IMAGION BIOSYSTEMS ORD
Imagion Biosystems Starts Manufacture of MagSense Imaging Agent for Phase 2 HER2 Breast Cancer Trial
Imagion Biosystems (ASX: IBX) has commenced manufacturing of its MagSense imaging agent ahead of a Phase 2 HER2 breast cancer clinical trial to start in the US before year end. The agent will assess axillary nodal disease in patients diagnosed with HER2+ breast cancer and Imagion believes it will be of significant clinical value to […]
Imagion Biosystems Gains FDA Fast-Track Approval for MagSense HER2 Breast Cancer Imaging Agent
Imagion Biosystems (ASX: IBX) has announced it will fast-track a new batch of MagSense HER2 imaging agent ahead of a Phase 2 breast cancer trial this year. The decision follows a meeting with the US Food and Drug Administration where Imagion offered detailed responses on the structure and operation of the planned trial. The agency’s […]
Imagion Biosystems advances MagSense HER2 imaging agent with FDA application
Cancer detection specialist Imagion Biosystems (ASX: IBX) has taken the next step in progressing its MagSense HER2 imaging agent, lodging an application with the US Food and Drug Administration (FDA). The application for initiated manufacturing of MagSense HER2 is an essential requirement for filing an Investigational New Drug (IND) application with the FDA in mid-2025. […]
Imagion Biosystems presents interim data from MagSense study into breast cancer detection
Cancer detection technology developer Imagion Biosystems (ASX: IBX) has reported a maiden set of results relating to exploratory endpoints for its phase 1 MagSense HER2 breast cancer study. The interim data pertains to a cohort of the first six patients participating in the trial. Interim results were presented at the San Antonio Breast Cancer Symposium […]