Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) / argenx, ZAI Lab - LARVOL DELTA

Neonatal fc receptor antagonists in adult patients with primary immune thrombocytopenia: Systematic review and meta-analysis of randomized controlled trials (ASH 2025) - "Several FcRn inhibitors(namely efgartigimod, rozanolixizumab, and batoclimab) have shown promising results in clinical trials,but to date, no meta-analysis has synthesized randomized trial data to evaluate their efficacy and safetyin ITP.MethodsWe conducted a systematic review and meta-analysis of randomized, placebo-controlled trials evaluatingFcRn antagonists in adult patients with ITP. Despite the small number of short-duration trials and modest sample sizes, theconsistency of treatment effect and favorable safety profile support FcRn blockade as a promising andgenerally well-tolerated treatment option. Larger, longer-term studies are needed to confirm thedurability of response and better characterize the long-term safety profile."

Retrospective data • Review • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Challenges of Standard Treatments and Prospects for New Therapies (PubMed, Brain Nerve) - "Efgartigimod is a human IgG1 antibody fragment designed to reduce IgG including pathogenic IgG by binding to the neonatal Fc receptor and blocking the IgG recycling process...Other new therapies targeting complement pathways or B cells are under clinical development. (Received May 9, 2025; Accepted July 23, 2025; Published December 1, 2025)."

Journal • Review • Pain

ALKIVIA+: A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P3 | N=240 | Enrolling by invitation | Sponsor: argenx | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis • Rare Diseases

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: argenx

New trial • Real-world evidence • Pain

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis (clinicaltrials.gov) - P2/3 | N=12 | Enrolling by invitation | Sponsor: argenx | Trial completion date: Sep 2028 ➔ Sep 2029 | Trial primary completion date: Sep 2028 ➔ Sep 2029

Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

BioDigit MG-03: Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG (clinicaltrials.gov) - P=N/A | N=25 | Not yet recruiting | Sponsor: BioSensics

New trial • CNS Disorders • Myasthenia Gravis

Complement C5 Inhibitor (Anti-C5) and Neonatal Fc Receptor Antagonist Anti-FcRn in Myasthenia Gravis at University Public Hospitals of Paris, France (AP-HP): What Is the Market Share of These New Treatments? (ISPOR-EU 2025) - "This falls to 352 DDD in 2023 with the arrival of ravulizumab, then goes to 1861 DDD in 2024 despite the eculizumab biosimilar. Prescriptions are tending towards efgartigimod-IV, though ravulizumab continues to hold an important place, particularly in long-stay patients, where it replaces eculizumab and generates the highest costs. However, this trend could change with the arrival of subcutaneous forms available in community pharmacies (zilucoplan, efgartigimod-SC and rozanolixizumab), potentially modifying therapeutic practices and hospital costs."

Clinical • CNS Disorders • Myasthenia Gravis

PET-AON: Efgartigimod for the Treatment of Acute Optic Neuritis (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Anastasia Vishnevetsky, MD, MPH | Not yet recruiting ➔ Recruiting

Enrollment open • Ocular Inflammation • Ophthalmology • Optic Neuritis

Third Quarter 2025 Financial Results (Businesswire) - "VYVGART and VYVGART Hytrulo were $27.7 million in the third quarter of 2025 which includes a $2.4 million reduction following a voluntary price adjustment on Hytrulo ahead of National Reimbursement Drug List (NRDL) negotiation, compared to $26.5 million in the second quarter of 2025. Sales grew 4.6% quarter over quarter driven by an extension of duration of therapy and increased market penetration."

Sales • Myasthenia Gravis

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). (Canada Newswire) - "The Health Canada authorization is supported by positive results from the ADHERE study, the largest clinical trial conducted to date in CIDP."

Canada approval • Immunology

Third Quarter 2025 Financial Highlights (PRNewswire) - "Revenue was $354.3 million, compared to $290.1 million in the third quarter of 2024....Revenue included $236.0 million in royalties, an increase of 52% compared to $155.1 million in the third quarter of 2024, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly by VYVGART Hytrulo by argenx, DARZALEX SC by Janssen and Phesgo by Roche in all geographies."

Sales • HER2 Positive Breast Cancer • Multiple Myeloma • Myasthenia Gravis

Management of Myasthenic Crisis and Emerging Roles of Molecularly Targeted Therapies: A Narrative Review. (PubMed, Neurol Int) - "Conventional MCr treatments-such as plasma exchange (PLEX), intravenous immunoglobulin (IVIG), and intravenous methylprednisolone (IVMP)-remain standard treatments; however, they present significant limitations, including delayed onset of action, adverse effects, and inconsistent efficacy...We review published case reports involving FcRn inhibitors (efgartigimod, efgartigimod-SC, rozanolixizumab) and complement inhibitors (eculizumab, ravulizumab, zilucoplan), highlighting their rapid onset of action and safety profiles in MCr...We also discuss strategic considerations for therapy selection, including antibody subtype, coexisting autoimmune conditions, genetic factors, and transition to long-term maintenance. Though the current evidence is promising, large-scale randomized studies are needed to establish definitive roles for these therapies in MCr management."

