{"id":48536,"date":"2025-11-18T14:42:48","date_gmt":"2025-11-18T06:42:48","guid":{"rendered":"https:\/\/flcube.com\/?p=48536"},"modified":"2025-11-18T14:42:50","modified_gmt":"2025-11-18T06:42:50","slug":"bms-and-jj-halt-phase-iii-milvexian-anticoagulant-trial-for-acute-coronary-syndrome-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=48536","title":{"rendered":"BMS and J&amp;J Halt Phase\u202fIII Milvexian Anticoagulant Trial for Acute Coronary Syndrome Patients"},"content":{"rendered":"\n<p><strong>Bristol\u2011Myers Squibb (BMS, <a href=\"https:\/\/www.google.com\/finance\/quote\/BMY:NYSE\">NYSE: BMY<\/a>)<\/strong> and <strong>Johnson &amp; Johnson (J&amp;J, <a href=\"https:\/\/www.google.com\/finance\/quote\/JNJ:NYSE\">NYSE: JNJ<\/a>)<\/strong> announced the <strong>premature termination<\/strong> of their joint Phase\u202fIII study of the <strong>Factor\u202fXIIa inhibitor milvexian<\/strong> in patients who have recently suffered an <strong>acute coronary syndrome (ACS)<\/strong> event.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-trial-overview\">Trial Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Design<\/strong><\/td><td>Randomized, double\u2011blind, parallel\u2011group<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>~16,000 subjects with recent ACS<\/td><\/tr><tr><td><strong>Intervention<\/strong><\/td><td>Milvexian (investigational) vs. standard antiplatelet therapy<\/td><\/tr><tr><td><strong>Primary endpoint<\/strong><\/td><td>Time to first <strong>major adverse cardiovascular event (MACE)<\/strong><\/td><\/tr><tr><td><strong>Planned completion<\/strong><\/td><td>End of 2026<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>Stopped early for <strong>futility<\/strong> after interim analysis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-interim-findings\">Interim Findings<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Data Monitoring Committee (DMC)<\/strong> performed a pre\u2011planned interim review and concluded that the probability of achieving the primary efficacy endpoint was <strong>insufficient<\/strong>.<\/li>\n\n\n\n<li><strong>Safety<\/strong>: No new safety signals emerged; the adverse\u2011event profile of milvexian remained comparable to control.<\/li>\n\n\n\n<li><strong>Decision<\/strong>: BMS and J&amp;J mutually agreed to discontinue enrollment and follow\u2011up for this indication.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-ongoing-milvexian-programs\">Ongoing Milvexian Programs<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Indication<\/th><th>Phase<\/th><th>Status<\/th><\/tr><\/thead><tbody><tr><td><strong>Atrial fibrillation (AFib)<\/strong><\/td><td>Phase\u202fIII<\/td><td>Continuing<\/td><\/tr><tr><td><strong>Secondary stroke prevention (SSP)<\/strong><\/td><td>Phase\u202fIII<\/td><td>Continuing<\/td><\/tr><tr><td><strong>ACS (current trial)<\/strong><\/td><td>Phase\u202fIII<\/td><td>Terminated for futility<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The partners will redirect resources to these programs, where early data have shown a more favorable risk\u2011benefit balance.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-market-impact\">Market Impact<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Revenue outlook<\/strong> \u2013 The halted ACS program represented an estimated <strong>$1.2\u202fbillion<\/strong> peak\u2011year revenue opportunity for both companies.<\/li>\n\n\n\n<li><strong>Strategic implications<\/strong> \u2013 The termination underscores the high bar for novel anticoagulants in the crowded ACS space, where existing antiplatelet agents already demonstrate strong efficacy.<\/li>\n\n\n\n<li><strong>Share reaction<\/strong> \u2013 BMS shares were down <strong>1.3\u202f%<\/strong> in pre\u2011market trading; J&amp;J shares slipped <strong>0.9\u202f%<\/strong>.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This brief contains forward\u2011looking statements regarding the termination of the milvexian ACS trial, ongoing studies, and potential market effects. Actual results may differ due to clinical outcomes, regulatory actions, competitive dynamics, and other risk factors.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bristol\u2011Myers Squibb (BMS, NYSE: BMY) and Johnson &amp; Johnson (J&amp;J, NYSE: JNJ) announced the premature&#8230;<\/p>\n","protected":false},"author":1,"featured_media":48540,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[429,428,17,69,150,149,849,858],"class_list":["post-48536","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-clinical-trial-results","tag-cvd","tag-jj","tag-johnson-johnson","tag-nyse-bmy","tag-nyse-jnj"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BMS and J&amp;J Halt Phase\u202fIII Milvexian Anticoagulant Trial for Acute Coronary Syndrome Patients - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bristol\u2011Myers Squibb (BMS, NYSE: BMY) and Johnson &amp; Johnson (J&amp;J, NYSE: JNJ) announced the premature termination of their joint Phase\u202fIII study of the Factor\u202fXIIa inhibitor milvexian in patients who have recently suffered an acute coronary syndrome (ACS) event.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=48536\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BMS and J&amp;J Halt Phase\u202fIII Milvexian Anticoagulant Trial for Acute Coronary Syndrome Patients\" \/>\n<meta property=\"og:description\" content=\"Bristol\u2011Myers Squibb (BMS, NYSE: BMY) and Johnson &amp; Johnson (J&amp;J, NYSE: JNJ) announced the premature termination of their joint Phase\u202fIII study of the Factor\u202fXIIa inhibitor milvexian in patients who have recently suffered an acute coronary syndrome (ACS) event.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=48536\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-18T06:42:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-18T06:42:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1803.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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