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Investigational PET Tracer Iodine 124 Evuzamitide from Bayer Met Primary Endpoints in Phase III Study in Patients Suspected to Have Cardiac Amyloidosis
BERLIN & WHIPPANY, N.J., May 07, 2026--Bayer today announced positive topline results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital that evaluated the investigational PET/CT radiotracer I 124 evuzamitide.1,5 The study met the primary endpoints of sensitivity (the ability of a test to identify individuals who have the condition) and specificity (the ability of a test to identify individuals who do not have the condition) for the diagnosis of card
About this update from Bayer Ag
[{"type":"text","content":"KEY FACTS","length":9,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"The Phase III REVEAL study met its primary endpoints demonstrating sensitivity and specificity of iodine 124 evuzamitide (I 124 evuzamitide) positron emission tomography computed tomography (PET/CT) for the diagnosis of cardiac amyloidosis based on visual scan interpretation1","length":276,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"I 124 evuzamitide, an investigational radiotracer for the diagnosis of cardiac amyloidosis, was previously granted Breakthrough Therapy Designation for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis 2","length":252,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"The compound also previously received Orphan Drug status in the U.S. and EU 3","length":77,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Cardiac amyloidosis typically takes between 2-4 years from symptom onset to diagnosis,4 yet there is no single, non-invasive test for the reliable detection and diagnosis of the disease","length":185,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Bayer plans to discuss the data and submission for regulatory approval with the FDA and other health authorities","length":112,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":902,"olType":false},{"type":"text","content":"POSITIVE TOPLINE DATA RESULTS","length":29,"tagName":"p"},{"type":"text","content":"Not intended for UK Media","length":25,"tagName":"p"},{"type":"text","content":"BERLIN & WHIPPANY, N.J., May 07, 2026--(BUSINESS WIRE)--Bayer today announced positive topline results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital that evaluated the investigational PET/CT radiotracer I 124 evuzamitide.1,5 The study met the primary endpoints of sensitivity (the ability of a test to identify individuals who have the condition) and specificity (the ability of a test to identify individuals who do not have the condition) for the diagnosis of cardiac amyloidosis based on visual scan interpretation.1 Bayer plans to present the complete results at an upcoming scientific congress.","length":654,"tagName":"p"},{"type":"text","content":"I 124 evuzamitide is an investigational PET radi...