Johnson & Johnson has halted its Phase 2a DAISY trial evaluating nipocalimab in combination with anti-TNFα therapy for rheumatoid arthritis patients with refractory disease, marking a strategic pivot toward rare diseases and maternal-fetal conditions where the FcRn blocker has demonstrated stronger clinical differentiation.
The combination therapy failed to demonstrate sufficient added benefit over anti-TNFα monotherapy at 12 weeks, leading J&J to abandon further development of the combination for rheumatoid arthritis. This decision, announced in June 2025, reflects what the company describes as a pragmatic reallocation of resources toward higher-conviction opportunities in its pipeline.
Established Success in Rare Diseases
Nipocalimab, now marketed as IMAAVY, has already secured FDA approval for generalized myasthenia gravis (gMG) and is advancing in rare maternal-fetal conditions. The drug's mechanism of action involves blocking the FcRn receptor to reduce pathogenic IgG levels while preserving immune function.
In gMG, the Phase 3 Vivacity-MG3 trial demonstrated sustained disease control, with patients achieving significant improvements in QMG and MG-ADL scores over 84 weeks. An indirect treatment comparison presented at the European Academy of Neurology 2025 Congress highlighted IMAAVY's superiority over competitors in sustained disease control, showing a 24-week advantage in MG-ADL scores.
The drug has also shown promise in Sjögren's syndrome, where it received Breakthrough Therapy designation after the Phase 2 DAHLIAS study demonstrated over 70% improvement in systemic disease activity in patients receiving 15 mg/kg doses.
Maternal-Fetal Market Opportunity
Nipocalimab's potential extends to maternal-fetal alloimmune diseases, particularly hemolytic disease of the fetus and newborn (HDFN) and fetal neonatal alloimmune thrombocytopenia (FNAIT). The UNITY trial showed that 54% of high-risk HDFN patients treated with nipocalimab achieved live births at or beyond 32 weeks without requiring intrauterine transfusion.
This outcome led to Breakthrough Therapy Designation for HDFN in February 2024, highlighting the drug's potential to disrupt a market with no approved therapies. The company has also received Orphan Drug and Fast Track designations for these indications, accelerating the path to approval and enhancing commercial exclusivity.
Strategic Rationale
The pivot away from rheumatoid arthritis reflects J&J's calculated approach to avoid direct competition with established players like AstraZeneca and UCB, which already dominate with other FcRn inhibitors in more common autoimmune conditions. Instead, the company is focusing on areas where competition is sparse and unmet medical need is acute.
J&J's differentiated approach leverages IMAAVY's pH-independent high-affinity binding to FcRn, which not only reduces pathogenic autoantibodies but preserves immune function. This mechanism creates what the company describes as a "moat" in IgG-driven diseases, particularly important in an era where broad immunosuppression remains a liability.
Regulatory and Commercial Outlook
The company's regulatory momentum includes a pending Marketing Authorization Application in the EU and multiple breakthrough designations. For rare diseases like HDFN and FNAIT, where IMAAVY is the only therapy in development, the commercial potential appears clear with premium pricing opportunities and regulatory incentives.
Long-term data from the Vivacity-MG3 open-label extension showing sustained IgG reduction and steroid tapering further reinforce the drug's durability in its approved indication. The company is also advancing trials in systemic lupus erythematosus and other autoimmune conditions, though these remain in early stages.
The strategic shift positions nipocalimab as what J&J considers a cornerstone of its immunology portfolio, focusing on high-conviction, high-reward indications backed by robust clinical data and regulatory momentum.
