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Imagion Biosystems Limited (ASX:IBX)

ALERT: Price-sensitive ASX Announcement for IBX
Current share price for IBX : $0.015 -0.009 (-37.50%)+
Announcement
Release
2 Feb 2026 9:17AM
Price at Release
$0.024
Full Release
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Summary
Imagion Biosystems Limited, traded on the ASX as IBX, has marked a significant milestone by submitting its Investigational New Drug (IND) application to the U.S. FDA for the MagSense® HER2 Imaging Agent. This submission is a pivotal step in the clinical development of their proprietary imaging platform aimed at improving early cancer detection. Upon FDA approval, the Phase 2 trial will commence across various U.S. sites, anticipated to start as early as Q1 2026. The trial is designed in three parts to assess safety, dosing, and diagnostic performance, with completion expected in 18-24 months post-approval. The strategic engagement of trial partners is complete, enhancing readiness for the trial's successful execution.
Key Points
  • Imagion Biosystems lodged IND application with FDA for MagSense® HER2 Imaging Agent.
  • The IND marks a major milestone for the MagSense® platform.
  • Phase 2 Clinical Trial to begin after FDA approval, expected early 2026.
  • Trial designed in three parts for safety, dosing, and performance evaluation.
  • Strategic trial partner engagement process is complete.
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.