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

Nipocalimab for the treatment of moderate-to-severe Sjögren's disease: a plain language summary of the DAHLIAS study. (PubMed, Expert Rev Clin Immunol) - No abstract available

Journal • Sjogren's Syndrome

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 completion date: Jun 2026 ➔ Jul 2029

Trial completion date • CNS Disorders • Myasthenia Gravis

EPIC: Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=115 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2028 ➔ Dec 2028

Trial completion date • CNS Disorders • Myasthenia Gravis

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: Janssen Research & Development, LLC | N=14 ➔ 25

Enrollment change

Precision Immunomodulation in Pregnancy - Lessons from Nipocalimab. (PubMed, NEJM Evid) - No abstract available

Journal • Immunology

Infant Immunity after Maternal Nipocalimab in Severe Hemolytic Disease of the Fetus and Newborn. (PubMed, NEJM Evid) - P2 | "In this cohort of 12 live-born infants, antenatal treatment with nipocalimab resulted in low levels of detectable drug in fetal, neonatal, and infant samples. Treatment was associated with low IgG levels at birth; however, unusual or unexpected childhood illnesses or impaired vaccine responses were not observed. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT03842189.)."

Journal • Hematological Disorders • Infectious Disease • Tetanus

Imaavy: Data from P2 JASMINE trial (NCT04882878) for SLE in 2026 (J&J) - Q4 2025 Results

P2 data • Lupus • Systemic Lupus Erythematosus

Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study (J&J Press Release) - "Based on these positive topline results, the company plans to initiate a Phase 3 program for nipocalimab in SLE...The JASMINE study met the primary endpoint (percentage of patients achieving Systemic Lupus Erythematosus Responder Index [SRI-4] composite response at Week 24 with statistical significance compared with placebo), and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing. Nipocalimab had a safety and tolerability profile consistent with previous Phase 2 studies, with no new safety signals identified....Full results from the JASMINE study will be presented at a future medical congress."

New P3 trial • P2b data • Systemic Lupus Erythematosus

Novel Therapies for Generalized Myasthenia Gravis: Insights Into FcRn and Complement Inhibition. (PubMed, Am J Ther) - "These therapies offer personalized, effective options for MG management, though challenges in cost and access remain. Future research should address long-term outcomes and biomarkers."

Journal • Review • CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis

Nipocalimab in the management of generalized myasthenia gravis: a new targeted therapeutic approach. (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

The Ethics of Clinical Research on Diseases of the Fetus and Newborn: Balancing Benefit-Risk, Autonomy, and Maternal-Fetal Interests. (PubMed, Am J Perinatol) - "Early-onset severe HDFN was the initial indication for a phase 2 open-label study of nipocalimab in pregnancy, given poor outcomes after prior severe HDFN pregnancy(s)...· Placebo-controlled randomized trials in HDFN are based on equipoise.. · FNAIT programs must account for the off-label use of IVIg.."

Benefit-risk assessment • Journal • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia. (PubMed, Am J Perinatol) - "This article is a plain language summary of publication (PLSP) of the following articles: "Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-1)" by Tiller et al published in American Journal of Perinatology on July 28, 2025 (doi:10.1055/a-2666-5642) and "Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-3)" by Bussel et al published in American Journal of Perinatology on November 25, 2025 (doi: 10.1055/a-2753-9323). It provides information on the eligibility criteria, study design, treatments, and outcomes of interest. An infographic summary of this article is available in the Supplementary Material (available in the online version only)."

Journal • P3 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Body weight distribution of US patients with myasthenia gravis. (PubMed, J Med Econ) - "The dosing requirements of certain therapies (efgartigimod intravenous, nipocalimab, ravulizumab, rozanolixizumab, zilucoplan) are based on patient's body weight. The annual cost of health-care-provider-administered treatment for patients with gMG was estimated at $223,272-$648,960 depending on drug and body weight; annual cost was highest for patients who weighed >80 kg (up to $648,960 versus up to $467,044 for patients who weighed <80 kg). Our findings demonstrate that patients with MG may be heavier on average than previously assumed, which may influence the cost-effectiveness of gMG therapies with weight-based dosing."

Journal • CNS Disorders • Immunology • Myasthenia Gravis

Nipocalimab-aahu in generalised myasthenia gravis: A new Fc receptor-targeted option for antibody-positive patients. (PubMed, Ibrain) - "Key limitations include the need for long-term safety data and more research in underrepresented populations, including pediatric and seronegative patients. In conclusion, N-a represents a significant advancement in generalized MG (gMG) treatment, providing a targeted, effective, and well-tolerated option that addresses a key unmet need for patients with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody-positive disease."

