JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab

Zacks08-31

Johnson & Johnson JNJ submitted abiologics license application (BLA) to the FDA seeking approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in generalized myasthenia ...

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Data from the study showed that patients who received nipocalimab plus standard of care achieved sustained disease controlover 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 ","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1506573853.SGD":"MANULIFE GF GLOBAL EQUITY \"AA\" (SGD) INC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","JNJ":"强生","LU0912757837.SGD":"JPMorgan Investment Funds - Global Income A (mth) SGD-H","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","BK4213":"石油与天然气的勘探与生产","BVS":"Bioventus Inc.","LU1162221912.USD":"FRANKLIN INCOME \"A\" (USD) ACC","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQ \"AU\" (USD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4592":"伊斯兰概念","LU1935042991.SGD":"MANULIFE GF GLOBAL MULTI-ASSET DIVERSIFIED INCOME  \"AA\" (SGDHDG) INC","LU1221951046.USD":"NORDEA 1 STABLE RETURN \"HM\" (USDHDG) INC","LU0234572021.USD":"高盛美国核心股票组合Acc","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","BK4585":"ETF&股票定投概念","LU1221951129.SGD":"NORDEA 1 STABLE RETURN \"HM\" (SGDHDG) INC","BK4139":"生物科技","SOC":"Sable Offshore Corp.","LU1267930813.SGD":"FRANKLIN TEMPLETON SHARIAH GLOBAL EQUITY \"AS\" (SGD) ACC","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","LU0345770308.USD":"NINETY ONE GSF GLOBAL STRATEGIC EQUITY \"A\" (USD) ACC","LU2347655156.SGD":"JPMorgan Investment Funds - Global Income A (icdiv) SGD-H","LU0795875086.SGD":"JPMorgan Investment Funds - Global Income A (div) SGD","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU0466842654.USD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"A\" (USD) ACC","LU1032466523.USD":"高盛全球多资产收益组合Acc","LU1196500208.SGD":"NORDEA STABLE RETURN \"HB\" (SGDHDG) ACC","ARGX":"Argenx SE","LU1059921491.USD":"NORDEA 1 GLOBAL STABLE EQUITY \"HB\" (USDHDG) ACC","BK4588":"碎股","LU1244550221.USD":"FRANKLIN GLOBAL MULTI-ASSET  INCOME \"A\" (USDHEDGED) INC (M)","BK4568":"美国抗疫概念","BK4198":"医疗保健用品","LU1074936037.SGD":"JPMorgan Funds - US Value A (acc) SGD","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","LU2133065610.SGD":"JPMorgan Investment Funds - Global Dividend A (mth) SGD","LU0795875169.SGD":"JPMorgan Investment Funds - Global Income A (div) SGD-H","LU0345770993.USD":"NINETY ONE GSF GLOBAL STRATEGIC EQUITY \"A\" (USD) INC","LU1244550494.USD":"FRANKLIN GLOBAL MULTI-ASSET INCOME \"A\" (USDHEDGED) ACC","BK4505":"高瓴资本持仓","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4581":"高盛持仓","FULC":"Fulcrum Therapeutics","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","LU1929549753.HKD":"FRANKLIN INCOME \"A\" (HKD) INC","BK4504":"桥水持仓","LU0889566641.SGD":"FTSF - Templeton Shariah Global Equity A Acc SGD","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","LU1032955483.USD":"NORDEA 1 STABLE RETURN \"HB\" (USDHDG) ACC"},"translate_title":"JNJ寻求FDA首次批准自身免疫性疾病药物Nipocalimab","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SOC":1,"ARGX":1,"BVS":1,"JNJ":1,"FULC":0.9},"content_text":"Johnson & Johnson JNJ 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.\nThe 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.\nPer 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.\ngMG 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.\nJNJ Stock Performance\nYear to date, J&J’s shares have moved up 4.8% compared with the industry’s 27.1% rise.\nImage Source: Zacks Investment Research\nCompetition in the gMG Space\nIf approved, nipocalimab will enter a competitive market for gMG treatments. The J&J drug would face stiff competition from Argenx’s ARGX Vyvgart/Vyvgart Hytrulo and Belgium-based UCB’s Rystiggo, both of which are also FcRn blockers and were approved last year in gMG indication.\nWhile 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).\nJNJ’s Nipocalimab Development\nJ&J is evaluating nipocalimab across multiple immunology and neuroscience indications in separate mid-stage to late-stage clinical studies.\nManagement 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.\nJNJ Zacks Rank\nJ&J currently carries a Zacks Rank #4 (Sell).\n\nJohnson & Johnson Price\n\nJohnson & Johnson price | Johnson & Johnson Quote\n\n \nOur Key Picks Among Biotech Stocks\nA couple of better-ranked stocks include Bioventus BVS and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn 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%.\nBVS’ 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.\nIn 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%.\nEarnings of Fulcrum Therapeutics beat estimates in each of the trailing four quarters. Fulcrum delivered an earnings surprise of 393.18%, on average.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nJohnson & Johnson (JNJ) : Free Stock Analysis Report\nargenex SE (ARGX) : Free Stock Analysis Report\nFulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report\nBioventus Inc. (BVS) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.26.4","shortVersion":"4.26.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2463767162"}