Cogent Biosciences Says Bezuclastinib Showed 'Rapid and Deep Clinical Benefit' in Advanced Systemic Mastocytosis Trial

MT Newswires Live

Dec 08

Cogent Biosciences (COGT) said Monday that results from its Apex trial evaluating bezuclastinib in patients with advanced systemic mastocytosis showed "rapid and deep clinical benefit."

The company said the drug candidate demonstrated an objective response rate of 57% and 80% per pure pathological response criteria. It added that more than 89% of patients treated with it had a more than a 50% reduction in bone marrow mast cells or clearance of aggregates.

A new drug application to the US Food and Drug Administration for bezuclastinib in advanced systemic mastocytosis will be submitted in H1 2026, the company said.

Cogent also said that based on "positive" results from Apex and its other trials, it is preparing for multiple commercial launches in H2 2026.

Price: 38.84, Change: +0.07, Percent Change: +0.18

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It added that more than 89% of patients treated with it had a more than a 50% reduction in bone marrow mast cells or clearance of aggregates.</p><p>A new drug application to the US Food and Drug Administration for bezuclastinib in advanced systemic mastocytosis will be submitted in H1 2026, the company said.</p><p>Cogent also said that based on \"positive\" results from Apex and its other trials, it is preparing for multiple commercial launches in H2 2026.</p><p>Price: 38.84, Change: +0.07, Percent Change: +0.18</p></body></html>","source":"mtnewswires_news","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>Cogent Biosciences Says Bezuclastinib Showed 'Rapid and Deep Clinical Benefit' in Advanced Systemic Mastocytosis Trial</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\">\nCogent Biosciences Says Bezuclastinib Showed 'Rapid and Deep Clinical Benefit' in Advanced Systemic Mastocytosis Trial\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2025-12-08 23:29</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/COGT\">Cogent Biosciences</a> (COGT) said Monday that results from its Apex trial evaluating bezuclastinib in patients with advanced systemic mastocytosis showed \"rapid and deep clinical benefit.\"</p><p>The company said the drug candidate demonstrated an objective response rate of 57% and 80% per pure pathological response criteria. It added that more than 89% of patients treated with it had a more than a 50% reduction in bone marrow mast cells or clearance of aggregates.</p><p>A new drug application to the US Food and Drug Administration for bezuclastinib in advanced systemic mastocytosis will be submitted in H1 2026, the company said.</p><p>Cogent also said that based on \"positive\" results from Apex and its other trials, it is preparing for multiple commercial launches in H2 2026.</p><p>Price: 38.84, Change: +0.07, Percent Change: +0.18</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"CCOI","symbol_name":"Cogent Communications Group","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2589354697","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2589354697","pubTimestamp":1765207787,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. 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