Journal • Review • CNS Disorders • Critical care • Immunology • Myasthenia Gravis • Respiratory Diseases

New data from the 24-week phase 2 ALKIVIA study (NCT05523167)... (NeurologyLive) - "... showed that treatment with of subcutaneous (SC) efgartigimod (Vyvgart Hytrulo; argenx), a neonatal Fc receptor (FcRn) blocker, significantly reduced disease activity compared with placebo in patients with Idiopathic inflammatory myopathy (IIM), a rare autoimmune disorder with different subtypes...Findings showed that the least-squares mean of the Total Improvement Score (TIS) was statistically significantly higher in the efgartigimod treatment group in comparison with the placebo arm at 24 weeks (50.45 vs 35.65, 2-sided P=.0004)....Researchers reported that the key secondary end points of the trial were met, except for minimal clinical improvement, TIS of at least 20, at week 24 (91.5% vs 73.8%). Findings revealed that median times to a TIS of at least 20 and of at least 40 were significantly shorter with efgartigimod than with placebo (30 days vs 71.5 days, P = .0020; and 113 days vs not estimable, P = .0293, respectively)."

P2 data • Immunology

Chronic Inflammatory Demyelinating Polyneuropathy and Variants. (PubMed, Neurol Clin) - "IVIG remains the treatment of choice for induction or maintenance of remission, although corticosteroids, plasma exchange, and most recently, efgartigimod, demonstrate therapeutic efficacy. Subcutaneous immunoglobulin is indicated only as maintenance therapy. Validated outcome measures exist to track disability, strength, and quality of life and should be routinely employed in clinical practice."

Journal • Review • Pain

Efgartigimod Development (argenx Press Release) - "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 UNITY study (Sjögren’s disease) expected in 2027. Registrational study in Graves’ disease (GD) to initiate in first half of 2026....Topline results from UplighTED studies expected in second half of 2026."

New trial • P2/3 data • P3 data: top line • Dermatomyositis • Grave’s Disease • Sjogren's Syndrome • Thyroid Eye Disease

VYVGART SC prefilled syringe (PFS) for self-injection approved in Japan in September 2025; Canada decision on approval expected by end of 2025 (argenx Press Release)

Canada approval • Japan approval • Immune Thrombocytopenic Purpura

Demonstrating Sustained MSE and Favorable Safety Profile in Long-Term Treatment (AANEM Poster Presentation #12) (GlobeNewswire) - "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. Clinically meaningful improvements in mean MG-ADL total scores were observed in AChR-Ab+ participants as early as Week 1 and were sustained through Week 163. 59.2% of AChR-Ab+ participants achieved MSE (MG-ADL score of 0 or 1) at least once, while 88.1% of those sustained minimal symptom expression for at least 4 weeks."

P3 data • Myasthenia Gravis

Effective Subcutaneous Efgartigimod Treatment in a 90-Year-Old Female With Myasthenia Gravis. (PubMed, J Clin Neurol) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

Effect of Efgartigimod PH20 SC on Total Improvement Score, its Core Set Measures, and Patient/Clinician Impressions of Change: Results from the Phase 2 ALKIVIA Study of Adults with Active Idiopathic Inflammatory Myopathy (ACR Convergence 2025) - P2/3 | "ALKIVIA, the first FcRn inhibitor study in IIM, established proof of concept and highlights the mechanistic relevance of FcRn inhibition in IIM. Results support further evaluation of efgartigimod PH20 SC in patients with IIM in the ongoing phase 3 part of the study."

Clinical • P2 data • Dermatology • Dermatomyositis • Immunology • Myositis • Rare Diseases • Rheumatology

argenx to Highlight Key Data and Breadth of Immunology Innovation at 2025 AANEM Annual Meeting and MGFA Scientific Session (GlobeNewswire) - "Results from the Phase 3 ADAPT SERON study evaluating VYVGART for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody negative (AChR-Ab seronegative) show clinically meaningful improvements in disease activity across all three subtypes (triple negative, MuSK, and LRP4-Ab seropositive); ADAPT Jr interim results assess age-appropriate dosing, safety, and clinical effect of VYVGART in juvenile gMG...VYVGART Hytrulo CIDP data highlight functional improvement, long-term safety, and real-world characteristics of patients, underscoring the need for early treatment with effective and well-tolerated therapies; Two Phase 3 study designs for empasiprubart in CIDP – EMVIGORATE and EMNERGIZE – demonstrate argenx’s commitment to advancing innovative therapies and transforming outcomes for patients."

Clinical data • Clinical protocol • Immunology • Myasthenia Gravis

A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC (clinicaltrials.gov) - P4 | N=25 | Recruiting | Sponsor: argenx | Trial completion date: Sep 2025 ➔ Feb 2026 | Trial primary completion date: Sep 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Pain

UplighTED: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. (clinicaltrials.gov) - P3 | N=123 | Recruiting | Sponsor: argenx | Trial primary completion date: Feb 2026 ➔ Sep 2026

Trial primary completion date • Ophthalmology • Thyroid Eye Disease

UplighTED: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=123 | Recruiting | Sponsor: argenx | Trial primary completion date: Feb 2026 ➔ Sep 2026

Trial primary completion date • Ophthalmology • Thyroid Eye Disease

OPTIMAGE: Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Centre Hospitalier Universitaire de Nice | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

FUJIFILM Biotechnologies Expands Strategic Partnership with argenx to Include U.S. Manufacturing Operations (Businesswire) - "As part of the expanded agreement, FUJIFILM Biotechnologies will initiate manufacturing of argenx’ drug substance for efgartigimod at the Holly Springs, North Carolina, site in 2028....With the expanded global manufacturing agreement, argenx will benefit from FUJIFILM Biotechnologies’ global kojoX network, which provides local-for-local supply, manufacturing in close proximity to patients."

Commercial • Inflammation • Myasthenia Gravis