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JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab
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Johnson & Johnson (JNJ - Free Report) submitted abiologics license application (BLA) to the FDA seeking approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in generalized myasthenia gravis (gMG) indication.
The FDA filing is supported by data from the phase III Vivacity-MG3 study, which evaluated nipocalimab in adults with gMG, including those with anti-AChR, anti-MuSK and anti-LRP4 positive antibodies. Data from the study showed that patients who received nipocalimab plus standard of care (SOC) achieved sustained disease control over 24 weeks compared with those who received placebo plus SOC.
Per management, the above results make Vivacity-MG3 the first and only study to achieve sustained disease control in gMG patients with anti-AChR, anti-MuSK and anti-LRP4 positive antibodies. J&J claims that the study is the longest dataset available for a FcRn blocker in this indication.
gMG is an autoantibody-driven neuromuscular disease marked by fluctuating muscle weakness. Nipocalimab has been designed to block FcRn and reduce levels of autoantibodies while preserving immune function without causing broad immunosuppression.
JNJ Stock Performance
Year to date, J&J’s shares have moved up 4.8% compared with the industry’s 27.1% rise.
Image Source: Zacks Investment Research
Competition in the gMG Space
If approved, nipocalimab will enter a competitive market for gMG treatments. The J&J drug would face stiff competition from Argenx’s (ARGX - Free Report) Vyvgart/Vyvgart Hytrulo and Belgium-based UCB’s Rystiggo, both of which are also FcRn blockers and were approved last year in gMG indication.
While the Argenx drug is approved only in patients with anti-AChR positive antibodies, the UCB drug is approved for patients with anti-AChR and anti-MuSK positive antibodies. Argenx’s drug is also approved for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP).
JNJ’s Nipocalimab Development
J&J is evaluating nipocalimab across multiple immunology and neuroscience indications in separate mid-stage to late-stage clinical studies.
Management is evaluating the drug in late-stage studies for CIDP and hemolytic disease of the fetus and newborn (HDFN). The drug is also being evaluated in separate mid-stage studies for idiopathic inflammatory myopathy, Sjogren's disease, systemic lupus erythematosus and rheumatoid arthritis indications.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 87.4%.
BVS’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion. Bioventus delivered an earnings surprise of 102.86%, on average.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have rallied 29.5%.
Earnings of Fulcrum Therapeutics beat estimates in each of the trailing four quarters. Fulcrum delivered an earnings surprise of 393.18%, on average.
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JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab
Johnson & Johnson (JNJ - Free Report) submitted abiologics license application (BLA) to the FDA seeking approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in generalized myasthenia gravis (gMG) indication.
The FDA filing is supported by data from the phase III Vivacity-MG3 study, which evaluated nipocalimab in adults with gMG, including those with anti-AChR, anti-MuSK and anti-LRP4 positive antibodies. Data from the study showed that patients who received nipocalimab plus standard of care (SOC) achieved sustained disease control over 24 weeks compared with those who received placebo plus SOC.
Per management, the above results make Vivacity-MG3 the first and only study to achieve sustained disease control in gMG patients with anti-AChR, anti-MuSK and anti-LRP4 positive antibodies. J&J claims that the study is the longest dataset available for a FcRn blocker in this indication.
gMG is an autoantibody-driven neuromuscular disease marked by fluctuating muscle weakness. Nipocalimab has been designed to block FcRn and reduce levels of autoantibodies while preserving immune function without causing broad immunosuppression.
JNJ Stock Performance
Year to date, J&J’s shares have moved up 4.8% compared with the industry’s 27.1% rise.
Image Source: Zacks Investment Research
Competition in the gMG Space
If approved, nipocalimab will enter a competitive market for gMG treatments. The J&J drug would face stiff competition from Argenx’s (ARGX - Free Report) Vyvgart/Vyvgart Hytrulo and Belgium-based UCB’s Rystiggo, both of which are also FcRn blockers and were approved last year in gMG indication.
While the Argenx drug is approved only in patients with anti-AChR positive antibodies, the UCB drug is approved for patients with anti-AChR and anti-MuSK positive antibodies. Argenx’s drug is also approved for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP).
JNJ’s Nipocalimab Development
J&J is evaluating nipocalimab across multiple immunology and neuroscience indications in separate mid-stage to late-stage clinical studies.
Management is evaluating the drug in late-stage studies for CIDP and hemolytic disease of the fetus and newborn (HDFN). The drug is also being evaluated in separate mid-stage studies for idiopathic inflammatory myopathy, Sjogren's disease, systemic lupus erythematosus and rheumatoid arthritis indications.
JNJ Zacks Rank
J&J currently carries a Zacks Rank #4 (Sell).
Johnson & Johnson Price
Johnson & Johnson price | Johnson & Johnson Quote
Our Key Picks Among Biotech Stocks
A couple of better-ranked stocks include Bioventus (BVS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 87.4%.
BVS’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion. Bioventus delivered an earnings surprise of 102.86%, on average.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have rallied 29.5%.
Earnings of Fulcrum Therapeutics beat estimates in each of the trailing four quarters. Fulcrum delivered an earnings surprise of 393.18%, on average.