IBX's IND Application Lodged with FDA for HER2 Phase 2 Trial
Filed with ASX · · 3 pages · English
➢ Imagion Biosystems has lodged its Investigational New Drug (IND) application for the MagSense® HER2 Imaging Agent to the U.S. Food and Drug Administration (FDA) ➢ IND Submission marks a major milestone in the clinical development of the company’s proprietary MagSense® platform ➢ Phase 2 Clinical Trial enrollment planned to commence following FDA approval ➢ Strategic trial partners engaged, study
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Story so far
Earlier from Imagion Biosystems
- Appendix 4C and Quarterly Activities Report - December 2025
- Mercer Convertible Securities Conversion and Amendment
- Positive Final WSU Trial Results To Support IND Submission
- Positive Results Received from WSU on MagSense Dosage
- Appendix 4C and Quarterly Activities Report - September 2025
Later from Imagion Biosystems
- Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent
- FY25 Appendix 4E and Annual Report
- Appendix 4C and Quarterly Activities Report - March 2026
- Imagion Biosystems Receives IND Clearance from US FDA
- Imagion Biosystems’ IND Application for MagSense® Phase 2 Clinical Trial Clears FDA Review
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