Image source: © 2025 Krish Capital Pty. Ltd.
Highlights
Imagion Biosystems shares surged 28.6% to 1.8 cents on 15 July 2025 following a regulatory update on its MagSense® HER2 breast cancer program.
The U.S. FDA raised no issues that could impact the planned Phase 2 trial, paving the way for an IND application in Q3 2025.
Manufacturing of the MagSense® HER2 imaging agent is advancing, with final testing expected to be completed by Q3 2025.
Imagion Biosystems Limited (ASX:IBX), a clinical-stage company developing precision diagnostic imaging for cancer detection, announced a major milestone in its MagSense® HER2 breast cancer program, triggering a 28.6% rise in share price to 1.8 cents per share.
The company recently held a videoconference meeting with the U.S. Food and Drug Administration (FDA) to discuss plans for its upcoming Phase 2 clinical trial of the MagSense® HER2 imaging agent. The FDA provided clarifying feedback on the trial’s structure and operations, and no regulatory issues were identified that would hinder the company’s current development timeline.
Phase 2 Clinical Trial Plans on Track
Led by Executive Chairman Bob Proulx, Chief Business Officer Ward Detwiler, and Medical Affairs Advisor Dr. Susan Harvey, the company’s clinical team attended the FDA meeting to address the Agency’s queries. The discussion also included input on the broader clinical and commercial pathway for the MagSense® platform.
Following this meeting, Imagion is preparing to submit an Investigational New Drug (IND) application in the third quarter of calendar year 2025, setting the stage for a multi-site, open-label study led by Principal Investigator Dr. William Dooley of the University of Oklahoma Health Sciences College of Medicine.
Dr. Dooley, an accomplished surgical oncologist and breast cancer expert, highlighted the potential of MagSense® technology to aid in assessing biological responses to neoadjuvant treatment, which could significantly improve pre-surgical decision-making.
Manufacturing Progress Underway
Imagion also confirmed that final manufacturing and testing of its MagSense® HER2 imaging agent is underway, with completion expected in Q3 2025. This step is critical for initiating the Phase 2 trial, which will evaluate the imaging agent’s ability to detect and stage HER2-positive breast cancer without radiation exposure.
Transforming Cancer Detection
The company’s MagSense® technology combines nanotechnology with molecular imaging, offering a non-radioactive approach to cancer detection with high specificity. The HER2 breast cancer program is a key component of Imagion’s broader goal to transform diagnostic accuracy in oncology.






Please wait processing your request...