Bayer Announces Positive Phase III Results for New Cardiac Amyloidosis PET Radiotracer

Bayer announced positive results from its Phase III REVEAL study of an experimental heart imaging drug at the European Society of Cardiology Congress 2026 in Munich. The study tested Iodine 124 Evuzamitide, a PET radiotracer designed to diagnose cardiac amyloidosis, a serious heart disease caused by abnormal protein buildup. Hastings Tribune reported the study met its primary goals for detecting the disease accurately.
Among 170 patients who received the drug, 55 experienced at least one side effect within 30 days. The results were simultaneously published in The Journal of the American Medical Association, marking a significant milestone for Bayer's diagnostic imaging development in cardiology.
Cardiac amyloidosis happens when abnormal proteins accumulate in heart tissue. This buildup damages the heart's ability to pump blood and causes heart failure. Post Register notes that the disease comes in two main types: light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Early detection is critical because it allows doctors to start treatment before severe damage occurs.
Iodine 124 Evuzamitide is a PET radiotracer—a type of radioactive substance that helps doctors see disease inside the body. The drug specifically targets amyloid proteins in the heart. Barchart reported that the REVEAL study evaluated the drug's sensitivity and specificity, meaning how well it detects the disease and avoids false alarms. Brigham and Women's Hospital conducted the research.
The Phase III trial included 170 patients who received Iodine 124 Evuzamitide. During the first 30 days after treatment, 55 patients (32%) had at least one treatment-emergent adverse event. Las Vegas Sun reported that safety data and results from secondary endpoints covered both AL and ATTR amyloid types, giving doctors insight into how well the drug works across different amyloidosis forms.
The late-breaker presentation at Europe's biggest cardiology conference signals momentum for Bayer's diagnostic pipeline. Hastings Tribune noted that meeting primary endpoints opens the door to regulatory review and potential approval. If approved, Iodine 124 Evuzamitide could give cardiologists a powerful new tool to spot amyloidosis early, when doctors can still intervene to slow disease progression and improve patient survival.
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