Imaavy (nipocalimab-aahu) / J&J - LARVOL DELTA

Immunosuppressive and immunomodulatory therapies in Sjögren's disease: current landscape and future perspectives. (PubMed, Expert Opin Pharmacother) - "CAR-T cell therapy application in refractory SjD patients currently represents an emerging, strictly experimental approach requiring rigorous evaluation of safety and long-term feasibility. Ultimately, identifying the most effective therapeutic agents will likely require discovering and implementing biomarkers tailored to specific biological endotypes."

IO biomarker • Journal • Review • Immunology • Sjogren's Syndrome • CD40LG • CTLA4

Nipocalimab For Warm Autoimmune Hemolytic Anemia: Results From a Phase 2/3 Randomized Double-blind Study (ACR Convergence 2026) - No abstract available

Clinical • P2/3 data • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

Assessing the Patient Experience of Nipocalimab: Exit Interviews from the Phase 2 Randomized Placebo-Controlled Study in Sjogren's Disease (ACR Convergence 2026) - No abstract available

Clinical • Interview • P2 data • Sjogren's Syndrome

Biomarker-Driven Insights to Clinical Response with Nipocalimab: A Phase 2 Randomized Trial for Sjögren's Disease (ACR Convergence 2026) - No abstract available

Biomarker • Clinical • P2 data • Sjogren's Syndrome

ClinESSDAI versus ESSDAI for Assessing Treatment Effects in Sjögren's Disease: Findings from the Phase 2 DAHLIAS Trial of the FcRn Blocker Nipocalimab (ACR Convergence 2026) - No abstract available

P2 data • Sjogren's Syndrome

Nipocalimab Phase 3 Dose Selection for Severe Hemolytic Disease of the Fetus and Newborn. (PubMed, J Clin Pharmacol) - P3 | "Simulations incorporating PK/PD variability indicated that 45 mg/kg weekly per current weight maintained full FcRn occupancy in >95% of pregnant individuals, even with dosing delays up to 3 days. Exploratory exposure-response analyses supported 45 mg/kg for the Phase 3 HDFN study."

Clinical • Journal • P3 data • Hematological Disorders

Paediatric outcomes after maternal nipocalimab for haemolytic disease of the fetus and newborn: an open-label, single-arm study. (PubMed, Arch Dis Child Fetal Neonatal Ed) - P2 | "Maternal nipocalimab in pregnancies at high risk of EOS-HDFN may reduce adverse neonatal outcomes correlating with low cord-blood alloantibody titres, without affecting growth through 6 months, neurodevelopment or HRQoL through 24 months of life."

Journal • Developmental Disorders • Pediatrics

Efficacy and Safety of Nipocalimab in Participants with Idiopathic Inflammatory Myopathies: Results from the Phase 2 SPIREA Trial through 52 Weeks (ACR Convergence 2026) - No abstract available

Clinical • P2 data • Myositis

Improvement in Executive Function Following Nipocalimab Treatment in Patients with Sjögren's Disease: A Randomized Clinical Trial (ACR Convergence 2026) - No abstract available

Clinical • Sjogren's Syndrome

Relationship Between IgG Levels and Infection Rates in Nipocalimab Treated Participants With Systemic Lupus Erythematosus (SLE) in the Phase 2 JASMINE-SLE Study (ACR Convergence 2026) - No abstract available

P2 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Pharmacodynamics of Nipocalimab, a Fully Human FcRn-Blocking Monoclonal Antibody, in Adults With Systemic Lupus Erythematosus: Results From a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study (JASMINE-SLE) (ACR Convergence 2026) - No abstract available

Clinical • P2 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Nipocalimab in SLE: First-in-Class Efficacy and Safety Results Demonstrating Proof of Concept For FcRn Blockade From a Phase 2 study (ACR Convergence 2026) - No abstract available

Clinical • P2 data • Inflammatory Arthritis

Efficacy of nipocalimab in patients with moderate-to-severe ocular symptoms of generalized myasthenia gravis in the phase 3 Vivacity-MG3 study. (PubMed, Expert Opin Biol Ther) - P3 | "These hypothesis-generating results suggest nipocalimab may provide sustained disease control, reduce ocular symptoms, and improve activities-of-daily-living versus placebo in participants with gMG and moderate-to-severe ocular symptoms. www.clinicaltrials.govidentifier is NCT04951622;www.clinicaltrialsregister.euidentifier is 2020-005732-29."

Journal • CNS Disorders • Immunology • Myasthenia Gravis

Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized, double-blind ENERGY study. (PubMed, Blood) - P2/3 | "Mean percent (SD) reduction in average daily prednisone dose (key secondary endpoint) was 15.1% (28.2) for nipocalimab 30 mg/kg IV q4w (nominal P=0.039) and 14.0% (30.4) for 15 mg/kg IV q2w (nominal P=0.055) versus 3.9% (16.33) for placebo. Overall, in the double-blind ENERGY study, nipocalimab demonstrated rapid hemoglobin response and nominal improvements in fatigue that were maintained over 24 weeks, with no new safety findings in wAIHA. NCT04119050."

Clinical • Journal • P2/3 data • Anemia • Autoimmune Hemolytic Anemia • Fatigue • Hematological Disorders • Immunology

Bridging the Gap in Sjögren's Disease: A Comprehensive Review of Unmet Needs, Diagnostic Challenges, and Emerging Therapeutic Strategies. (PubMed, Cureus) - "No disease-modifying therapy is currently approved for SjD, and management remains largely symptomatic, centered on artificial tears, sialogogues, and hydroxychloroquine, none of which reliably arrest systemic immunopathology. Finally, emerging therapeutic strategies are highlighted, including B-cell/BAFF-receptor-targeted ianalumab, the FcRn blocker nipocalimab, and the CD40-CD40L pathway inhibitor dazodalibep, which have demonstrated promising efficacy signals in randomized controlled trials. Improving outcomes in SjD will require earlier recognition, more consistent application of validated outcome measures in routine practice, and rational adoption of emerging immunoselective therapies guided by biomarker-based patient stratification."

