SELLAS (SLS) Rises on FDA Fast Track Tag to Leukemia Candidate

Zacks01-11

SELLAS Life Sciences Group, Inc. SLS announced that the FDA has granted a Fast Track designation to its novel and highly selective CDK9 inhibitor, SLS009, for the treatment of relapsed/refractory (r/r...

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SLS announced that the FDA has granted a Fast Track designation to its novel and highly selective CDK9 inhibitor, SLS009, for the treatment of relapsed/refractory (r/r...</p>\n\n<a href=\"https://finance.yahoo.com/news/sellas-sls-rises-fda-fast-163000372.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>SELLAS (SLS) Rises on FDA Fast Track Tag to Leukemia Candidate</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\">\nSELLAS (SLS) Rises on FDA Fast Track Tag to Leukemia Candidate\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-01-11 00:30 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/sellas-sls-rises-fda-fast-163000372.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>SELLAS Life Sciences Group, Inc. SLS announced that the FDA has granted a Fast Track designation to its novel and highly selective CDK9 inhibitor, SLS009, for the treatment of relapsed/refractory (r/r...</p>\n\n<a href=\"https://finance.yahoo.com/news/sellas-sls-rises-fda-fast-163000372.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":"SRPT","symbol_name":"Sarepta Therapeutics","start_time":0,"source_url":"https://finance.yahoo.com/news/sellas-sls-rises-fda-fast-163000372.html","article_id":"2402948774","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/OqpBwYnlazUrZRs4ONCSFw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/3ecb7b8f4826ee26a884371aa5efe958"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2402948774","pubTimestamp":1704904200,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"The Fast Track designation from the FDA facilitates rapid development and expedites the review of candidates that are being developed to treat serious conditions and have the potential to address unmet medical needs.The Fast Track tag is likely to expedite the development path for SLS009 and help in a faster regulatory filing for the candidate in r/r AML in the United States.The FDA has already granted an Orphan Drug designation to SLS009 for r/r AML.Shares of SELLAS have plunged 79.2% in the past year compared with the industry’s decline of 11.4%.Concurrently, the company announced initial positive top-line data from the 45 mg  dose cohort of a phase IIa study on SLS009. A total of nine patients were enrolled in the 45 mg cohort.In the study, treatment with the 45mg dose of SLS009 in combination with aza/ven demonstrated anti-leukemic effects with a favorable safety profile in AML patients who are resistant to venetoclax combination therapies.In the past 60 days, estimates for Sarepta","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"SRPT":"Sarepta Therapeutics","PBYI":"Puma Biotechnology Inc","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","BK4139":"生物科技","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","FRLN":"Freeline Therapeutics Holdings plc","BK4161":"工业机械","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","SLS":"SELLAS Life Sciences Group Inc.","FAST":"快扣","CR":"crane","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","BK4585":"ETF&股票定投概念"},"translate_title":"SELLAS（SLS）在FDA快速通道标签上上升为白血病候选","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CR":1,"FAST":1,"FRLN":1,"PBYI":1,"SLS":1,"SRPT":1},"content_text":"SELLAS Life Sciences Group, Inc. SLS announced that the FDA has granted a Fast Track designation to its novel and highly selective CDK9 inhibitor, SLS009, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). Shares rose 4.1% on Jan 9 following the announcement.\nThe Fast Track designation from the FDA facilitates rapid development and expedites the review of candidates that are being developed to treat serious conditions and have the potential to address unmet medical needs.\nThe Fast Track tag is likely to expedite the development path for SLS009 and help in a faster regulatory filing for the candidate in r/r AML in the United States.\nThe FDA has already granted an Orphan Drug designation to SLS009 for r/r AML.\nShares of SELLAS have plunged 79.2% in the past year compared with the industry’s decline of 11.4%.\nImage Source: Zacks Investment Research\nConcurrently, the company announced initial positive top-line data from the 45 mg (safety) dose cohort of a phase IIa study on SLS009. A total of nine patients were enrolled in the 45 mg cohort.\nThe phase IIa study is evaluating the safety, tolerability and efficacy of two dose levels of SLS009 — 45 mg and 60 mg — in combination with AbbVie’s Venclexta (venetoclax) and azacytidine (aza/ven) for treating r/r AML.\nIn the study, treatment with the 45mg dose of SLS009 in combination with aza/ven demonstrated anti-leukemic effects with a favorable safety profile in AML patients who are resistant to venetoclax combination therapies.\nOut of the nine patients, one patient died due to sepsis. A significant anti-leukemic effect was observed in 87.5% of the evaluable patients.\nThe first patient enrolled in the study achieved a complete response (CR) with full peripheral blood recovery. The median overall survival has not been reached yet.\nSELLAS also enrolled several patients who are in the ongoing 60 mg cohort of the above study.\nAdditional data from the fully enrolled 45 mg cohort and initial data from the 60 mg cohort are expected to be reported later in the first quarter of 2024.\nSLS009 is also being evaluated in a phase Ib/II study for the treatment of relapsed/refractory peripheral t-cell lymphomas (PTCL). The FDA granted a Fast Track Designation to SLS009 in relapsed/refractory PTCL.\nWe note that SELLAS currently does not have any approved product in its portfolio. Therefore, in the absence of a marketed product, the successful development of SLS009, along with other candidates, holds the key for the company.\nZacks Rank & Stocks to Consider\nSELLAS currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the healthcare sector are Sarepta Therapeutics, Inc. SRPT Freeline Therapeutics Holdings plc FRLN and Puma Biotechnology, Inc. PBYI, 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 Sarepta’s 2024 earnings per share have improved from 46 cents to $1.72. In the past year, shares of SRPT have lost 0.3%.\nSarepta beat estimates in each of the last four quarters. SRPT delivered a four-quarter earnings surprise of 48.67%, on average.\nIn the past 60 days, estimates for Freeline Therapeutics’ 2024 loss per share have narrowed from 35 cents to 15 cents. In the past year, shares of FRLN have declined 11.8%.\nEarnings of Freeline Therapeutics beat estimates in each of the last three quarters. FRLN delivered a four-quarter average earnings surprise of 67.17%.\nIn the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 2.8%.\nEarnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.\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\nSarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report\nPuma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report\nGalena Biopharma, Inc. (SLS) : Free Stock Analysis Report\nFreeline Therapeutics Holdings PLC Sponsored ADR (FRLN) : 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":"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":"4.29.3","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/2402948774"}