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Imagion Advances MagSense HER2 Program Toward FDA IND and Bolsters US Leadership

Story Highlights
  • Imagion completed manufacturing and testing of its MagSense HER2 agent, preparing an FDA IND.
  • Optimised MRI protocols and new US leadership aim to boost trial success and growth.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Imagion Advances MagSense HER2 Program Toward FDA IND and Bolsters US Leadership

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Imagion Biosystems Ltd. ( (AU:IBX) ) has shared an update.

Imagion Biosystems has completed manufacturing and independent analytical testing of its MagSense® HER2 Imaging Agent, clearing a key technical hurdle toward filing an Investigational New Drug application with the U.S. FDA in the first quarter of 2026 for a planned Phase 2 clinical trial. A collaboration with MRI specialists at Wayne State University produced an optimized imaging protocol that allows for a one‑third dose reduction versus the Phase 1 trial and improved MRI sequence selection, changes that could enhance patient safety, image quality, and the agent’s clinical adoption prospects; in parallel, the company strengthened its U.S. leadership by appointing former Chief Business Officer Ward Detwiler as president of its U.S. subsidiary to drive growth and operational development.

The most recent analyst rating on (AU:IBX) stock is a Hold with a A$0.03 price target. To see the full list of analyst forecasts on Imagion Biosystems Ltd. stock, see the AU:IBX Stock Forecast page.

More about Imagion Biosystems Ltd.

Imagion Biosystems Ltd is an Australian-listed medical technology company focused on improving cancer outcomes through its proprietary MagSense® imaging technology. The company is developing targeted magnetic nanoparticle-based imaging agents, with a particular focus on HER2-positive breast cancer, aiming to enhance early detection and provide more precise, MRI-based diagnostic tools for clinicians.

Average Trading Volume: 3,110,510

Technical Sentiment Signal: Sell

Current Market Cap: A$12.76M

Learn more about IBX stock on TipRanks’ Stock Analysis page.

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