Articles from Imagion Biosystems, Ltd.

Imagion Biosystems Secures AU$3.75M in Capital Raise Following FDA Clearance of Phase 2 Clinical Trial
Imagion Biosystems, Ltd. (ASX: IBX) announced that it has secured firm commitments for AU$3.75M (US$2.59M) in new capital following the FDA’s clearance of the company’s IND application for a Phase 2 clinical trial. The raise will fund the commencement of the clinical trial of the MagSense® imaging agent in HER2+ breast cancer. The company has already begun trial activation activities and expects to begin patient recruitment later this year.
By Imagion Biosystems, Ltd. · Via Business Wire · June 25, 2026
Imagion Biosystems’ IND Application for MagSense® Phase 2 Clinical Trial Clears FDA Review
Imagion Biosystems, Ltd. (ASX: IBX) has announced that the US Food and Drug Administration (FDA) completed its review of the company’s investigational new drug (IND) application, issuing a “Study May Proceed” letter for Phase 1b/2 clinical trials of the MagSense® Imaging Agent in HER2+ breast cancer.
By Imagion Biosystems, Ltd. · Via Business Wire · June 2, 2026
Medical-imaging company Imagion Biosystems Lodges IND with FDA for Phase 2 Trial of MagSense® HER2 targeted imaging agent
Imagion Biosystems, Ltd. (ASX: IBX) announced that the company has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its MagSense® targeted imaging agent. Following FDA approval, the company expects to start a Phase 2 clinical trial with the imaging agent for the detection of nodal metastases in HER2+ breast cancer patients.
By Imagion Biosystems, Ltd. · Via Business Wire · February 3, 2026
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