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

Advances in the treatment of autoimmune nodopathy: based on treatment strategies of CIDP. (PubMed, Front Immunol) - "Emerging therapeutic strategies are also being explored, among which subcutaneous injection of efgartigimod, a recently approved drug, is gradually accumulating clinical application value. The treatment strategy for AN differs from that of CIDP: Rituximab is currently regarded as the preferred option for treating AN, with corticosteroids being effective for some patients...Due to the low incidence of AN and the limited clinical evidence available, its treatment strategies still require large-scale clinical trials for validation. This article systematically reviews the treatment advancements for CIDP and focuses on the unique treatment strategies for AN."

Journal • Review • Immunology • Pain • CNTN • CNTN1

Real-World Application of Subcutaneous Efgartigimod in Chronic Inflammatory Demyelinating Polyradiculoneuropathy. (PubMed, Intern Med) - "No serious adverse events occurred, although one patient reported mild post-injection fatigue. These findings suggest that the clinical response to efgartigimod varies even within typical CIDP, likely due to underlying disease heterogeneity, thereby underscoring the need for larger studies to identify the predictors of treatment responsiveness."

Journal • Real-world evidence • Fatigue • Pain

A prospective real-world study of efgartigimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy. (PubMed, Front Immunol) - "This study demonstrates the short-term efficacy and safety of efgartigimod in treating CIDP, suggesting its potential as a safe and effective alternative therapy. Further exploration is needed to determine its suitability for long-term maintenance treatment of CIDP."

Journal • Real-world evidence • Pain

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

Clinical • P2 data • Immunology • Scleroderma • Systemic Sclerosis

The Long-Term Safety and Efficacy of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy: Results From the Phase 2 Randomized ALKIVIA and Open-Label Extension ALKIVIA+ Trials (EULAR 2026) - No abstract available

Clinical • P2 data • Myositis

UplighTED: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. (clinicaltrials.gov) - P3 | N=105 | Terminated | Sponsor: argenx | Active, not recruiting ➔ Terminated; The pre-defined interim analysis concluded that continuing the trials is unlikely to demonstrate the intended efficacy. This decision is not related to safety concerns, and the safety profile of efgartigimod remains unchanged

Trial termination • 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=102 | Terminated | Sponsor: argenx | Active, not recruiting ➔ Terminated; The pre-defined interim analysis concluded that continuing the trials is unlikely to demonstrate the intended efficacy. This decision is not related to safety concerns, and the safety profile of efgartigimod remains unchanged.

Trial termination • Ophthalmology • Thyroid Eye Disease

PHYSICIAN INSIGHTS ON CIDP CARE IN CANADA: UNMET NEEDS, ACCESS BARRIERS, AND EFGARTIGIMOD SC (ISPOR 2026) - "Insights from Canadian neurologists underscore the limitations of traditional CIDP therapies and the urgent need for system-level innovation. These findings support equitable access to novel options such as efgartigimod to address critical unmet needs and improve outcomes for patients living with CIDP."

HEALTHCARE RESOURCE UTILIZATION AND COSTS IN JAPANESE PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS INITIATING EFGARTIGIMOD: A REAL-WORLD RETROSPECTIVE ANALYSIS (ISPOR 2026) - "Initiation of EFG in Japanese adults with gMG was associated with meaningful reductions in hospital admissions, total LoS, ICU admissions, and inpatient costs, supporting its real-world effectiveness in this population."

HEOR • Real-world • Real-world evidence • Retrospective data • CNS Disorders • Immunology • Myasthenia Gravis

Long-term Safety and Efficacy of Subcutaneous Efgartigimod PH20 in Adult Participants With Generalized Myasthenia Gravis: Final Results of the ADAPT-SC+ Study (AAN 2026) - "Long-term treatment with efgartigimod PH20 SC was well tolerated and efficacious."

Clinical • CNS Disorders • 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 (AAN 2026) - P3 | "ADAPT OCULUS is the first Phase 3 clinical trial to address the unmet need for treatment in oMG by evaluating the safety and efficacy of efgartigimod PH20 SC in participants with oMG."

Clinical • CNS Disorders • Myasthenia Gravis

Characteristics of Real-world Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Initiating Subcutaneous Efgartigimod in United States (AAN 2026) - "Majority of SC-EFG initiators with CIDP had neuropathic pain and prior exposure to CIDP therapies, reflecting high disease burden. Yet, a substantial subset had not received any CIDP treatment in the preceding year, highlighting the potential role of SC-EFG in addressing both treated and undertreated patient populations."

Clinical • Real-world • Real-world evidence • Cardiovascular • CNS Disorders • Dyslipidemia • Hypertension • Metabolic Disorders • Myasthenia Gravis • Neuralgia • Pain

Physician Insights on Transitioning Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy From Intravenous Immunoglobulin to Subcutaneous Efgartigimod PH20 (AAN 2026) - "Successful transition from IVIg to efgartigimod PH20 SC can be achieved with attention to clinical considerations, expectation setting, and appropriate monitoring. Early adjustments to treatment may be necessary to support positive patient outcomes."

