By Fineline Cube Bayer AG (ETR: BAYN) announced an agreement with Attralus, Inc. to acquire two investigational molecular imaging tracers for cardiac amyloidosis diagnosis: AT‑01 (124‑Iodine‑evuzamitide) and AT‑05 (PAR‑Peptide + technetium‑99m), bolstering Bayer’s precision cardiology portfolio with a first‑in‑class PET agent holding FDA Breakthrough Therapy Designation.
Regulatory & Deal Milestone
| Item | Detail |
|---|---|
| Companies | Bayer AG (acquirer) and Attralus, Inc. (originator) |
| Assets Acquired | AT‑01 (PET tracer) and AT‑05 (SPECT tracer) |
| Indication | Cardiac amyloidosis diagnosis |
| AT‑01 Status | Phase III; FDA Breakthrough Therapy Designation (first for cardiac amyloidosis) |
| AT‑05 Status | Phase I development |
| Global Patient Pool | ~400,000 affected; majority underdiagnosed |
| Deal Structure | Undisclosed financial terms; technology transfer and development partnership |
Technology Profile & Clinical Advancement
- Cardiac Amyloidosis: Rare, fatal heart disease characterized by amyloid fibril deposition; current diagnosis often delayed due to lack of specific, non‑invasive tools
- AT‑01:
- Pan‑amyloid PET imaging agent labeled with Iodine‑124
- Detects all systemic amyloidosis types (ATTR wild‑type/hereditary, AL) in heart, kidneys, liver, and spleen
- Non‑invasive, whole‑body imaging with high sensitivity/specificity
- Regulatory Advantage: BTD enables accelerated FDA review and enhanced engagement
- AT‑05:
- SPECT tracer using technetium‑99m (widely available radioisotope)
- Provides alternative diagnostic option for centers without PET infrastructure
- Phase I safety and biodistribution studies ongoing
Market Opportunity & Competitive Landscape
| Parameter | 2026E | 2027E | 2028E |
|---|---|---|---|
| Global Cardiac Amyloidosis Diagnoses | 45,000 | 55,000 | 70,000 |
| Estimated Imaging Market (USD) | $280 million | $360 million | $450 million |
| PET vs. SPECT Share | 60 % / 40 % | 65 % / 35 % | 70 % / 30 % |
| AT‑01 Peak Market Share (if approved) | 0 % | 15 % | 28 % |
| Revenue Forecast (AT‑01 only) | – | $32 million | $88 million |
- Competitive Environment:
- Siemens Healthineers and GE Healthcare dominate cardiac PET radiotracer distribution
- Currently approved agents: No PET/SPECT tracer specifically approved for cardiac amyloidosis; diagnosis relies on PYP scintigraphy (limited availability) and biopsy (invasive)
- Bayer’s Strategic Moat: AT‑01’s BTD and pan‑amyloid capability position Bayer as first‑mover in a blue‑ocean diagnostic segment
- Synergies: Integrates with Bayer’s Vericiguat (heart failure) and Asundexian (antithrombotic) cardiology pipeline for comprehensive amyloidosis patient management
Strategic Positioning & Next Steps
- Development Path:
- AT‑01 Phase III data expected Q4 2026; NDA submission H1 2027
- AT‑05 Phase I completion Q3 2026; pivotal study initiation Q1 2027
- Manufacturing: Leverage Bayer’s Berkeley, CA radiopharmacy for I‑124 production and global distribution
- Commercial Readiness: Bayer’s 300‑person US cardiology sales force to be trained on amyloidosis diagnostics; KOL engagement initiated at 50 heart failure centers
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approval timelines, market penetration, and revenue projections for AT‑01 and AT‑05. Actual results may differ due to clinical trial outcomes, competitive responses, and radiopharmaceutical supply chain constraints.-Fineline Info & Tech