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Imagion Biosystems Limited (ASX:IBX)

ALERT: Price-sensitive ASX Announcement for IBX
Current share price for IBX : $0.012 -0.005 (-29.41%)+
Announcement
Release
2 Jun 2026 9:05AM
Price at Release
$0.017
Full Release
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Summary
Imagion Biosystems Limited, trading on ASX as IBX, has received clearance from the US FDA for its IND application to commence a Phase 1b/2 clinical trial of the MagSense® HER2 Imaging Agent in patients with HER2+ breast cancer. The trial, set to start patient recruitment in the third quarter of 2026, will proceed in three phases over 18-24 months to assess the safety, optimized imaging protocol, and diagnostic performance of the imaging agent, emphasizing its potential to advance cancer detection with precision and without the use of radioactivity.
Key Points
  • Imagion Biosystems Limited (ASX: IBX) received FDA clearance for its IND application for the MagSense® HER2 Imaging Agent.
  • The clearance allows the commencement of a Phase 1b/2 clinical trial in HER2+ breast cancer patients.
  • The trial will evaluate the safety, imaging protocol, and diagnostic performance of the MagSense® Imaging Agent.
  • The trial is designed in three parts and is expected to be completed in 18-24 months.
  • Patient recruitment is anticipated to begin in the third quarter of 2026.
  • Imagion Biosystems aims to improve cancer detection with the MagSense® technology without using radioactivity.
  • The technology is seen as transformative, offering molecular precision in medical imaging.
  • Dr. Eghtedari at City of Hope hospital in Los Angeles will serve as the principal investigator for the trial.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.