Clinical • Infectious Disease • Pain

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 (AAN 2026) - P2 | "The efficacy and safety of efgartigimod, a human immunoglobulin (Ig)G1 antibody Fc fragment, were assessed in ADHERE (NCT04281472), the largest CIDP trial to date... The ADHERE trial represents the most extensive dataset of patients with CIDP ever evaluated for NfL. Mirroring previous results, a correlation was identified between baseline NfL levels and CDAS scores, with higher levels indicating more active disease. Although NfL levels could not differentiate between typical and atypical CIDP, it may serve as a contextual biomarker, alongside clinical assessment."

Biomarker • Inflammation • NEFL

Clinical Experience With Subcutaneous Efgartigimod PH20 in Patients With Newly Diagnosed Chronic Inflammatory Demyelinating Polyradiculoneuropathy (AAN 2026) - P2 | "4 out of 5 newly diagnosed treatment-naïve typical CIDP patients continued to respond to efgartigimod PH20 SC at the end of 6 months with minor local site reactions."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Pain • Urticaria

Real-world Effectiveness and Use of Efgartigimod in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: ADHERE REAL Study Design (AAN 2026) - "This study will expand on the results of the registrational ADHERE trial, providing valuable real-world insights about the long-term use of efgartigimod treatment in patients with CIDP."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Pain

Efgartigimod is a Unique FcRn Blocker That Allows IgG Reduction Without Broad Inhibition of Immune Responses (AAN 2026) - "Efgartigimod's unique structure as an Fc fragment selectively reduces IgG antibodies and autoantibodies while preserving the ability to mount antigen-specific responses to immunization. This mechanism avoids both broader impacts on immunity and increased risk of infections observed with some immunosuppressive and B-cell–depleting therapies."

CNS Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Myasthenia Gravis • Pemphigus Vulgaris • Thrombocytopenia • Thrombocytopenic Purpura

Severe Clinical Deterioration Following Plasma Exchange Transition to Subcutaneous Efgartigimod in Refractory CIDP (AAN 2026) - "After six months of treatment with PLEX twice weekly, methylprednisolone IV 500 mg weekly and Cellcept 1000 mg twice daily, she returned to work as a police officer with complete independence (INCAT 1). It is unknown which CIDP patients will respond to efgartigimod. Although neonatal FcRn blockers have been deemed a chemical form of PLEX, their efficacy and speed to achieve clinical effect in refractory CIDP may not be equal to plasmapheresis. Furthermore, the exact dosage of efgartigimod in patients undergoing concomitant PLEX has not been established."

Clinical • NEFL

Impact of Subcutaneous Efgartigimod PH20 on Treatment-naïve Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in the ADHERE Trial: Post Hoc Analyses (AAN 2026) - P2 | "Efgartigimod PH20 SC treatment demonstrated a high level of response rate with quick onset of response in CIDP treatment-naïve participants. These findings address the evidence gap for treatment-naïve patients, an underrepresented population in CIDP research."

Retrospective data • Pain

argenx to Present New Data at 2026 AAN Annual Meeting that Continue to Transform Patient Outcomes in MG and CIDP and Build Upon Strength of Pipeline (argenx Press Release) - "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....Additional results from the ARGX-119 Phase 1b trial evaluating adimanebart in patients with DOK7 congenital myasthenic syndromes (CMS) will also be shared..."

Clinical data • Genetic Disorders • Immunology • Inflammation • Myasthenia Gravis

EFGARTIGIMOD PH20 SUBCUTANEOUS IN ADULTS WITH SYSTEMIC SCLEROSIS: A PHASE 2, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY (ESSCAPE) (SSWC 2026) - P2 | "This phase 2 study will evaluate efgartigimod PH20 SC as a potential treatment for patients with SSc."

Clinical • P2 data • Cardiovascular • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Fourth Quarter and Full-Year 2025 Financial Results (Businesswire) - "ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024...VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025..."

Platinum sensitive • Sales • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Myasthenia Gravis • Ovarian Cancer • Peritoneal Cancer

argenx Reports Full Year 2025 Financial Results… (GlobeNewswire) - "Generated $1.3 billion in global product net sales in the fourth quarter and $4.2 billion for the full year 2025, representing an increase of 90% or approximately $2 billion in year-over-year growth."

Commercial • Immunology • Myasthenia Gravis • Thrombocytopenic Purpura

argenx Announces Positive Topline Results from Phase 3 ADAPT OCULUS Trial of VYVGART in Ocular Myasthenia Gravis (GlobeNewswire) - "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....Data from the ADAPT OCULUS study will be presented at an upcoming medical meeting....Results support planned Supplemental Biologics License Application (sBLA) submission to U.S. Food and Drug Administration (FDA) to expand label into oMG."

FDA filing • P3 data: top line • Myasthenia Gravis

Halozyme Reports Full Year 2025 Record Revenue of $1.4 Billion… (PRNewswire) - "Three ENHANZE‑enabled blockbusters, DARZALEX SC, Phesgo and VYVGART Hytrulo, drove royalty revenue growth of 52%, reaching a record $868 million in 2025....The 38% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $867.8 million in royalties, an increase of 52% compared to $571.0 million in 2024, primarily driven by continued sales uptake of ENHANZE partner products..."

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