: van Hout, H P J ; van Valkengoed, I G M ; Maarsingh, O R ; Remmelzwaal, S ; Overbeek, J A ; Herings, R M C ; Blom, M T ; Strooij, B T ; Muilwijk, M ; Elders, P J M

AIMS:

Type 2 diabetes (T2D) disproportionally affects migrants. We compared T2D-care in primary care between migrants and non-migrants in the Netherlands.

METHODS:

We performed a dynamic cohort study based on routine care data (2015-2019) from the DIAbetes MANagement and Treatment (DIAMANT) cohort linked to databases of Statistics Netherlands. Persons aged ≥ 35years with T2D treated in primary care were included. Outcomes included annual monitoring of HbA1c, systolic blood pressure and LDL; meeting of treatment targets; and medication prescription. Generalized estimating equations logistic regression models estimated the associations between having a migration background and outcomes.

RESULTS:

We included 165,670 persons: 83.7 % non-migrants, 2.1 % Turkish, 3.0 % Moroccan, 2.1 % Surinamese, 3.3 % European, and 5.7 % other non-European migrants. Most migrant groups had similar or higher odds of having annual monitoring compared to non-migrants, but lower odds of meeting the HbA1c and LDL treatment targets, with the lowest odds for Turkish migrants (OR 0.61, 95 %-CI 0.57-0.64; OR 0.86, 95 %-CI 0.81-0.91). Exploratory analyses demonstrated insulins to be less often prescribed to migrants.

CONCLUSIONS:

Most migrant groups were equally or better monitored for T2D-parameters compared to non-migrants, but were less likely to meet HbA1c targets. This might partly reflect the less frequent insulin prescriptions to migrants. Further research is needed on underlying mechanisms and the specific needs of migrant groups to optimize T2D-care for all.

News (Medical) associated with Insulins(Halozyme)

26 Jan 2026

·www.globenewswire.com

MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy

Updated initial conversion table based on clinical trials in adults showing significantly improved mealtime glycemic excursions DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Prescribing Information for Afrezza® (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. “We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind Corporation. “We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza’s established clinical profile.” The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study (see graph) and the INHALE-3 trial that demonstrated improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose. The revised dosing recommendations, provided in the table below, include recommended dose conversions from injected mealtime insulin or insulin pump bolus dosing to the appropriate mealtime dosage of Afrezza and are intended to support a clinically appropriate and safe transition for adult patients initiating Afrezza. Please see the Full Prescribing Information for additional details. Table 1: Recommended Starting Mealtime Dosage of Afrezza when Switching from Other Mealtime Insulin Regimens Current Subcutaneous Mealtime Insulin DosageStarting Dosage of AFREZZAUp to 3 units4 units4 to 5 units8 units6 to 7 units12 units8 or more units16 units About AfrezzaAfrezza® (pronounced uh-frezz-uh) Inhalation Powder is the only ultra rapid-acting inhaled insulin approved by the U.S. Food and Drug Administration to improve glycemic control in adult patients with diabetes mellitus. Administered at the beginning of meals using a small, portable inhaler, Afrezza delivers insulin via MannKind’s proprietary Technosphere® technology, enabling ultra-rapid absorption through the lungs. Afrezza has a fast onset of action and a short duration, more closely mirroring the body’s natural insulin response to meals. INDICATION AND IMPORTANT SAFETY INFORMATION WITH WARNINGS Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking. WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPDBefore initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. Afrezza is contraindicated: during episodes of hypoglycemia, in patients with chronic lung disease (such as asthma or COPD) because of the risk of acute bronchospasm, and in patients with previous severe hypersensitivity reaction to regular human insulin product or any of the inactive ingredients in Afrezza. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Afrezza. In a study of patients with asthma whose bronchodilators were temporarily withheld for assessment, bronchoconstriction and wheezing following Afrezza dosing was reported. Before initiating therapy, evaluate all patients with a medical history, physical examination, and spirometry (FEV1) to identify potential underlying lung disease. Do not use in patients with chronic lung disease such as asthma or COPD. Changes in an insulin regimen (e.g., insulin strength, manufacturer, injection site or type, or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. If clinically indicated, make any necessary changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. For patients with type 2 diabetes, dosage modifications of concomitant oral antidiabetic treatment may be needed. Hypoglycemia is the most common adverse reaction associated with insulins, including Afrezza. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly, and symptoms may differ across patients and change over time in the same patient. Advise patients to recognize and manage hypoglycemia and self-monitor glucose. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of glucose monitoring is recommended. Afrezza causes a decline in lung pulmonary function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza-treated patients experienced a small (40 mL) but greater FEV1 decline than comparator-treated patients. Assess pulmonary function with spirometry at baseline, after the first 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. In patients who have a decline of ≥20% in FEV1 from baseline, consider discontinuing Afrezza. Consider more frequent lung function assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue Afrezza. In clinical trials, 2 cases of lung cancer were observed in patients exposed to Afrezza while no cases were reported for the comparators. In both cases, a prior history of heavy tobacco use was identified as a risk factor for lung cancer. Two additional cases of lung cancer (squamous cell and lung blastoma) were reported in non-smokers exposed to Afrezza after the trial completion. These data are insufficient to determine whether Afrezza has an effect on lung or respiratory tract tumors. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of Afrezza use outweigh this potential risk. In clinical trials enrolling patients with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in Afrezza-treated patients (0.43%; n=13) than in comparator-treated patients (0.14%; n=3). Patients with type 1 diabetes should always use Afrezza concomitantly with basal insulin. In patients at risk for DKA, such as those with an acute illness or infection, increase the frequency of glucose monitoring and consider discontinuing Afrezza and giving insulin using an alternate route of administration. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products. If hypersensitivity reactions occur, discontinue Afrezza, treat per standard of care and monitor until symptoms and signs resolve. All insulin products, including Afrezza, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated. Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Observe these patients for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the TZD should be considered. Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation. Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety. About MannKindMannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. Forward-Looking StatementsStatements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding clearer guidance regarding the initiation of insulin therapy. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing and commercializing product candidates and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its most recently filed Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. AFREZZA, MANNKIND and TECHNOSPHERE are registered trademarks of MannKind Corporation. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9c8efef3-3fac-4191-b791-45429abb7399 MannKind Contacts: Media Relations: Christie Iacangelo (818) 292-3500 media@mnkd.com Investor Relations: Kate Miranda (781) 301-6869 ir@mnkd.com