IO biomarker • Journal • Review • Cognitive Disorders • Fatigue • Hematological Malignancies • Immunology • Lymphoma • Oncology • Pain • Rheumatology • Sjogren's Syndrome • CD40LG

Johnson & Johnson…announced the U.S. Food and Drug Administration (FDA) approval of IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA)…in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids (PRNewswire) - "The primary endpoint of the Phase 2/3 ENERGY study was durable hemoglobin (Hgb) response, a stringent endpoint definition that reflects meaningful increases in Hgb levels over time. The randomized, placebo-controlled trial demonstrated approximately three times as many patients receiving the approved dose of IMAAVYg achieved durable Hgb levels versus placebo by 24 weeks."

FDA approval • Autoimmune Hemolytic Anemia

Red blood cell alloimmunization and pregnancy: Diagnosis and management. (PubMed, Pregnancy (Hoboken)) - "Alternative therapeutic approaches, including intravenous immunoglobulin and plasmapheresis have been reported to delay or reduce the need for intrauterine transfusions, whilst the use of the neonatal Fc receptor inhibitor nipocalimab is currently under investigation...A multidisciplinary management involving obstetrician, neonatologist, hematologist, and transfusion specialist is essential for optimizing outcomes. In this review, we provide an overview of the pathophysiology, diagnosis, management, and treatment options for red blood cell alloimmunization and HDFN."

Journal • Review • Hematological Disorders • Obstetrics

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P2/3 | N=201 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2029 ➔ Jul 2028

Trial completion date

Pediatric Extrapolation in Neuropsychiatric Drug Development: Leveraging Pharmacokinetic and Pharmacodynamic Strategies to Facilitate FDA Approvals. (PubMed, Clin Pharmacol Ther) - "Case examples spanned broad age ranges, from mechanistically informed neonatal applications utilizing enzyme maturation modeling (risdiplam) to adolescent populations where adult dosing regimens proved adequate (brexanolone, nipocalimab). Additionally, pharmacodynamic biomarkers were pivotal in pediatric extrapolation of eculizumab and nipocalimab efficacy for the treatment of generalized myasthenia gravis, highlighting promising future directions for the field. These cases demonstrate how achieving comparable pharmacokinetics and, when necessary, pharmacodynamics profiles between adult and pediatric populations can support efficient regulatory approval without dedicated pediatric efficacy studies. The regulatory pathways established for select neuropsychiatric indications provide a compelling framework for expanding extrapolation approaches to other therapeutic areas."

FDA event • Journal • PK/PD data • Review • CNS Disorders • Myasthenia Gravis • Pediatrics • Psychiatry

Vibrance-MG: A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis (clinicaltrials.gov) - P2/3 | N=12 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial primary completion date • CNS Disorders • Myasthenia Gravis

Safety Profile of Nipocalimab, a New Neonatal Fragment Crystallizable Receptor Blocker in the Phase 3 Vivacity-MG3 Study (CNSF 2026) - "Nipocalimab was generally well-tolerated in adults with gMG, with no new safety concerns identified over a follow-up period of 96-weeks."

Clinical • P3 data • CNS Disorders • Myasthenia Gravis

Clinical efficacy and cost per improved outcome of treatments for generalized myasthenia gravis: evidence from a network meta-analysis and cost-per-responder analysis. (PubMed, Curr Med Res Opin) - "A de novo NMA was performed using data from Phase III placebo-controlled trials of efgartigimod IV, inebilizumab, nipocalimab, ravulizumab, rozanolixizumab, and zilucoplan, including recently approved therapies. Efgartigimod IV had the lowest CPIO across all QMG and MG-ADL thresholds, significantly lower than almost all other treatments (p < 0.05). Among approved effective biologic therapies for gMG, efgartigimod IV offers a favorable combination of clinical efficacy and economic value."

HEOR • Journal • Retrospective data • CNS Disorders • Myasthenia Gravis

Fatigue Assessed By Neuro-Quality Of Life In Phase 3 Vivacity-Mg3 Trial Of Nipocalimab Versus Placebo In Generalized Myasthenia Gravis (CNSF 2026) - "Nipocalimab+SOC-treated patients showed improvement on Neuro-QoL-Fatigue as-early-as W4. Nipocalimab+SOC-treated patients were also significantly more likely to sustain MWPI over time. Patients with more severe disease at baseline showed numerically greater improvements with nipocalimab+SOC than placebo+SOC."

Clinical • HEOR • P3 data • CNS Disorders • Myasthenia Gravis

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

From Molecular Pathophysiology to Clinical Trial Design in Sjögren's Disease: A Three-Axis Framework. (PubMed, Int J Mol Sci) - "Recent positive trials-phase III for ianalumab in NEPTUNUS-1/2, phase 2b for iscalimab in TWINSS, phase 2 for nipocalimab in DAHLIAS, and phase 2 for dazodalibep in a phenotype-defined symptom-dominant cohort-illustrate that meaningful clinical benefit becomes detectable once stratification is aligned to biology. By integrating molecular endotypes, validated biomarkers, composite endpoints, and phenotype-matched therapies onto a single explicit architecture, SjD shifts from a recurring example of translational failure to a model for precision medicine in heterogeneous autoimmune disease. The central message is that SjD may be less intrinsically treatment-resistant than it has historically been treatment-mistargeted."

Biomarker • Journal • Review • Immunology • Rheumatology • Sjogren's Syndrome