FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria

Zacks11-19

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic ...

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The FDA’s decision on the sBLA is expected on April 18, 2025.The FDA had issued a complete response letter  for the first sBLA seeking approval of Dupixent for CSU in October last year for want of more data.Sanofi’s stock has declined 3.5% so far this year against an increase of 3.4% for the industry.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","PFE":"辉瑞","BK4007":"制药","LU2362541273.HKD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (HKD) ACC","BK4566":"资本集团","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","BK4139":"生物科技","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","BK4578":"CAR-T","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","BK4121":"生命科学工具和服务","LU0823416689.USD":"BNP PARIBAS HEALTH CARE INNOVATORS \"C\" (USD) ACC","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","LU0234570918.USD":"高盛全球核心股票组合Acc Close","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","LU2106854487.HKD":"ALLIANZ THEMATICA \"AMG\" (HKD) INC","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","GILD":"吉利德科学","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","IE00BFXG1179.USD":"BNY MELLON U.S. EQUITY INCOME \"B\" (USD) INC","LU2362540622.SGD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (SGDHDG) ACC","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","SG9999002224.SGD":"Allianz Global High Payout SGD","SNY":"赛诺菲安万特","LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","BK4585":"ETF&股票定投概念","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","REGN":"再生元制药公司","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","BK4530":"医药外包概念","BK4583":"猴痘概念","BK4532":"文艺复兴科技持仓","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","BK4592":"伊斯兰概念","CRL":"查尔斯河","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","BK4534":"瑞士信贷持仓","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD"},"translate_title":"FDA接受SNY和REGN的Dupixent重新提交的荨麻疹sBLA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SNY":1,"GILD":1,"CRL":1,"REGN":1,"PFE":0.9},"content_text":"Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).\nThe sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.\nThe FDA had issued a complete response letter (CRL) for the first sBLA seeking approval of Dupixent for CSU in October last year for want of more data.\nSanofi’s stock has declined 3.5% so far this year against an increase of 3.4% for the industry.\nImage Source: Zacks Investment Research\nCSU is an inflammatory skin condition, primarily occurring due to type 2 inflammation. This causes sudden and debilitating hives and swelling on the skin, which is mostly inadequately controlled by antihistamine treatment. The second sBLA for Dupixent in CSU was based on new data from the pivotal phase III study called LIBERTY-CUPID Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Data from Study C confirmed that Dupixent significantly reduced itch and hive activity. The original sBLA was supported by positive data from two phase III studies, LIBERTY-CUPID Studies A and B.\nDupixent is already approved for the CSU indication in Japan while it is under review in the EU.\nDupixent – Key Top-Line Driver for SNY, REGN\nDupixent is now approved in several countries, including the United States and EU, for six type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.\nDupixent is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug.\nDupixent is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first nine months of 2024, Dupixent generated global product sales of $€9.6 billion, which were recorded by Sanofi, representing growth of 25.9% at a constant exchange rate. Sanofi expects Dupixent to achieve more than €13 billion in sales in 2024.\nFor Regeneron, Dupixent generated collaboration revenues of $3.32 billion in the first nine months of 2024, up 18.2% year over year.\nSNY’s Zacks Rank and Stocks to Consider\nSanofi currently has a Zacks Rank #3 (Hold).\n\nSanofi Price and Consensus\n\nSanofi price-consensus-chart | Sanofi Quote\n\nSome top-ranked drug/biotech companies are Gilead GILD and Pfizer PFE, both with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nEstimates for Gilead’s 2024 earnings have risen from $3.77 to $4.28 per share over the past 60 days. For 2025, earnings estimates have risen from $7.27 to $7.40 per share over the same timeframe. Year to date, Gilead’s stock has risen 9.2%.\nGilead beat estimates in three of the last four reported quarters, while missing in one, delivering an average earnings surprise of 15.46%.\nThe Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.66 to $2.88 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.86 per share to $2.92 per share. Pfizer’s shares have declined 13.9% year to date.\nPfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 74.50%. \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\nRegeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report\nSanofi (SNY) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : 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":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"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":"4.29.2","shortVersion":"4.29.2","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/2484984151"}