Clinical ResultDrug ApprovalClinical Study

12 Jan 2026

·www.globenewswire.com

argenx Highlights 2026 Strategic Priorities

Reported $4.15 billion (YoY growth of +90%) in preliminary* full-year 2025 global product net sales, inclusive of $1.29 billion in fourth quarter sales VYVGART impact continues with approximately 19,000 patients on treatment; and if approved, AChR-Ab seronegative gMG launch expected by end of 2026 Four registrational readouts expected in 2026, including first for empasiprubart, to advance toward next wave of 2027 commercial launches Successfully advanced four new pipeline molecules in 2025; three new molecules to enter Phase 1 in 2026, contributing to total of 10 clinical-stage molecules by year-end January 12, 2026, 7:00 a.m. CETAmsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today reported preliminary financial results for the full-year 2025, including global product net sales, and announced its strategic priorities for 2026. “argenx enters 2026 in a position of strength, delivering meaningful impact to approximately 19,000 patients globally while advancing a world-class pipeline toward Vision 2030,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “With VYVGART leading the growth of all biologics in MG and CIDP, we are proving the power of our approach: to redefine treatment paradigms through disciplined evidence generation and to redefine patient outcomes with medicines that are both more effective and more convenient. This same playbook will guide our future, as we aim to launch a portfolio of new medicines that could transform the lives of more than 50,000 patients across 10 indications.” “Looking at the year ahead, we will expand our FcRn franchise and report the first Phase 3 data for our next potential blockbuster medicine, with four registrational readouts across both efgartigimod and empasiprubart. In addition, we will continue to grow intentionally, by sourcing innovation where the best science emerges, nurturing an entrepreneurial culture, and scaling with discipline to deliver long-term, durable value for patients and shareholders,” added Mr. Van Hauwermeiren. 2026 Strategic Priorities argenx continues to advance its ‘Vision 2030’, anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications across approved medicines, and progress five pipeline candidates into Phase 3 development by 2030. 2026 marks a defining year on the path to Vision 2030 with three strategic priorities: Impact more patients globally with VYVGART, driving broader adoption across current patient populations and unlocking new opportunities with potential label expansionsShape the long-term future of FcRn medicines, advancing future FcRn molecules, innovative delivery modalities and combination approaches designed to transform patient outcomesDeliver next wave of immunology innovation, accelerating empasiprubart and diversified pipeline of first-in-class molecules to drive sustainable value creation Impact more patients globally with VYVGART 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 aims to drive broad adoption across patients globally, reinforcing VYVGART’s position as the leading precision biologic in MG and CIDP and continuing to raise the bar for patient outcomes. The company is progressing toward multiple label expansions. This includes seeking the broadest label of any biologic in MG with the seronegative MG launch, if approved, and an ocular MG Phase 3 readout, and in ITP with the Phase 3 readout to support a U.S. launch. Submitted supplemental Biologics License Application (sBLA) for VYVGART IV for anti-acetylcholine receptor antibody negative gMG (MuSK+, LRP4+ and triple seronegative); if approved, launch expected by end of 2026Topline results expected for ocular MG (ADAPT OCULUS) in first quarter of 2026Topline results expected for primary ITP (ADVANCE-NEXT) in fourth quarter of 2026Registrational studies are ongoing in two rheumatology indications Topline results from ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) expected in third quarter of 2026Topline results from UNITY study (Sjogren’s disease) expected in second half of 2027 Registrational study in Graves’ disease (GD) expected to initiate in 2026, expanding development into thyroid-driven autoimmunityProof-of-concept studies ongoing in systemic sclerosis, antibody mediated rejection and autoimmune encephalitisExpanded global presence in Latin America with establishment of argenx Brazil in 2025 Shape the long-term future of FcRn medicines argenx is shaping the long-term future of FcRn medicines by advancing new pipeline candidates, innovative delivery modalities, and combination approaches to set new standards for patients. Two future FcRn molecules are progressing: ARGX-213, an FcRn-targeted antibody engineered for half-life extension and sustained IgG reduction, and ARGX-124, a first-in-class FcRn pipeline candidate. The ADAPT-Forward study is now underway, which is the first in a series of trials exploring efgartigimod-anchored combinations to potentially improve patient outcomes. VYVGART SC autoinjector expected to launch in 2027, reinforcing a commitment to continued flexibility and independence for patientsADAPT-Forward combination study ongoing to evaluate empasiprubart as an add‑on therapy to efgartigimod, exploring potential for even deeper efficacy in AChR‑positive gMG patientsARGX-213 is expected to enter