Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07669077 |
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women |
RECRUITING | PHASE1 |
| NCT07438496 |
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus |
RECRUITING | PHASE3 |
| NCT07217587 |
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis |
RECRUITING | PHASE3 |
| NCT06741969 |
Nipocalimab in Moderate to Severe Sjogren's Disease |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06533098 |
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) |
RECRUITING | PHASE3 |
| NCT06449651 |
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) |
RECRUITING | PHASE3 |
| NCT05912517 |
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) |
RECRUITING | PHASE3 |
| NCT05379634 |
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05327114 |
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
RECRUITING | PHASE2/PHASE3 |
| NCT05265273 |
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis |
RECRUITING | PHASE2/PHASE3 |
