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

Subcutaneous Efgartigimod PH20 for the Treatment of Thyroid Eye Disease in Adults (UplighTED): Study Design for Two Identical, Parallel, Phase 3, Randomized, Placebo-Controlled Studies (ATA 2025) - No abstract available

Clinical • P3 data • Ophthalmology • Thyroid Eye Disease

Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "ZL-1503 (IL-13/IL-31R): Zai Lab to advance into a global Phase 1 study in moderate-to-severe atopic dermatitis in the second half of 2025. Efgartigimod (FcRn): Lupus Nephritis (LN): Zai Lab and partner argenx to provide topline results from the Phase 2 study in LN in the fourth quarter of 2025. Seronegative gMG: Zai Lab partner argenx to provide topline results from the global Phase 3 ADAPT-SERON study in seronegative gMG in the second half of 2025. Zai Lab participated in the study in Greater China. Ocular myasthenia gravis: Zai Lab partner argenx to provide topline results from the global Phase 3 ADAPT-OCULUS study in the first half of 2026. Zai Lab participated in the study in Greater China. Sjogren's disease: Zai Lab to join the registrational UNITY study of efgartigimod subcutaneous given by prefilled syringe in Sjogren’s disease in Greater China in the third quarter of 2025."

New P1 trial • P2 data • P3 data: top line • Atopic Dermatitis • Lupus Nephritis • Myasthenia Gravis • Sjogren's Syndrome

Expand global VYVGART opportunity… (GlobeNewswire) - "PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year....Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS); Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT)."

Canada approval • Clinical data • Japan approval • Immune Thrombocytopenic Purpura • Immunology • Inflammation • Myasthenia Gravis • Thrombocytopenia

OPTIMAGE: A Multicenter, Prospective, Observational, Open-label Study to Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire de Nice

New P4 trial • CNS Disorders • Myasthenia Gravis

Trial Design of the Phase 2 Study SHAMROCK Evaluating the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Kidney Transplant Recipients with Antibody-Mediated Rejection (WTC 2025) - P2 | "Eligible patients must be receiving standard background immunosuppression therapy (SBIT) consisting of tacrolimus (TAC) plus mycophenolate mofetil (MMF), with or without steroids. This study will provide insights into the potential of efgartigimod PH20 SC administered by prefilled syringe as a treatment option in kidney transplant recipients with active or chronic active AMR."

Clinical • P2 data • Antibody-mediated Rejection • Transplantation

Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "VYVGART and VYVGART Hytrulo were $26.5 million in the second quarter of 2025, compared to $18.1 million in the first quarter of 2025. Sales grew 46% quarter over quarter driven by an extension of duration of therapy and increasing market penetration."

Sales • Immune Thrombocytopenic Purpura • Myasthenia Gravis • Thrombocytopenia

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG SECOND QUARTER 2025 RESULTS (PRNewswire) - "Revenue was $325.7 million, compared to $231.4 million in the second quarter of 2024. The 41% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenues. Revenue included $205.6 million in royalties, an increase of 65% compared to $124.9 million in the second quarter of 2024, primarily attributable to increases in revenue of...VYVGART Hytrulo..."

Sales • Myasthenia Gravis

Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe (GlobeNewswire) - "Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $949 million in the second quarter of 2025....First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP."

Launch Europe • Sales • Immune Thrombocytopenic Purpura • Immunology • Inflammation • Myasthenia Gravis

Argenx stock falls after FDA flags serious risk signal with Vyvgart (Investing.com) - "Argenx...stock tumbled 6% after the U.S. Food and Drug Administration (FDA) identified a potential serious risk associated with the company’s lead drug, Vyvgart. The FDA published a report highlighting a 'severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy' as a potential signal of serious risk with Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection. The regulatory agency stated it is currently evaluating the need for regulatory action. Vyvgart is Argenx’s flagship product, approved for treating generalized myasthenia gravis, a rare autoimmune disease. The identification of this safety concern comes at a critical time for the company, which has been positioning the medication as a key growth driver."

FDA event • Myasthenia Gravis

argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (argenx Press Release) - "argenx SE...announced that the European Commission (EC) approved VYVGART (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation....The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date."

EMA approval • Immunology

SAFETY PROFILE OF SUBCUTANEOUS EFGARTIGIMOD PH20 FROM CLINICAL TRIALS IN MYASTHENIA GRAVIS AND CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (EULAR 2025) - P2, P3 | "Efgartigimod PH20 SC was well-tolerated across indications and dosing regimens. Most TEAEs were mild to moderate in severity and did not increase in frequency with recurrent dosing."

Clinical • CNS Disorders • Infectious Disease • Myasthenia Gravis • Pain

Efficacy and safety of efgartigimod PH20 subcutaneous by prefilled syringe in adults with primary Sjögren's disease: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial with open-label extension (UNITY) (EULAR 2025) - P3 | "This phase 3 study with OLE will evaluate efgartigimod PH20 SC versus placebo in adult participants with clinESSDAI ≥6 (moderate-to-severe pSjD)."