patient studies in 2026ARGX-124 is expected to complete Phase 1 evaluation by end of 2026Innovation in FcRn continues through partnerships with Elektrofi (now part of Halozyme) and Unnatural Products to further enhance the patient experience Deliver next wave of immunology innovation By the end of 2026, the argenx pipeline will include four Phase 3 molecules and a total of 10 molecules in clinical development. Empasiprubart, a first-in-class antibody targeting C2, is in Phase 3 for MMN and CIDP, and adimanebart (ARGX-119), a first-in-class agonist antibody targeting muscle-specific kinase (MuSK), will enter Phase 3 for congenital myasthenic syndromes (CMS). Additional proof-of-concept studies are underway to further explore C2 and MuSK biology. In 2025, four new candidates emerged from the Immunology Innovation Program (IIP), argenx’s engine for sourcing novel biology and accelerating differentiated medicines. These include FcRn candidates ARGX-213 and ARGX-124, and ARGX-109 (targeting IL-6) and ARGX-121 (a first-in-class molecule targeting IgA). Three additional molecules from the IIP are expected to enter Phase 1 in 2026, supporting argenx’s goal of launching, on average, one new pipeline candidate each year. Empasiprubart Topline results from EMPASSION study (MMN) expected in fourth quarter of 2026Topline results from EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027Decision for Phase 2 VARVARA study (DGF) now expected mid-year 2026 to complete 52-week efficacy analysis Adimanebart CMS registrational study on track to start in third quarter of 2026Proof-of-concept studies ongoing in amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA) Earlier-stage Programs Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026Entered into a research collaboration with Tensegrity Pharma, including an option for future acquisition, to advance Tensegrity’s lead program TSP-101 in autoimmune disease and other indications.Three new molecules expected to enter Phase 1 studies in 2026, including ARGX-118, a first-in-class molecule targeting Galectin-10, ARGX-125, a first-in-class bispecific antibody, and TSP-101, targeting Fn14 Corporate Highlights argenx recently announced that Karen Massey, current Chief Operating Officer, will transition to Chief Executive Officer and Executive Director, and Tim Van Hauwermeiren, current Chief Executive Officer, will transition to non-Executive Director and Chairman of the Board of Directors. Tim will succeed Peter Verhaeghe, who is retiring from the Board of Directors. These changes are subject to shareholder approval at the Annual General Meeting on May 6, 2026. In addition, Sandrine Piret-Gérard has been appointed Chief Commercialization Officer. Sandrine brings extensive commercial and medical affairs experience, most recently leading the U.S. commercial organization at Gilead across virology and oncology. Preliminary* Key Fourth Quarter and Full-Year 2025 Financial Results Today, argenx also announced preliminary* global product net sales for the fourth quarter and full-year 2025 of approximately $1.29 billion and $4.15 billion, respectively. *The preliminary selected financial information is unaudited, subject to adjustment, and provided as an approximation in advance of the company’s announcement of complete financial results in February 2026. Refer to the Preliminary Financial Results note in this document. 44th Annual J.P. Morgan Healthcare Conference Presentation and Webcast CEO Tim Van Hauwermeiren will highlight these updates in a corporate presentation at the 44th Annual J.P. Morgan Healthcare Conference today, Monday, January 12, 2026, at 8:15 a.m. PT. The live webcast of the presentation may be accessed under the Investor section on the argenx website. A replay will be available for 30 days following the presentation. About VYVGART and VYVGART SC 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 Japan. VYVGART SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. It is marketed as VYVGART® Hytrulo in the U.S., VYVGART SC in Europe, VYVDURA® in Japan, and may be marketed under different proprietary names following approval in other regions. 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). Media:Ben Petokbpetok@argenx.com Investors:Alexandra Royaroy@argenx.com Preliminary Financial Results The financial information presented in this press release is preliminary, estimated, and unaudited. They are subject to the completion and finalization of argenx’s financial and accounting closing procedures. They reflect management’s estimates based solely upon information available to management as of the date of this press release. Further information learned during that completion and finalization may alter the final results. In addition, the preliminary estimates should not be viewed as a substitute for full quarterly and annual financial statements prepared in accordance with IFRS. There is a possibility that argenx’s financial results for the quarter ended December 31, 2025, and full year financial results for 2025 could vary materially from these preliminary estimates. In addition to the completion of the financial closing procedures, factors that could cause actual results to differ from those described above are set forth below. Accordingly, you should not place undue reliance upon this preliminary information. Additional information regarding the company’s fourth quarter 