Biotech Stock Roundup: SAGE, INCY Suffer Setbacks, JAZZ Wins Oncology Drug Approval & More

Zacks01:13

The focus shifts back to regualr pipleine updates in the biotech sector with the end of the third-quarter earnings season. Among these, Sage Therapeutics, Inc. SAGE and Incyte INCY were in focus this...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2485445105?lang=en_US&edition=fundamental","thumbnail":"https://s.yimg.com/uu/api/res/1.2/1H9NqoSNLfLtMd2fyMlfBA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/9883d206905e7516b2353476e213e60c","is_english":true,"pubTime":"2024-11-22 01:13","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2485445105","market":"us","top_or_hot":-1,"title":"Biotech Stock Roundup: SAGE, INCY Suffer Setbacks, JAZZ Wins Oncology Drug Approval & More","media":"Zacks","content":"<div>\n<p>The focus shifts back to regualr pipleine updates in the biotech sector with the end of the third-quarter earnings season. Among these, Sage Therapeutics, Inc. SAGE  and Incyte INCY were in focus this...</p>\n\n<a href=\"https://finance.yahoo.com/news/biotech-stock-roundup-sage-incy-171300122.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>Biotech Stock Roundup: SAGE, INCY Suffer Setbacks, JAZZ Wins Oncology Drug Approval & More</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\">\nBiotech Stock Roundup: SAGE, INCY Suffer Setbacks, JAZZ Wins Oncology Drug Approval & More\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-22 01:13 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/biotech-stock-roundup-sage-incy-171300122.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>The focus shifts back to regualr pipleine updates in the biotech sector with the end of the third-quarter earnings season. Among these, Sage Therapeutics, Inc. SAGE  and Incyte INCY were in focus this...</p>\n\n<a href=\"https://finance.yahoo.com/news/biotech-stock-roundup-sage-incy-171300122.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":"SG9999001176.USD","symbol_name":"United Global Healthcare Acc USD","start_time":0,"source_url":"https://finance.yahoo.com/news/biotech-stock-roundup-sage-incy-171300122.html","article_id":"2485445105","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/1H9NqoSNLfLtMd2fyMlfBA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/9883d206905e7516b2353476e213e60c"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2485445105","pubTimestamp":1732209180,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"The focus shifts back to regualr pipleine updates in the biotech sector with the end of the third-quarter earnings season. Among these, Sage Therapeutics, Inc. SAGE and Incyte INCY were in focus this week as investors were disappointed with study failures.Sage Therapeutics announced disppointing top-line results from the mid-stage study on dalzanemdor . The phase II DIMENSION Study was a 12-week, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor in participants with cognitive impairment  associated with Huntington’s Disease . A total of 189 participants were randomized.However, the study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Symbol Digit Modalities Test , a measure of cognitive function, at day 84, the primary endpoint.SAGE will also discontinue the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.PYX-201 achieved a confir","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"SG9999001176.USD":"United Global Healthcare Acc USD","LU0203345920.USD":"SCHRODER ISF QEP GLB ACT. VL \"A\" (USD) ACC","SG9999014542.SGD":"United Income Focus Trust Acc SGD","SAGE":"Sage Therapeutics","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU0211331839.USD":"FRANKLIN MUTUAL GLB DISCOVERY \"A\" (USD) ACC","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","LU1917777945.USD":"安联专题基金Cl AT Acc","INCY":"因塞特医疗","BK4585":"ETF&股票定投概念","LU2112291526.USD":"BGF WORLD HEALTHSCIENCE \"A4\" (USD) INC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","BK4533":"AQR资本管理(全球第二大对冲基金)","LU1066051811.HKD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (HKD) INC","LU2461242641.AUD":"WELLINGTON US QUALITY GROWTH \"A\" (AUDHDG) ACC","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU1941712348.USD":"ALLIANZ PET AND ANIMAL WELLBEING \"AT\" (USD) ACC","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","SG9999002224.SGD":"Allianz Global High Payout SGD","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","BTC":"Grayscale Bitcoin Mini Trust","SG9999002232.USD":"Allianz Global High Payout USD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","CI":"信诺保险","BK4559":"巴菲特持仓","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4588":"碎股","PYXS":"Pyxis Oncology, Inc.","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","SG9999014559.SGD":"United Income Focus Trust Dis SGD","LU1989772923.USD":"CPR Invest - Climate Action A2 Acc USD-H","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU0070302665.