Bayer reports REVEAL study met primary endpoints

Bayer (BAYRY) announced 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. The study met the primary endpoints of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation. Bayer plans to present the complete results at an upcoming scientific congress. I 124 evuzamitide is an investigational PET radiotracer-a radioactive diagnostic imaging agent injected into the body before a PET scan to assist with visualization-being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication. The compound was previously granted Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis as well as Orphan Drug status for both light-chain amyloidosis and transthyretin amyloidosis in the U.S. and the EU. Bayer plans to discuss the data and submission for regulatory approval with the FDA and other health authorities.