Journal • CNS Disorders • Immunology • Infectious Disease • Myasthenia Gravis • Pain • Pediatrics

Assessing the Adoption of Novel Therapies in a Private/Public Payer System: A Study in Fitusiran, Sebetralstat, and Nipocalimab (ASHP 2025) - No abstract available

Structural hijacking of FcRn by human astrovirus spikes reveals conserved epitopes for broad-spectrum antivirals. (PubMed, Cell Rep) - "Mapping conserved epitopes across classical HAstV serotypes provides a blueprint for designing broad-spectrum antivirals that disrupt viral entry. Notably, our structural data rationalize the potential repurposing of clinical FcRn inhibitors, such as nipocalimab, to block HAstV infection, bridging critical gaps in astrovirus biology and antiviral development."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Pediatrics

Management of Autoimmune Hemolytic Anemia (ASH 2025) - "For relapsed/refractory patients rituximab has become the preferred second line-therapy, comparing favorably with the traditional splenectomy, which has been progressively abandoned or moved to further lines along with classic immunosuppressors. Several novel treatments are in development for wAIHA, encompassing drugs targeting B-cells (parsaclisib, ibrutinib, rilzabrutinib, zanubrutinib, obexelimab, ianalumab, povetacicept), plasma cells (bortezomib, daratumumab), spleen tyrosine kinase (fostamatinib, sovleplenib), and the neonatal Fc receptor (nipocalimab)."

IO biomarker • Anemia • Autoimmune Hemolytic Anemia • Bone Marrow Transplantation • Hematological Disorders • Immunology • Infectious Disease • HP • SYK

Nipocalimab: a significant milestone in the treatment of myasthenia gravis approved by the FDA. (PubMed, Ann Med Surg (Lond)) - "Late-stage trials have confirmed significant improvements in key health parameters, reinforcing the agent's therapeutic value. This biology introduces a more precise, well-tolerated, and durable option for treating myasthenia gravis."

FDA event • Journal • CNS Disorders • Immunology • Myasthenia Gravis

Management of autoimmune hemolytic anemia. (PubMed, Hematology Am Soc Hematol Educ Program) - "Rituximab is now the preferred second-line option for relapsed/refractory patients, comparing favorably with the traditional splenectomy. The latter is increasingly reserved for later lines together with classic immunosuppressants. Several novel treatments are in development for refractory wAIHA, encompassing drugs targeting B-cells (parsaclisib, ibrutinib, rilzabrutinib, zanubrutinib, obexelimab, ianalumab, povetacicept), plasma cells (bortezomib, daratumumab), spleen tyrosine kinase (fostamatinib, sovleplenib), and the neonatal Fc receptor (nipocalimab)."

Journal • Review • Anemia • Autoimmune Hemolytic Anemia • Bone Marrow Transplantation • Complement-mediated Rare Disorders • Hematological Disorders • Immunology • Infectious Disease • Oncology • Paroxysmal Nocturnal Hemoglobinuria • Transplantation • SYK

EPIC: Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=115 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

What is in the Neuromuscular Junction Literature? (PubMed, J Clin Neuromuscul Dis) - "The role of thymectomy in older patients with MG is considered. The medical treatment section addresses corticosteroid regimens, intravenous immunoglobulin as maintenance therapy, a phase 3 study of the recently approved neonatal Fc receptor (FcRN) blocker nipocalimab, use of complement inhibitors and FcRN blockers in general, regimens for efgartigimod, and positive studies on the interleukin-16 receptor monoclonal antibody (Ab) satralizumab and the CD19 B-cell-depleting monoclonal Ab inebilizumab."

Journal • Review • CNS Disorders • Myasthenia Gravis • Ophthalmology • Thyroid Eye Disease • IL16

Johnson & Johnson receives European Commission approval of IMAAVY (nipocalimab), a new FcRn blocker offering sustained disease control in a broad population of people living with generalised myasthenia gravis (gMG) (GlobeNewswire) - "This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive....This approval is supported by the data from the pivotal, ongoing Phase 3 Vivacity-MG3 study....This approval also includes data from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChR antibody-positive adolescents (aged 12–17 years) living with gMG."

EMA approval • Myasthenia Gravis

Design of a Phase 3, Multicenter, Randomized, Open-label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. (PubMed, Am J Perinatol) - "Exploratory endpoints include patient- and caregiver-reported outcome assessments and nipocalimab pharmacokinetics and pharmacodynamics. FREESIA-3, an open-label, multicenter, randomized, phase 3 study, will evaluate the efficacy and safety of nipocalimab in both standard-risk and high-risk pregnancies for FNAIT."

Clinical • Journal • P3 data • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Nipocalimab reduces Sjögren disease activity in phase II trial. (PubMed, Nat Rev Rheumatol) - No abstract available

Journal • P2 data • Sjogren's Syndrome

Nipocalimab for Sjögren's disease-the importance of autoantibodies. (PubMed, Lancet) - No abstract available

Journal • Sjogren's Syndrome