Roche (RHHBY) Receives FDA Nod for Vabysmo Prefilled Syringe

Zacks07-05

Roche RHHBY obtained FDA approval for a single-dose prefilled syringe (PFS) of ophthalmology drug Vabysmo (faricimab) for three main causes of vision loss. The PFS has been approved for use in the ...

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It has been designed to simplify administration.Vabysmo is the first and only bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2  and vascular endothelial growth factor-A . Vabysmo has put a stellar performance.The drug is already approved in several countries for the aforementioned indications, and review by other health authorities across the globe is ongoing.Roche’s shares have lost 5.8% year to date against the industry’s grow","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0058720904.USD":"联博国际健康护理基金A","LU2362540622.SGD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (SGDHDG) ACC","BK4087":"商业印刷","REGN":"再生元制药公司","03165":"华夏欧优股对冲","ALXO":"ALX Oncology Holdings","LU0053666078.USD":"摩根大通基金-美国股票A（离岸）美元","BK4585":"ETF&股票定投概念","RHHBY":"罗氏控股","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","BK4139":"生物科技","LU2362541513.USD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (USD) ACC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4007":"制药","BK4211":"区域性银行","LU2362541273.HKD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (HKD) ACC","LU1917777945.USD":"安联专题基金Cl AT Acc","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","BK4195":"互助储蓄与抵押信贷金融服务","BK4121":"生命科学工具和服务","CHMP":"冠军工业","CGEN":"Compugen医疗","BK4588":"碎股","LU2106854487.HKD":"ALLIANZ THEMATICA \"AMG\" (HKD) INC","LU0882574055.USD":"富达全球健康医疗A ACC","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","PFS":"Provident Financial Services Inc","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)"},"translate_title":"罗氏(RHHBY)的Vabysmo预充式注射器获得FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RHHBY":1,"REGN":1,"PFS":1,"CHMP":1,"CGEN":1,"ALXO":0.9,"03165":0.6},"content_text":"Roche RHHBY obtained FDA approval for a single-dose prefilled syringe (PFS) of ophthalmology drug Vabysmo (faricimab) for three main causes of vision loss.\nThe PFS has been approved for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).\nThe PFS delivers the same drug as the currently available Vabysmo vials in an alternative, ready-to-use format. It has been designed to simplify administration.\nVabysmo is the first and only bispecific antibody approved for the eye.  It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).  Vabysmo has put a stellar performance.\nThe drug is already approved in several countries for the aforementioned indications, and review by other health authorities across the globe is ongoing.\nRoche’s shares have lost 5.8% year to date against the industry’s growth of 19.7%.\nImage Source: Zacks Investment Research\nThe European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended a label expansion of Vabysmo for the treatment of visual impairment due to macular edema secondary to RVO.\nThe European Commission is expected to give a final decision shortly.\nRoche’s ophthalmology portfolio also comprises Susvimo and Lucentis. Susvimo (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant was approved by the FDA in 2021.\nApproval of new drugs and label expansion of the existing ones should bode well for Roche. Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel Roche’s top line as the company looks to fill up the dent in revenues caused by a decline in COVID-19-related sales. Competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin continues to hurt sales.\nSales of Regeneron’s REGN blockbuster ophthalmology drug Eylea have been under pressure due to competition from Vabysmo. \nTo counter the decline in Eylea sales, Regeneron developed a higher dose of the drug. The initial uptake of Eylea HD is encouraging as Eylea patients transition to the higher dose.\nZacks Rank & Stocks to Consider\nRoche currently carries a Zacks Rank #3 (Hold).\nA couple of better-ranked stocks in the healthcare sector are ALX Oncology Holdings ALXO and Compugen CGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nIn the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73.\nALX Oncology beat on earnings in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.\nIn the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents.\nCGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%. \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\nRoche Holding AG (RHHBY) : Free Stock Analysis Report\nCompugen Ltd. (CGEN) : Free Stock Analysis Report\nALX Oncology Holdings Inc. (ALXO) : 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":"4.28.3","shortVersion":"4.28.3","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/2449929540"}