Nipocalimab

Johnson & Johnson's nipocalimab received FDA Priority Review for treating generalized myasthenia gravis (gMG) in antibody-positive patients, based on phase 3 study results showing significant symptom improvement. gMG, affecting ~700,000 globally, lacks a cure. Nipocalimab, also under EMA review, aims to reduce IgG antibodies without impacting other immune functions, offering potential treatment across various autoantibody diseases.

The FDA granted priority review to nipocalimab for treating generalized myasthenia gravis in antibody-positive patients, based on phase 3 trial data showing significant improvement in MG-ADL scores compared to placebo.

FDA granted Priority Review to Johnson & Johnson’s nipocalimab for treating generalized myasthenia gravis (gMG), based on Phase III Vivacity-MG3 study results showing significant MG-ADL score improvement. Nipocalimab plus standard care improved patients' strength and function, offering potential treatment for antibody-positive gMG patients.

Johnson & Johnson's nipocalimab, an FcRn blocker, has been granted FDA priority review for treating generalized myasthenia gravis (gMG), with a decision expected in Q3 2025. Supported by phase III Vivacity-MG3 study data, it shows sustained disease control in gMG patients. Nipocalimab faces competition from Argenx’s and UCB’s FcRn blockers. J&J is also exploring nipocalimab for other conditions.

Johnson & Johnson's nipocalimab, an FcRn blocker, seeks FDA approval for generalized myasthenia gravis (gMG) treatment, with a decision expected by Q3 2025. Supported by phase III Vivacity-MG3 study data, it shows sustained disease control in gMG patients. Nipocalimab faces competition from Argenx's and UCB's FcRn blockers. J&J is also exploring nipocalimab for other conditions.

Cyrus Biotechnology's CYR212, an AI-engineered IgG protease, targets the $20B autoimmune market with extended half-life and reduced immunogenicity. Preclinical data show rapid IgG depletion without immunogenicity, offering potential in treating IgG-mediated diseases like gMG and ITP, surpassing current anti-FcRn biologics in efficacy and convenience.

FDA grants priority review to Johnson & Johnson's nipocalimab for gMG treatment, following positive Phase III Vivacity-MG3 trial results showing superiority over placebo in MG-ADL scores. Nipocalimab also submitted for EMA approval and holds FDA Breakthrough Therapy Designation for Sjögren's disease.

Johnson & Johnson's nipocalimab received FDA Priority Review for treating generalized myasthenia gravis (gMG) in antibody-positive patients, supported by Phase 3 Vivacity-MG3 study results showing sustained disease control over 24 weeks. Nipocalimab demonstrated significant MG-ADL score improvement compared to placebo, highlighting its potential as a treatment option for gMG.

Johnson & Johnson's nipocalimab, targeting generalized myasthenia gravis in antibody-positive patients, received FDA priority review. This designation accelerates the review process for treatments offering significant improvements for serious diseases. Nipocalimab, part of J&J's $6.5 billion Momenta acquisition, is also being studied for other autoimmune conditions.

Johnson & Johnson's nipocalimab BLA received FDA Priority Review for treating generalized myasthenia gravis, based on Phase 3 Vivacity-MG3 study results, indicating potential significant treatment improvements.