2025 financial results and full year financial results for 2025 will be available in the company’s annual report and Form 20-F, which will be filed with the Netherlands Authority for the Financial Markets and U.S. Securities and Exchange Commission (the “SEC”), respectively. Forward Looking StatementsThe 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,” “deepen,” “develop,” “expect,” “grow,” “potential,” “progress,” and “will,” and include statements argenx makes concerning its continued impact of VYVGART and if approved, the potential launch of AChR-Ab seronegative gMG launch by end of 2026; its four registrational readouts expected in 2026 to advance efgartigimod and empasiprubart towards next wave of 2027 commercial launches; the advancement of its pipeline, with three new molecules to enter Phase 1 in 2026, contributing to total of 10 clinical-stage molecules by year-end; its advancement of a world-class pipeline toward Vision 2030; its continued advancement of Vision 2030, anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications across approved medicines, and progress five pipeline candidates into Phase 3 development by 2030; its intentional growth by sourcing innovation where the best science emerges, preserving its entrepreneurial culture, and scaling with discipline to deliver long-term, durable value for patients and shareholders; its belief that 2026 will be a defining year that will deepen its immunology leadership and broaden patient impact, including its goal to impact more patients globally with VYVGART by driving broader adoption across current patient populations while unlocking new opportunities through potential label expansions; the timing of a potential (1) launch in AChR- seronegative MG, and (2) Phase 3 readouts in ocular MG and ITP; the advancement of anticipated clinical development, data readouts and regulator milestones and plans, including: (1) the potential approval and launch by the end of 2026 of an sBLA for VYVGART IV for anti-acetylcholine receptor antibody negative gMG (MuSK+, LRP4+ and triple seronegative; (2) topline results for ocular MG (ADAPT OCULUS) in first quarter of 2026; (3) topline results for primary ITP (ADVANCE-NEXT) in fourth quarter of 2026 to support label expansion outside Japan; (4) ongoing registrational studies in two rheumatology indications, in Graves’ disease, and in multiple proof-of-concept indications, including: (a) potential topline results from ALKIVIA study evaluating autoimmune inflammatory myopathies (AIM or myositis) in third quarter of 2026; (b) potential topline results from UNITY study (Sjögren’s disease) in second half of 2027; (c) potential initiation of a registrational study in Graves’ disease (GD) in first half of 2026, expanding development into thyroid-driven autoimmunity; (5) broadened global presence in Latin America through establishment of argenx Brazil in 2025; the progression of ARGX-213 and ARGX-124; the progression of a series of trials exploring efgartigimod-anchored combinations to potentially improve patient outcomes, including: (1) the potential launch of VYVGART SC autoinjector in 2027; (2) the ongoing ADAPT-Forward combination study; (3) potential studies for ARGX-213 in 2026; (4) potential completion of ARGX-124’s Phase 1 evaluation by end of 2026; and (5) continued innovation in FcRn through partnerships with Elektrofi (now part of Halozyme) and Unnatural Products; its goal to have five Phase 3 molecules and a total of 10 molecules in clinical development by the end of 2026; the additional proof-of-concept studies underway to further explore the potential of C2 and MuSK biology, with: (1) potential topline results from EMPASSION study (MMN) for empasiprubart in fourth quarter of 2026; (2) potential topline results for empasiprubart from EMVIGORATE and EMNERGIZE studies (CIDP) in second half of 2027; (3) potential for decision for Phase 2 VARVARA study (DGF) for empasiprubart now mid-year 2026 to complete 52-week efficacy analysis; (4) potential for CMS registrational study for adimanebart to start in third quarter of 2026; and (5) proof-of-concept studies for adimanebart ongoing in amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA); its goal to launch at least one new pipeline candidate each year on a go-forward basis, with: (1) IgA nephropathy (IgAN) nominated as first Phase 2 indication to be explored with ARGX-121; (2) its research collaboration with Tensegrity Pharma; (3) the entry of three new molecules into its pipeline in 2026, including ARGX-118, ARGX-125, and TSP-101; its aim to shape the long-term future of FcRn medicines, and deliver the next wave of immunology innovation; its commitment to improve the lives of people suffering from severe autoimmune diseases; its belief that its priorities for VYVGART will reinforce its position as the leading precision biologic and continue to raise the bar on patient outcomes; 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; its anticipated leadership changes; its future financial and operating performance, including its anticipated global product net sales for Q4 2025 and FY 2025; 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 cautioned 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 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’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s 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.