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) ACC","LU0238689110.USD":"贝莱德环球动力股票基金","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","JAZZ":"爵士制药","LU1059921491.USD":"NORDEA 1 GLOBAL STABLE EQUITY \"HB\" (USDHDG) ACC","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","LU0965509283.SGD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (SGDHDG) INC","LU2361045086.USD":"WELLINGTON US QUALITY GROWTH \"A\" (USD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0203347892.USD":"SCHRODER ISF QEP GLOBAL ACTIVE VALLUE \"A\" (USD)  INC AV","LU0985320562.USD":"NORDEA 1 GLOBAL STARS EQUITY \"BP\" (USD) ACC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU1116320737.USD":"BGF SYSTEMATIC GLOBAL ENHANCED EQUITY YIELD \"A6\" (USD) INC","MRK":"默沙东"},"translate_title":"生物科技股综述：SAGE、INCY遭受挫折、JAZZ赢得肿瘤药物批准等","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"JAZZ":1,"BTC":1,"CI":1,"INCY":1,"SAGE":1,"PYXS":1,"MRK":0.6},"content_text":"The focus shifts back to regualr pipleine updates in the biotech sector with the end of the third-quarter earnings season. Among these, Sage Therapeutics, Inc. SAGE  and Incyte INCY were in focus this week as investors were disappointed with study failures.\nRecap of the Week’s Most Important Stories:\nSAGE Suffers Setback\nSage Therapeutics  announced disppointing top-line results from the mid-stage study on dalzanemdor (SAGE-718). The phase II DIMENSION Study was a 12-week, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor in participants with cognitive impairment (CI) associated with Huntington’s Disease (“HD”). A total of 189 participants were randomized.\nHowever, the study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Symbol Digit Modalities Test (“SDMT”), a measure of cognitive function, at day 84, the primary endpoint.\nIn addition, analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Consequently, SAGE does not plan further development of dalzanemdor.\nSAGE will also discontinue the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.\nEarlier, LIGHTWAVE study to evaluate the effects of dalzanemdor in participants with mild cognitive impairment or mild dementia due to Alzheimer’s Disease (“AD”) also failed to meet its primary endpoint. SAGE then decided to stop the development of the candidate in AD.\nSage Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nIncyte Pauses Enrollment in CSU Study\nIncyte suffered a setback in its ongoing mid-stage study on MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).\nIncyte announced that it would pause enrollment in the ongoing phase II study of MRGPRX2 in CSU due to certain in vivo preclinical toxicology findings. The data was also shared with the FDA. The company is now working closely with the FDA to determine the next steps.\nAdditionally, data from the phase II study evaluating MRGPRX4 in cholestatic pruritus does not support further development.\nMeanwhile, enrollment in the other INCB000262 proof-of-concept studies is complete. Data from these studies should help support INCY’s future development and guide the potential growth of backup molecules.\nShares of INCY plunged on this setback.\nPyxis Reports Phase I Data\nPyxis Oncology, Inc. PYXS announced positive preliminary data from the ongoing phase I clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. Significant clinical responses were observed in patients with head and neck squamous cell carcinoma (HNSCC).\nPYX-201 achieved a confirmed 50% ORR by RECIST 1.1, including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients. The positive data supports PYXS’ plans to launch monotherapy expansion studies in the first quarter of 2025.\nPyxis also announced that it has entered into a clinical trial collaboration agreement with Merck.\nPer the terms of the deal, Pyxis Oncology will sponsor a study of PYX-201 in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with first-line and second-line HNSCC, HR+/HER2 breast cancer, and triple-negative breast cancer and sarcoma. Dosing is expected to begin in the first quarter of 2025.\nJAZZ Wins Drug Approval\nJazz Pharmaceuticals plc JAZZ announced that the FDA has granted accelerated approval to Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use to treat adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.\nThe accelerated approval was granted based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by an independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.\nThe late-stage HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.\nZanidatamab is also being evaluated in a number of additional tumor types, including phase III studies in gastroesophageal adenocarcinomas and metastatic breast cancer.\nPerformance\nThe Nasdaq Biotechnology Index has declined 5.99% in the past five trading sessions and Moderna’s shares have lost 12.34%. In the past six months, shares of MRNA have lost 73.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: NVAX Q3 Results, SNDX Down on AML Data, RNA Surges on Study Data)\nImage Source: Zacks Investment Research\nWhat's Next in Biotech?\nStay tuned for more pipeline updates. \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\nIncyte Corporation (INCY) : Free Stock Analysis Report\nJazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report\nSage Therapeutics, Inc. (SAGE) : Free Stock Analysis Report\nPyxis Oncology, Inc. (PYXS) : 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":"4.29.2","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/2485445105"}