{"id":53944,"date":"2026-01-13T20:46:59","date_gmt":"2026-01-13T12:46:59","guid":{"rendered":"https:\/\/flcube.com\/?p=53944"},"modified":"2026-01-13T20:47:01","modified_gmt":"2026-01-13T12:47:01","slug":"bayer-ag-acquires-cardiac-amyloidosis-imaging-tracers-from-attralus-including-phase-iii-at-01-with-fda-breakthrough-designation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=53944","title":{"rendered":"Bayer AG Acquires Cardiac Amyloidosis Imaging Tracers from Attralus, Including Phase\u202fIII AT\u201101 with FDA Breakthrough Designation"},"content":{"rendered":"\n<p><strong>Bayer AG<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/BAYN:ETR\">ETR:\u202fBAYN<\/a>) announced an agreement with <strong>Attralus, Inc.<\/strong> to acquire two investigational molecular imaging tracers for cardiac amyloidosis diagnosis: <strong>AT\u201101 (124\u2011Iodine\u2011evuzamitide)<\/strong> and <strong>AT\u201105 (PAR\u2011Peptide + technetium\u201199m)<\/strong>, bolstering Bayer\u2019s precision cardiology portfolio with a first\u2011in\u2011class PET agent holding FDA Breakthrough Therapy Designation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-amp-deal-milestone\">Regulatory &amp; Deal 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>Companies<\/strong><\/td><td>Bayer AG (acquirer) and Attralus, Inc. (originator)<\/td><\/tr><tr><td><strong>Assets Acquired<\/strong><\/td><td>AT\u201101 (PET tracer) and AT\u201105 (SPECT tracer)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Cardiac amyloidosis diagnosis<\/td><\/tr><tr><td><strong>AT\u201101 Status<\/strong><\/td><td>Phase\u202fIII; FDA Breakthrough Therapy Designation (first for cardiac amyloidosis)<\/td><\/tr><tr><td><strong>AT\u201105 Status<\/strong><\/td><td>Phase\u202fI development<\/td><\/tr><tr><td><strong>Global Patient Pool<\/strong><\/td><td>~400,000 affected; majority underdiagnosed<\/td><\/tr><tr><td><strong>Deal Structure<\/strong><\/td><td>Undisclosed financial terms; technology transfer and development partnership<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-profile-amp-clinical-advancement\">Technology Profile &amp; Clinical Advancement<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Cardiac Amyloidosis:<\/strong> Rare, fatal heart disease characterized by amyloid fibril deposition; current diagnosis often delayed due to lack of specific, non\u2011invasive tools<\/li>\n\n\n\n<li><strong>AT\u201101:<\/strong><\/li>\n\n\n\n<li><strong>Pan\u2011amyloid PET imaging agent<\/strong> labeled with Iodine\u2011124<\/li>\n\n\n\n<li>Detects <strong>all systemic amyloidosis types<\/strong> (ATTR wild\u2011type\/hereditary, AL) in heart, kidneys, liver, and spleen<\/li>\n\n\n\n<li><strong>Non\u2011invasive, whole\u2011body imaging<\/strong> with high sensitivity\/specificity<\/li>\n\n\n\n<li><strong>Regulatory Advantage:<\/strong> BTD enables accelerated FDA review and enhanced engagement<\/li>\n\n\n\n<li><strong>AT\u201105:<\/strong><\/li>\n\n\n\n<li><strong>SPECT tracer<\/strong> using technetium\u201199m (widely available radioisotope)<\/li>\n\n\n\n<li>Provides <strong>alternative diagnostic option<\/strong> for centers without PET infrastructure<\/li>\n\n\n\n<li>Phase\u202fI safety and biodistribution studies ongoing<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-competitive-landscape\">Market Opportunity &amp; Competitive Landscape<\/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>Global Cardiac Amyloidosis Diagnoses<\/strong><\/td><td>45,000<\/td><td>55,000<\/td><td>70,000<\/td><\/tr><tr><td><strong>Estimated Imaging Market (USD)<\/strong><\/td><td>$280\u202fmillion<\/td><td>$360\u202fmillion<\/td><td>$450\u202fmillion<\/td><\/tr><tr><td><strong>PET vs. SPECT Share<\/strong><\/td><td>60\u202f% \/ 40\u202f%<\/td><td>65\u202f% \/ 35\u202f%<\/td><td>70\u202f% \/ 30\u202f%<\/td><\/tr><tr><td><strong>AT\u201101 Peak Market Share (if approved)<\/strong><\/td><td>0\u202f%<\/td><td>15\u202f%<\/td><td>28\u202f%<\/td><\/tr><tr><td><strong>Revenue Forecast (AT\u201101 