Phase 2Drug ApprovalExecutive ChangePhase 3Phase 1

15 Dec 2025

·www.globenewswire.com

argenx Provides Update on UplighTED Studies of Efgartigimod SC in Thyroid Eye Disease

15 December, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today 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. “We are disappointed the studies did not meet our desired outcome and we especially empathize with patients who are living with TED and seeking new therapies for this challenging disease,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “We had pre-planned this futility analysis as it provides a meaningful interim evaluation of observed patient outcomes and enables us to responsibly evaluate the study’s future likelihood of success. This approach is fundamental to our disciplined and responsible stewardship of investment and resources in our clinical development programs. We are deeply grateful to the TED community and all those who contributed to these studies.” 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. UplighTED Study DesignThe 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. About Thyroid Eye Disease (TED)Thyroid Eye Disease (TED) is an autoimmune orbital disease associated with Graves’ disease and other autoimmune thyroid pathologies such as Hashimoto’s thyroiditis. TED is characterized by extraocular muscle enlargement, orbital adipose tissue expansion, and orbital inflammation, which can lead to proptosis, diplopia, or vision loss in severe cases. Persistent orbital symptoms often impair patient quality of life. In the active phase, swelling and protrusion can cause pain and may affect vision. In the inactive phase, some symptoms may improve; however, protrusion and double vision may persist. About VYVGART and VYVGART SC 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 Japan. VYVGART SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. It is marketed as VYVGART® Hytrulo in the U.S., VYVGART SC in Europe, VYVDURA® in Japan, and may be marketed under different proprietary names following approval in other regions. 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 www.argenx.com and follow us on LinkedIn, Instagram, Facebook, and YouTube.    Media:   Colin McBean  cmcbean@argenx.com  Investors:   Alexandra Roy   aroy@argenx.com   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 “aim,” “committed,” “may,” “plan,” and “will” and include statements argenx makes concerning its future analysis of the data from the Phase 3 UplighTED studies to enhance understanding of the studies’ outcomes and uncover key biological insights that may inform future research in TED; the sharing of the data from the Phase 3 UplighTED studies at a future medical meeting; its commitment to improving the lives of people suffering from severe autoimmune diseases; 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’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 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’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s 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.