Clinical • P3 data • Developmental Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology • Sjogren's Syndrome

Efficacy and safety of efgartigimod PH20 SC in adult participants with active idiopathic inflammatory myopathy: Phase 2 results from the ALKIVIA study (EULAR 2025) - P2/3 | "ALKIVIA is the first study of an FcRn inhibitor in IIM, establishing proof of concept. Efgartigimod PH20 SC led to significant improvement over placebo in TIS and key secondary endpoints with good safety and tolerability. The results demonstrate the mechanistic relevance of FcRn inhibition in IIM, indicating the potential pathogenicity of autoantibodies in IIM."

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

argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis… (GlobeNewswire) - P2/3 | N=240 | ALKIVIA (NCT05523167) | Sponsor: argenx | "argenx SE...announced the presentation of positive results from Phase 2 studies evaluating VYVGART...in...idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025.....In the ongoing, seamless ALKIVIA Phase 2/3 study evaluating three myositis subtypes (IMNM, ASyS, DM), data from Phase 2 show that patients demonstrated significant improvement in muscle strength and physical function when treated with efgartigimod....TIS improvement was observed in a majority of efgartigimod-treated patients across all six core measures, and the primary endpoint was met. Efgartigimod patients showed a significantly higher mean TIS of 50.45 compared to 35.65 in the placebo arm (2-sided P=0.0004). In addition, for patients treated with efgartigimod, 79% achieved a moderate improvement (TIS ≥40) and 34% achieved a major improvement (TIS ≥60)..."

P2 data • Myositis

Changes in intravenous or subcutaneous immunoglobulin usage before and after efgartigimod initiation in patients with Myasthenia Gravis (CNSF 2025) - No abstract available

Clinical • CNS Disorders • Myasthenia Gravis

Investigating the bioequivalence, injection speed, and usability of subcutaneous efgartigimod PH20 administration using a prefilled syringe (CNSF 2025) - No abstract available

CNS Disorders

Long-term efficacy of Efgartigimod PH20 SC in patients with chronic inflammatory demyelinating polyneuropathy: interim results from the ADHERE+ study (CNSF 2025) - No abstract available

Clinical • CNS Disorders • Pain

ADAPT-EARLY: A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Assessing VYVGART Social Media Data in Generalized Myasthenia Gravis To Understand Patient, Caregiver, and HCP Sentiment (ISPOR 2025) - "The number of online VYVGART posts grew significantly over the study timeframe, with patients highlighting improved QOL and access challenges, caregivers expressing improved patient performance of activities of daily living and access challenges, and HCPs sentiment was largely neutral."

Clinical • CNS Disorders • Myasthenia Gravis

Clinical experience with subcutaneous injection of efgartigimod in patients with anti-AchR antibody-positive myasthenia gravis (JSNE 2025) - No abstract available

Clinical • CNS Disorders • Myasthenia Gravis

argenx Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Efgartigimod Development...Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027."

P2 data • Immunology • Lupus Nephritis • Systemic Sclerosis

Expand the global VYVGART opportunity and launch VYVGART SC as a pre-filled syringe (GlobeNewswire) - "Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $790 million in the first quarter of 2025: Strong underlying fundamentals across key patient and prescriber metrics with 99% product net sales growth year-over-year from first quarter 2024, and 7% product net sales growth from fourth quarter 2024....Topline results from Phase 4 switch study to inform treatment decisions when switching patients on IVIg to VYVGART SC in CIDP expected in second half of 2025 and to be presented at an upcoming medical meeting."

P4 data • Sales • Immune Thrombocytopenic Purpura • Immunology • Myasthenia Gravis

Long-term efficacy of subcutaneous efgartigimod in patients with CIDP: interim results from the ADHERE+ trial (JSNE 2025) - No abstract available

Clinical

Zai Lab Announces First Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "Product revenue, net was $105.7 million in the first quarter of 2025, compared to $87.1 million for the same period in 2024, representing 21% y-o-y growth, 23% y-o-y growth at constant exchange rate (CER). This increase was primarily driven by increased sales for VYVGART, ZEJULA, and NUZYRA....VYVGART and VYVGART Hytrulo were $18.1 million in the first quarter of 2025, compared to $13.2 million for the same period in 2024....ZEJULA was $49.5 million in the first quarter of 2025, compared to $45.5 million for the same period in 2024. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China. NUZYRA was $15.1 million in the first quarter of 2025, compared to $9.9 million for the same period in 2024. This growth was supported by increasing market coverage and penetration."

Commercial • Infectious Disease • Myasthenia Gravis • Ovarian Cancer

ADHERE Study: Efficacy and Safety of Subcutaneous Efgartigimod in East Asian Patients with CIDP (JSNE 2025) - No abstract available

Clinical