only)<\/strong><\/td><td>\u2013<\/td><td>$32\u202fmillion<\/td><td>$88\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Environment:<\/strong><\/li>\n\n\n\n<li><strong>Siemens Healthineers<\/strong> and <strong>GE Healthcare<\/strong> dominate cardiac PET radiotracer distribution<\/li>\n\n\n\n<li><strong>Currently approved agents:<\/strong> No PET\/SPECT tracer specifically approved for cardiac amyloidosis; diagnosis relies on <strong>PYP scintigraphy<\/strong> (limited availability) and <strong>biopsy<\/strong> (invasive)<\/li>\n\n\n\n<li><strong>Bayer\u2019s Strategic Moat:<\/strong> AT\u201101\u2019s BTD and pan\u2011amyloid capability position Bayer as <strong>first\u2011mover<\/strong> in a blue\u2011ocean diagnostic segment<\/li>\n\n\n\n<li><strong>Synergies:<\/strong> Integrates with Bayer\u2019s <strong>Vericiguat<\/strong> (heart failure) and <strong>Asundexian<\/strong> (antithrombotic) cardiology pipeline for comprehensive amyloidosis patient management<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning-amp-next-steps\">Strategic Positioning &amp; Next Steps<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Development Path:<\/strong><\/li>\n\n\n\n<li>AT\u201101 Phase\u202fIII data expected <strong>Q4\u202f2026<\/strong>; NDA submission <strong>H1\u202f2027<\/strong><\/li>\n\n\n\n<li>AT\u201105 Phase\u202fI completion <strong>Q3\u202f2026<\/strong>; pivotal study initiation <strong>Q1\u202f2027<\/strong><\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Leverage Bayer\u2019s <strong>Berkeley, CA radiopharmacy<\/strong> for I\u2011124 production and global distribution<\/li>\n\n\n\n<li><strong>Commercial Readiness:<\/strong> Bayer\u2019s 300\u2011person US cardiology sales force to be trained on amyloidosis diagnostics; <strong>KOL engagement<\/strong> initiated at 50 heart failure centers<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory approval timelines, market penetration, and revenue projections for AT\u201101 and AT\u201105. Actual results may differ due to clinical trial outcomes, competitive responses, and radiopharmaceutical supply chain constraints.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bayer AG (ETR:\u202fBAYN) announced an agreement with Attralus, Inc. to acquire two investigational molecular imaging&#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":[7,10],"tags":[269,967],"class_list":["post-53944","post","type-post","status-publish","format-standard","hentry","category-company","category-deals","tag-bayer","tag-etr-bayn"],"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>Bayer AG Acquires Cardiac Amyloidosis Imaging Tracers from Attralus, Including Phase\u202fIII AT\u201101 with FDA Breakthrough Designation - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Bayer AG (ETR:\u202fBAYN) announced an agreement with Attralus, Inc. to acquire two investigational molecular imaging tracers for cardiac amyloidosis diagnosis: AT\u201101 (124\u2011Iodine\u2011evuzamitide) and AT\u201105 (PAR\u2011Peptide + technetium\u201199m), bolstering Bayer\u2019s precision cardiology portfolio with a first\u2011in\u2011class PET agent holding FDA Breakthrough Therapy Designation.\" \/>\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=53944\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bayer AG Acquires Cardiac Amyloidosis Imaging Tracers from Attralus, Including Phase\u202fIII AT\u201101 with FDA Breakthrough Designation\" \/>\n<meta property=\"og:description\" content=\"Bayer AG (ETR:\u202fBAYN) announced an agreement with Attralus, Inc. to acquire two investigational molecular imaging tracers for cardiac amyloidosis diagnosis: AT\u201101 (124\u2011Iodine\u2011evuzamitide) and AT\u201105 (PAR\u2011Peptide + technetium\u201199m), bolstering Bayer\u2019s precision cardiology portfolio with a first\u2011in\u2011class PET agent holding FDA Breakthrough Therapy Designation.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=53944\" \/>\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=\"2026-01-13T12:46:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-13T12:47:01+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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