Imagion Biosystems Advances Toward Phase 2 Trial for MagSense HER2 Breast Cancer Imaging

Imagion Biosystems Limited (ASX: IBX) has announced progress in advancing its proprietary MagSense® HER2 Breast Cancer diagnostic imaging program, including a positive regulatory interaction with the U.S. Food and Drug Administration (FDA). The Company held a videoconference with FDA officials following a written response regarding its planned Phase 2 clinical trial for the MagSense® HER2 imaging agent in the United States.

The meeting, attended by Imagion's Executive Chairman Bob Proulx, Chief Business Officer Ward Detwiler, and Medical Affairs Advisor Dr. Susan Harvey, aimed to clarify the FDA's feedback on trial design and execution. Significantly, no issues were raised that would hinder the Company's current trial plans. Encouraged by the Agency's engagement, Imagion now plans to file its Investigational New Drug (IND) application in Q3 of calendar year 2025. This development marks a key milestone in Imagion's mission to transform cancer detection through its MagSense® technology.

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