JAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer

Zacks11-22

Jazz Pharmaceuticals JAZZ announced that the FDA has granted accelerated approval to its intravenously administered drug zanidatamab for certain patients with biliary tract cancer (BTC). The drug will...

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The drug will...</p>\n\n<a href=\"https://finance.yahoo.com/news/jazz-secures-fda-approval-ziihera-170800441.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>JAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nJAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-22 01:08 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/jazz-secures-fda-approval-ziihera-170800441.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Jazz Pharmaceuticals JAZZ announced that the FDA has granted accelerated approval to its intravenously administered drug zanidatamab for certain patients with biliary tract cancer (BTC). The drug will...</p>\n\n<a href=\"https://finance.yahoo.com/news/jazz-secures-fda-approval-ziihera-170800441.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"CSTL","symbol_name":"Castle Biosciences, Inc.","start_time":0,"source_url":"https://finance.yahoo.com/news/jazz-secures-fda-approval-ziihera-170800441.html","article_id":"2485144543","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/B7EfA6ERTo_QO90H15uyXw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/9c1d11cd27737fac4805145de6e5eee0"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2485144543","pubTimestamp":1732208880,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Jazz Pharmaceuticals JAZZ announced that the FDA has granted accelerated approval to its intravenously administered drug zanidatamab for certain patients with biliary tract cancer . The drug will be marketed under the trade name Ziihera.With this nod, Ziihera gets approved for use in previously treated adult patients with unresectable or metastatic HER2-positive BTC. The approval also makes this drug the first dual HER2-targeted bispecific antibody and chemotherapy-free therapy for treating BTC in the country.The commercial launch of the drug is expected before this year’s end.The FDA’s approval is based on data from the phase IIb HERIZON-BTC-01 study on zanidatamab in the above indication. The study achieved its primary endpoint — patients who were treated with the drug achieved an objective response rate of 52%, with a median duration of response of 14.9 months.In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 13 cents. Estimat","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"CSTL":"Castle Biosciences, Inc.","BTC":"Grayscale Bitcoin Mini Trust","BK4532":"文艺复兴科技持仓","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","CTMX":"CytomX","BK4007":"制药","JAZZ":"爵士制药","BK4196":"保健护理服务","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4139":"生物科技","BK4533":"AQR资本管理(全球第二大对冲基金)","SPRO":"Spero Therapeutics Inc.","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD"},"translate_title":"JAZZ获得FDA批准Ziihera治疗胆道癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BTC":1,"CSTL":1,"CTMX":1,"JAZZ":1,"SPRO":0.9},"content_text":"Jazz Pharmaceuticals JAZZ announced that the FDA has granted accelerated approval to its intravenously administered drug zanidatamab for certain patients with biliary tract cancer (BTC). The drug will be marketed under the trade name Ziihera.\nWith this nod, Ziihera gets approved for use in previously treated adult patients with unresectable or metastatic HER2-positive BTC. The approval also makes this drug the first dual HER2-targeted bispecific antibody and chemotherapy-free therapy for treating BTC in the country.\nThe commercial launch of the drug is expected before this year’s end.\nThe FDA’s approval is based on data from the phase IIb HERIZON-BTC-01 study on zanidatamab in the above indication. The study achieved its primary endpoint — patients who were treated with the drug achieved an objective response rate of 52%, with a median duration of response of 14.9 months.\nJAZZ Stock Performance\nYear to date, shares of Jazz have lost 3.0% compared with the industry’s 10.9% decline.\nImage Source: Zacks Investment Research\nJAZZ’s Progress With Ziihera Development\nJazz is conducting the phase III HERIZON-BTC-302 study on Ziihera combined with standard-of-care (SoC) therapy in the first-line setting for patients with HER2-positive BTC compared with SoC alone. This study will also be used to convert the accelerated approval to a full one.\nApart from BTC, Jazz is also developing the drug in two late-stage studies in gastroesophageal adenocarcinoma (GEA) and metastatic breast cancer indications. Top-line data from the GEA study are expected in the second quarter of 2025. Management is also evaluating Ziihera in the phase II DiscovHER-Pan-206 pan-tumor study in HER2-positive solid tumors.\nJazz acquired exclusive rights to develop and market across Ziihera in all territories except Asia/Pacific (where the drug has been licensed to BeiGene) from Zymeworks in 2022.\nJAZZ’s Zacks Rank\nJAZZ currently carries a Zacks Rank #3 (Hold).\n\nJazz Pharmaceuticals PLC Price\n\nJazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote\n\nKey Picks Among Biotech Stocks\nSome better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, 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 Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 33.8%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.\nIn the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 13 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 46 cents. Year to date, shares of CytomX Therapeutics have lost 42.4%.\nCytomX Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 115.70%.\nIn the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.31. Estimates for 2025 loss per share have narrowed from $1.54 to $1.16. Year to date, shares of Spero Therapeutics have lost 21.1%.\nSpero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.\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\nJazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report\nCytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report\nSpero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"Product Release","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":"4.29.3","shortVersion":"4.29.3","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/2485144543"}