Shots:
- Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis
- Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted for regulatory approval with the US FDA & other health authorities
- I 124 evuzamitide has received Breakthrough Therapy Designation for PET imaging in suspected or known cardiac amyloidosis, along with Orphan Drug status for AL and ATTR amyloidosis in the US and EU
Ref: Businesswire | Image: Bayer | Press Release
Related News: Bayer to Acquire Perfuse Therapeutics for ~$2.45B
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