Phase 3Clinical ResultDrug ApprovalImmunotherapy

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 2	United States	Halozyme Therapeutics, Inc.	01 Aug 2010
Diabetes Mellitus, Type 2	Phase 2	United States	Halozyme Therapeutics, Inc.	01 Jul 2009

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00883558 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	48	recombinant human insulin (INSULIN-PH20 NP)	fodwogsqis(xjfcszessg) = fithdhukik yfgxccawyr (qgtnwiarzc, 36.040) View more	-	08 Sep 2014
				Insulin Lispro (Insulin Lispro)	fodwogsqis(xjfcszessg) = hehzsgdwhk yfgxccawyr (qgtnwiarzc, 35.113) View more
NCT00774800 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	22	rHuPH20+Humalog (Humalog + rHuPH20)	ewvezvsqez(rgbxivjggt) = hzsnuetper gotrfnknbu (qfmtaajecu, 4996.79) View more	-	05 Sep 2014
				Humalog (Humalog Alone)	ewvezvsqez(rgbxivjggt) = cprilukwca gotrfnknbu (qfmtaajecu, 3670.03) View more
NCT01194245 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	135	recombinant human hyaluronidase PH20+insulin aspart+insulin lispro (Analog-PH20)	wdqmyixopq(ehlivrupga) = gmxlgxnprb dexajhttrg (hkbmbdbaxa, 0.415) View more	-	19 Aug 2014
				Insulin Lispro (Insulin Lispro)	wdqmyixopq(ehlivrupga) = ewjpfleonq dexajhttrg (hkbmbdbaxa, 0.440) View more
NCT00916357 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	23	Humalog (Humalog Alone)	fljmqtxneh(wvqnrbxfjd) = bfjehbfwbl tolzjhleld (joanlebglp, 32.28) View more	-	18 Aug 2014
				rHuPH20+Humalog (Humalog + rHuPH20)	fljmqtxneh(wvqnrbxfjd) = fywflfeeyl tolzjhleld (joanlebglp, 28.08) View more
NCT01275131 (CTgov)	Phase 1	Diabetes Mellitus, Type 1	45	Insulin Aspart (Stage 1: Insulin Aspart Alone)	rblhksufmo(spqvstcmls) = jzvafhkyvh yjhmpxysnu (rxjbklsgwg, 6.37) View more	-	25 Jul 2014
				Insulin Aspart-rHuPH20 (Stage 1: Insulin Aspart-rHuPH20)	rblhksufmo(spqvstcmls) = pjapjjrwmo yjhmpxysnu (rxjbklsgwg, 9.48) View more
NCT00705536 (CTgov)	Phase 1	Diabetes Mellitus	26	Humalog (Stage 1: Humalog Alone)	sxxhqwjpjp(nevuvcuilz) = invdipeiut dphnglujae (dnvfldtemq, 35.9) View more	-	14 Jul 2014
				rHuPH20+Humalog (Stage 1: Humalog + rHuPH20)	sxxhqwjpjp(nevuvcuilz) = gygytabcli dphnglujae (dnvfldtemq, 7.99) View more
NCT00979875 (CTgov)	Phase 1	-	14	Glulisine (Glulisine Alone)	uwhyrnwkxx(yjfthxwszq) = oljcvpadtu tfppjngznl (lgpjzyshgh, 4085.00) View more	-	14 Jul 2014
				Glulisine+rHuPH20 (Glulisine + rHuPH20)	uwhyrnwkxx(yjfthxwszq) = ftscczolme tfppjngznl (lgpjzyshgh, 6657.73) View more
NCT00916357 (Pubmed \| Diabetes Technol Ther)	Phase 2	Diabetes Mellitus, Type 2	21	Insulin Lispro with Hyaluronidase	aeibjqnwmd(feclkkldzm) = mjlgbgvkmf ucgcppjgux (nzfavkcvco ) View more	Positive	01 Mar 2012

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