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

Maintenance of Minimal Manifestation Status with Individualized-Interval Efgartigimod in Generalized Myasthenia Gravis: Study Protocol for a Single-Arm, Open-Label Clinical Trial. (PubMed, Neurol Ther) - "We designed a prospective study to evaluate maintenance of MM with low-dose oral prednisolone (PSL) ≤ 5 mg/day (MM-5 mg) under interval-adjusted efgartigimod administration. Graphical Abstract available for this article. Japan Registry of Clinical Trials (jRCT): jRCTs031260127 (prospectively registered on 14 May 2026)."

Journal • CNS Disorders • Immunology • Myasthenia Gravis

Efgartigimod PH20 SC Reduces Total Immunoglobulin G and Myositis-Specific Autoantibodies in Adults With Active Idiopathic Inflammatory Myopathy: Phase 2 Data From ALKIVIA (ACR Convergence 2026) - P2/3 | "Consistent with prior studies and its mechanism of action, EFG led to rapid and sustained reductions in total IgG, as well as in pooled MSA assay signals specific for three major IIM subtypes compared with PBO. This reinforces FcRn inhibition as a mechanistically relevant therapeutic approach, underscoring the role of autoantibodies in the pathophysiology of the disease."

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

Precision Over Prednisone: Mechanism-Based Therapy for Dermatomyositis in the Modern Era (ACR Convergence 2026) - "Learning Objectives: • Using a case-based approach, Explain the rationale for use of immunoglobulin therapy in myositis, with special emphasis in conditions where clinical trial data is available to guide its implementation • Identify practical scenarios where IVIG therapy is indicated and potential pitfalls commonly encountered with IVIG therapy, to aid clinicians in optimizing treatment of patients • Explain critical pathways in the pathogenesis of dermatomyositis, with an emphasis on insights derived from targeted inhibition of interferon-beta and type I interferon more broadly, as well as signaling through TYK2/JAK1 • Critically assess potential future approaches targeting autoantibodies, specifically reviewing clinical trials involving FcRn inhibitors for myositis as well as other immune-mediated diseases Idiopathic inflammatory myopathies (IIM) are a group of complex and heterogeneous disease entities, and clinicians face significant challenges in managing these..."

Dermatomyositis • Immunology • Myositis • TYK2

Polaris: A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: argenx | Trial completion date: May 2029 ➔ Jul 2030 | Initiation date: Aug 2026 ➔ Apr 2027 | Trial primary completion date: Jan 2029 ➔ Jul 2030

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Immunology

Cost comparison of intravenous immunoglobulin and subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyneuropathy. (PubMed, J Med Econ) - "To compare the total treatment costs and cost per responder of IVIG and a newer therapy for adults with chronic inflammatory demyelinating polyneuropathy from a U.S. payer perspective. While no head-to-head clinical trial data were available, differences in trial design and responder definitions between studies may affect comparability. Under the assumptions of this model, Panzyga-based treatment pathways were associated with lower modeled total treatment costs and lower estimated cost per responder than Vyvgart hytrulo at both 6 and 12 months."

Clinical • HEOR • Journal • Reimbursement • US reimbursement • Pain

Efgartigimod PH20 Subcutaneous in Adults With Systemic Sclerosis: Design of a Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study (eSScape) (EADV 2026) - No abstract available

Clinical • P2 data • Immunology • Scleroderma • Systemic Sclerosis

Results from the Phase 3 Uplighted Studies of Subcutaneous Efgartigimod in Thyroid Eye Disease: Efficacy, Safety, and Impact on IgG and TSH Receptor Autoantibodies (ATA 2026) - No abstract available

Clinical • P3 data • Ophthalmology • Thyroid Eye Disease

Phase 3 Randomized-Controlled Trials Evaluating Efficacy and Safety of Subcutaneous Efgartigimod PH20 Using Pre-Filled Syringes in Patients with Graves' Disease Inadequately Controlled with Antithyroid Drugs: Trials in Progress (ATA 2026) - No abstract available

Clinical • P3 data • Endocrine Disorders • Grave’s Disease

Safety of Intravenous and Subcutaneous Efgartigimod Reported from Multiple Global Clinical Trials in Immunoglobulin G-Mediated Autoimmune Diseases (ATA 2026) - No abstract available

Clinical • Immunology

ARGX-113-2207: A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis (clinicaltrials.gov) - P2/3 | N=12 | Recruiting | Sponsor: argenx | Trial completion date: Sep 2026 ➔ Sep 2027 | Trial primary completion date: Sep 2026 ➔ Sep 2027

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

Efficacy and safety of subcutaneous efgartigimod with prednisone in moderate-to-severe pemphigus (ADDRESS): a global, phase III, randomised controlled, double-blind trial. (PubMed, Br J Dermatol) - P3 | "Subcutaneous efgartigimod PH20 in combination with systemic corticosteroids did not demonstrate clinical benefit over systemic corticosteroids alone in patients with moderate-to-severe pemphigus at 30 weeks, but it was well tolerated in this patient population."

