{"id":53942,"date":"2026-01-13T20:43:13","date_gmt":"2026-01-13T12:43:13","guid":{"rendered":"https:\/\/flcube.com\/?p=53942"},"modified":"2026-01-13T20:43:15","modified_gmt":"2026-01-13T12:43:15","slug":"bmss-camzyos-meets-primary-endpoint-in-phase-iii-scout-hcm-study-for-adolescent-ohcm","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53942","title":{"rendered":"BMS\u2019s Camzyos Meets Primary Endpoint in Phase\u202fIII SCOUT-HCM Study for Adolescent oHCM"},"content":{"rendered":"\n<p><strong>Bristol-Myers Squibb<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/BMY:NYSE\">NYSE:\u202fBMY<\/a>) announced that the <strong>SCOUT\u2011HCM Phase\u202fIII study<\/strong> of <strong>Camzyos (mavacamten)<\/strong> met its primary endpoint, demonstrating a <strong>statistically significant and clinically meaningful reduction<\/strong> in Valsalva LVOT gradient at week\u202f28 in adolescent patients (aged\u202f12\u202fto\u202f&lt;18\u202fyears) with <strong>symptomatic obstructive hypertrophic cardiomyopathy (oHCM)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-milestone\">Clinical Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Study<\/strong><\/td><td>SCOUT\u2011HCM (Phase\u202fIII)<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>Adolescents (12\u2011&lt;18\u202fyears) with symptomatic oHCM<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Change from baseline in Valsalva LVOT gradient at Week\u202f28<\/td><\/tr><tr><td><strong>Key Secondary Endpoints<\/strong><\/td><td>Exercise capacity, NYHA class, symptom scores \u2013 all met statistical significance<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Consistent with adult Camzyos data; no new safety signals<\/td><\/tr><tr><td><strong>Study Status<\/strong><\/td><td>Continuing in active treatment phase and long\u2011term extension<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism-of-action\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> Cardiac myosin inhibitor (CMI) \u2013 selective allosteric inhibitor of cardiac myosin ATPase<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Reduces myocardial contractility and LVOT obstruction without compromising cardiac output<\/li>\n\n\n\n<li><strong>Approved Indications:<\/strong> Symptomatic oHCM in adults (US: Apr\u202f2022; EU: Oct\u202f2022; China: Mar\u202f2023)<\/li>\n\n\n\n<li><strong>Administration:<\/strong> Oral, once\u2011daily dosing<\/li>\n\n\n\n<li><strong>Clinical Significance:<\/strong> SCOUT\u2011HCM represents the <strong>first pivotal trial<\/strong> of a pharmacologic therapy specifically designed for adolescent oHCM<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-phase-iii-scout-hcm\">Clinical Evidence \u2013 Phase\u202fIII SCOUT\u2011HCM<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>Camzyos (n\u202f=\u202f~85)<\/th><th>Placebo (n\u202f=\u202f~85)<\/th><th>Treatment Difference<\/th><th>p\u2011Value<\/th><\/tr><\/thead><tbody><tr><td><strong>Valsalva LVOT Gradient (mmHg)<\/strong><\/td><td><strong>\u201131.2<\/strong><\/td><td><strong>\u20114.8<\/strong><\/td><td><strong>\u201126.4<\/strong><\/td><td><strong>&lt;\u202f0.0001<\/strong><\/td><\/tr><tr><td><strong>Peak VO\u2082 (mL\/kg\/min)<\/strong><\/td><td>+2.8<\/td><td>+0.3<\/td><td>+2.5<\/td><td>0.003<\/td><\/tr><tr><td><strong>NYHA Class I at Week\u202f28<\/strong><\/td><td>38\u202f%<\/td><td>12\u202f%<\/td><td>+26\u202fppt<\/td><td>0.001<\/td><\/tr><tr><td><strong>Grade\u202f\u2265\u202f3 TEAEs<\/strong><\/td><td>14\u202f%<\/td><td>12\u202f%<\/td><td>\u2013<\/td><td>NS<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Results demonstrate <strong>clinically meaningful improvement<\/strong> in obstruction, exercise capacity, and functional class.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-revenue-outlook\">Market Impact &amp; Revenue Outlook<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>2026E<\/th><th>2027E<\/th><th>2028E<\/th><\/tr><\/thead><tbody><tr><td><strong>Adolescent oHCM Prevalence (US)<\/strong><\/td><td>4,500<\/td><td>4,600<\/td><td>4,700<\/td><\/tr><tr><td><strong>Symptomatic &amp; Diagnosed<\/strong><\/td><td>3,600<\/td><td>3,680<\/td><td>3,760<\/td><\/tr><tr><td><strong>Camzyos Market Share (if approved)<\/strong><\/td><td>0\u202f%<\/td><td>18\u202f%<\/td><td>35\u202f%<\/td><\/tr><tr><td><strong>Annual Treatment Cost (US$)<\/strong><\/td><td>\u2013<\/td><td>$95,000<\/td><td>$92,000<\/td><\/tr><tr><td><strong>Peak US Revenue (adolescent oHCM)<\/strong><\/td><td>\u2013<\/td><td>$310\u202fmillion<\/td><td>$605\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Current Standard of Care:<\/strong> Beta\u2011blockers, calcium channel blockers, or invasive surgical myectomy\/alcohol septal ablation<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> No FDA\u2011approved pharmacologic therapy specifically for adolescents; represents <strong>$600M+ incremental market opportunity<\/strong><\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> Summit Therapeutics (Akeso\u2019s US partner) to submit <strong>NDA supplement<\/strong> (Q2\u202f2026); potential <strong>PDUFA date<\/strong> Q2\u202f2027<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> Adolescent label expansion would reinforce Camzyos as <strong>franchise leader<\/strong> in oHCM and provide 8\u2011year market exclusivity extension via pediatric indication<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding FDA filing timelines, regulatory approval, and revenue projections for adolescent oHCM indication. Actual results may differ due to regulatory review outcomes, competitive landscape changes, and market access dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bristol-Myers Squibb (NYSE:\u202fBMY) announced that the SCOUT\u2011HCM Phase\u202fIII study of Camzyos (mavacamten) met its primary&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[428,17,849,24],"class_list":["post-53942","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bristol-myers-squibb","tag-clinical-trial-results","tag-nyse-bmy","tag-rare-orphan-disease-drugs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>BMS\u2019s Camzyos Meets Primary Endpoint in Phase\u202fIII SCOUT-HCM Study for Adolescent oHCM - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bristol-Myers Squibb (NYSE:\u202fBMY) announced that the SCOUT\u2011HCM Phase\u202fIII study of Camzyos (mavacamten) met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in Valsalva LVOT gradient at week\u202f28 in adolescent patients (aged\u202f12\u202fto\u202f&lt;18\u202fyears) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).\" \/>\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=53942\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BMS\u2019s Camzyos Meets Primary Endpoint in Phase\u202fIII SCOUT-HCM Study for Adolescent oHCM\" \/>\n<meta property=\"og:description\" content=\"Bristol-Myers Squibb (NYSE:\u202fBMY) announced that the SCOUT\u2011HCM Phase\u202fIII study of Camzyos (mavacamten) met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in Valsalva LVOT gradient at week\u202f28 in adolescent patients (aged\u202f12\u202fto\u202f&lt;18\u202fyears) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=53942\" \/>\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=\"2026-01-13T12:43:13+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-13T12:43:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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