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Highlights
Imagion Biosystems shares jumped 44% to AUD 0.018 on 10 July 2025 following regulatory progress.
The company received formal written feedback from the U.S. FDA on its planned Phase 2 trial for HER2 breast cancer imaging.
IND application submission for the MagSense® HER2 imaging agent expected in Q3 2025.
Shares of Imagion Biosystems Limited (ASX:IBX) surged nearly 44% to AUD 0.018 on Thursday morning after the company announced progress in its regulatory discussions with the U.S. Food and Drug Administration (FDA) regarding its upcoming Phase 2 HER2 breast cancer clinical trial.
Imagion, a healthcare technology firm focused on cancer detection through its MagSense® molecular imaging platform, has received formal written feedback from the FDA on its proposed study plan. This marks a key step in the company’s preparation to submit an Investigational New Drug (IND) application for its MagSense® HER2 imaging agent.
According to the company, the FDA’s feedback was positive and constructive, offering regulatory guidance that supports the company's upcoming submission. Imagion executives are scheduled to meet with the FDA in person in the coming week to finalise the review process and prepare for the formal IND submission, which is expected to be lodged in the third quarter of the 2025 calendar year.
Executive Chairman Bob Proulx commented on the development, saying, “We view the feedback from the FDA as very encouraging and can now confidently press forward with the formal submission and plans for undertaking the Phase 2 clinical study knowing we are in good shape regarding the regulatory path.”
Advancing Non-Radioactive Cancer Detection
Imagion Biosystems is working to improve the early detection of cancer through its non-radioactive diagnostic imaging technology, combining nanotechnology and biotechnology. The company’s proprietary MagSense® technology is designed to provide higher specificity and earlier detection than conventional methods.
The upcoming Phase 2 study will focus on HER2-positive breast cancer, a subtype associated with aggressive tumour growth and accounting for approximately 20% of all breast cancer diagnoses. The company’s imaging agent aims to assist physicians in diagnosing and managing HER2-positive breast cancer more accurately by enabling targeted imaging without the need for radioactive tracers.
Share Price Momentum and Outlook
Investor sentiment has responded positively to the regulatory update, pushing Imagion’s share price up by 44% in early trading. The development follows ongoing engagement between Imagion’s clinical team and the FDA, which has now entered its final stages before IND submission.
The company reaffirmed its plans to move forward with clinical development in line with regulatory requirements.
With the IND application scheduled for submission in Q3 2025, the company continues to build momentum in its mission to bring next-generation molecular imaging to the clinical setting.
About Imagion Biosystems
Imagion Biosystems Limited is an Australian-based biotechnology firm developing precision diagnostic molecular imaging technology. Its platform, MagSense®, combines biotechnology and nanotechnology to detect cancers and other diseases earlier and with improved accuracy.






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