Journal • P3 data • Dermatology • Immunology • Pemphigus Vulgaris

Practical Guidance on Initiating and Switching Targeted Immunotherapies in Generalised Myasthenia Gravis: A German-Austrian Expert Opinion Paper. (PubMed, Eur J Neurol) - "This expert statement provides a practice-oriented framework integrating current evidence and clinical experience to support individualised therapeutic decision-making in gMG."

Journal • CNS Disorders • Immunology • Myasthenia Gravis • Pediatrics

Safety of Intravenous And Subcutaneous Efgartigimod Reported From Multiple Global Clinical Trials in Immunoglobulin G-Mediated Autoimmune Diseases (ETA 2026) - "Efgartigimod was well tolerated and demonstrated a similar safety profile regardless of disease state, dosing regimen, and length of exposure."

Clinical • CNS Disorders • Dyslipidemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Myasthenia Gravis • Thrombocytopenia • Thrombocytopenic Purpura

Phase 3 randomized-controlled trials evaluating efficacy and safety of subcutaneous efgartigimod PH20 using pre-filled syringes in patients with Graves’ disease inadequately controlled with antithyroid drugs: Trials in Progress (ETA 2026) - "Safety and tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the EFG PH20 SC PFS will also be assessed. These parallel trials will explore the potential of EFG to target the pathogenic IgG antibodies underlying GD pathophysiology."

Clinical • P3 data • Endocrine Disorders • Grave’s Disease • Immunology • Ophthalmology • Thyroid Eye Disease

Long-term safety, tolerability, and efficacy of subcutaneous efgartigimod PH20 in generalized myasthenia gravis: final results from a phase 3 open-label extension study (ADAPT-SC+). (PubMed, Front Neurol) - P3 | "The results of ADAPT-SC+ demonstrate long-term safety, tolerability, and sustained efficacy of efgartigimod PH20 SC across various dosing approaches, building on previous studies to broaden options for individualizing treatment for patients with gMG. https://clinicaltrials.gov/study/NCT04818671, NCT04818671."

Clinical • Journal • P3 data • CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis • Novel Coronavirus Disease • Pain

Investigating the Pharmacokinetics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administered with a Prefilled Syringe. (PubMed, Adv Ther) - P1 | "These studies support the bioequivalence, safety, and feasibility of an efgartigimod PH20 SC PFS. Both participants with gMG or CIDP and lay caregivers successfully administered the full dose of the efgartigimod PH20 SC PFS. Rapid-administration efgartigimod PH20 SC PFS is safe and feasible for both patients with autoimmune diseases and lay caregivers."

Journal • CNS Disorders • Immunology • Myasthenia Gravis • Pain

Polaris: A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology

A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: argenx

New P1 trial

argenx S…announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. (argenx Press Release) - "In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, patients treated with efgartigimod demonstrated statistically significant and clinically meaningful 15.4-point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo (47.95 vs 32.56)...In prespecified subtype analyses, the primary endpoint of Mean TIS at 52 weeks was also met in IMNM patients treated with efgartigimod (p=0.0048)..."

P3 data: top line • Dermatomyositis • Immunology • Myositis

A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY) (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: argenx

New P2 trial • Sjogren's Syndrome

Successful Recovery from Life-Threatening Ventilatory Failure with Efgartigimod in Seronegative Myasthenia Gravis: Two Case Reports. (PubMed, Case Rep Neurol) - "Efgartigimod was effective in treating myasthenic crisis requiring mechanical ventilation in seronegative generalized myasthenia gravis, regardless of autoantibody status. These cases suggest efgartigimod may serve as an alternative or adjunctive therapeutic option for severe myasthenia gravis exacerbations."

Journal • Anesthesia • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Myasthenia Gravis • Pulmonary Disease • Respiratory Diseases

Nipocalimab Effect On Immunoglobulin G Subclasses In Patients With Generalized Myasthenia Gravis (CNSF 2026) - "Nipocalimab significantly inhibits FcRn-mediated IgG recycling, leading to rapid, greater and sustained reductions in all IgG subclasses and pathogenic anti-AChR autoantibodies in gMG compared with efgartigimod and rozanolixizumab, highlighting its therapeutic potential."

Clinical • CNS Disorders • Myasthenia Gravis

ADAPT Forward2: ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • CNS Disorders • Myasthenia Gravis

ALKIVIA: A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. (clinicaltrials.gov) - P2/3 | N=265 | Completed | Sponsor: argenx | Recruiting ➔ Completed | Trial completion date: Feb 2027 ➔ Jul 2026 | Trial primary completion date: Dec 2026 ➔ Jul 2026

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

Expanding global VYVGART opportunity and shaping the long-term future of FcRn (argenx Press Release) - "Topline results from registrational ALKIVIA study (myositis) expected in third quarter of 2026; Topline results from registrational ADVANCE-NEXT study (primary ITP) expected in first half of 2027....VYVGART SC autoinjector positioned to launch in 2027 for all approved indications....Product net sales of VYVGART for the three and six months ended June 30, 2026, were $1.5 billion and $2.8 billion, respectively, compared to $0.9 billion and $1.7 billion, respectively, for the same periods in 2025."

Launch • P2/3 data • P3 data • Sales • Immune Thrombocytopenic Purpura • Myasthenia Gravis • Myositis