FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab

FDA Filing and Clinical Data - The FDA filing for nipocalimab is supported by data from the phase III Vivacity-MG3 study, which showed sustained disease control over 24 weeks in gMG patients receiving nipocalimab plus standard of care compared to placebo [1] - Vivacity-MG3 is the first and only study to achieve sustained disease control in gMG patients with anti-AChR, anti-MuSK, and anti-LRP4 positive antibodies, and it provides the longest dataset for an FcRn blocker in this indication [2] - Nipocalimab is designed to block FcRn, reduce autoantibody levels, and preserve immune function without causing broad immunosuppression [3] J&J Stock Performance - J&J's shares have lost 12% in the past year, compared to the industry's nearly 3% decline [4] Competitive Landscape in gMG - If approved, nipocalimab will compete with Argenx's Vyvgart/Vyvgart Hytrulo and UCB's Rystiggo, both of which are FcRn blockers approved for gMG [6] - Argenx's drug is approved for anti-AChR positive antibodies and chronic inflammatory demyelinating polyneuropathy (CIDP), while UCB's drug is approved for anti-AChR or anti-MuSK positive antibodies [7] Nipocalimab Development Pipeline - J&J is evaluating nipocalimab in multiple immunology and neuroscience indications, including late-stage studies for CIDP, hemolytic disease of the fetus and newborn (HDFN), and warm autoimmune hemolytic anemia (wAIHA) [9] - Mid-stage studies are ongoing for idiopathic inflammatory myopathy, Sjogren's disease, systemic lupus erythematosus, and rheumatoid arthritis [9] FDA Review Timeline - The FDA has granted priority review for nipocalimab, reducing the review period by four months, with a final decision expected in Q3 2025 [14] Other Biotech Stocks - Castle Biosciences (CSTL) has seen its 2024 bottom-line estimates improve from a loss of 8 cents per share to earnings of 34 cents per share, with shares surging 53% in the past year [12] - CytomX Therapeutics (CTMX) has narrowed its 2024 loss per share estimates from 18 cents to 5 cents, though its shares have lost 41% in the past year [13]