Bayer’s evuzamitide posts 94% sensitivity in Phase III cardiac amyloidosis study

Detailed results from the Phase III REVEAL study evaluating Bayer's iodine 124 evuzamitide as a PET diagnostic for cardiac amyloidosis met both primary endpoints, Bayer reported in a late-breaking presentation at the European Society of Cardiology Congress in Munich on August 30, 2026, with simultaneous publication in JAMA. The data provide the numerical foundation for a regulatory submission that could establish the first FDA-approved PET imaging agent specifically labeled for cardiac amyloidosis diagnosis.

The multicenter, open-label, single-arm Phase III study evaluated 170 adults with suspected cardiac amyloidosis across 18 US centers and was sponsored as an investigator-initiated trial by Brigham and Women's Hospital. By majority read — agreement between at least two of three independent readers blinded to clinical data — sensitivity was 94% (95% CI: 85%–98%) and specificity was 86% (95% CI: 77%–92%). Secondary analyses by amyloid subtype showed similar performance: sensitivity of 96% and specificity of 86% for transthyretin amyloidosis (ATTR), and sensitivity of 95% and specificity of 86% for light-chain amyloidosis (AL). Only one treatment-emergent adverse event (fatigue) was considered related to the tracer; no deaths occurred and no evuzamitide-related events led to discontinuation.

Evuzamitide is a radiolabeled synthetic peptide that binds amyloid fibrils irrespective of precursor protein type, enabling PET/CT detection of both ATTR and AL cardiac involvement from a single intravenous dose followed by imaging three to five hours post-injection. That distinguishes it from technetium-99m pyrophosphate (⁹⁹ᵐTc-PYP) scintigraphy, the dominant clinical tool, which detects ATTR selectively and performs poorly in AL amyloidosis, requiring concurrent hematologic testing to exclude AL before a positive scan can be attributed to ATTR. No single non-invasive test currently holds FDA approval for cardiac amyloidosis diagnosis; the ⁹⁹ᵐTc-PYP label covers cardiac imaging broadly, and its amyloid use is guideline-endorsed but not specifically approved.

Bayer acquired evuzamitide from Attralus, Inc. in January 2026, along with a second investigational SPECT tracer, AT-05, as part of a strategy to build a molecular imaging position in cardiovascular disease. The compound had previously received FDA Breakthrough Therapy Designation for PET imaging in suspected or known cardiac amyloidosis, along with Orphan Drug status for both AL and ATTR in the US and EU. Bayer has stated it plans to discuss the REVEAL data and a regulatory submission pathway with the FDA and other health authorities; no timeline has been disclosed.

Life Molecular Imaging's florbetaben (Neuraceq) is also in late-stage development for cardiac amyloidosis — its cardiac indication received FDA Fast Track Designation in January 2025 — providing a notable late-stage competitive parallel in the PET diagnostic space. Both programs target the same diagnostic gap, though evuzamitide's iodine-124 label and pan-amyloid peptide scaffold differ mechanistically from florbetaben's fluorine-18 stilbene chemistry. The REVEAL specificity figures — 84%–89% across individual readers — may draw scrutiny, although the investigators argued that the imperfect clinical reference standard could have misclassified some early disease as false-positive PET results.

---

Spot something wrong? Report an issue with this article