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Imagion Biosystems Advances with FDA IND Filing for HER2 Breast Cancer Imaging Trial

9:28am on Monday 2nd of February, 2026 AEDT Healthcare
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Imagion Biosystems Advances with FDA IND Filing for HER2 Breast Cancer Imaging Trial

9:28am on Monday 2nd of February, 2026 AEDT
Key Points
  • IND application lodged with U.S. FDA for MagSense® HER2 Imaging Agent
  • Phase 2 clinical trial planned to start post-FDA approval in early 2026
  • Strategic trial partners engaged and study site selection underway
  • Trial designed in three parts to assess safety, dosing, and diagnostic performance
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