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Imagion Biosystems Ltd. ( (AU:IBX) ) has issued an announcement.
Imagion Biosystems has submitted its first Investigational New Drug application to the U.S. Food and Drug Administration for its MagSense® HER2 imaging agent, a key step toward launching a Phase 2 clinical trial in HER2-positive breast cancer across multiple U.S. sites as early as the first quarter of 2026. The Phase 2 trial, designed in three parts and expected to run for 18–24 months after FDA acceptance, will further assess safety, refine dosing and imaging protocols, and evaluate diagnostic performance, while also generating data on economic impact, patient outcomes and AI-enabled quantitative imaging; with strategic trial partners already engaged and site preparations under way, the milestone signals operational readiness and advances Imagion’s efforts to validate its platform and strengthen its position in cancer imaging.
The most recent analyst rating on (AU:IBX) stock is a Buy 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 Limited (ASX: IBX) is a medical imaging company focused on improving cancer diagnosis through its proprietary MagSense® molecular imaging technology. The company is currently targeting HER2-positive breast cancer and aims to enable earlier and more accurate detection, with an emphasis on demonstrating clinical value, patient outcome benefits and potential cost-of-care advantages in oncology imaging.
Average Trading Volume: 3,154,907
Technical Sentiment Signal: Sell
Current Market Cap: A$11.77M
See more data about IBX stock on TipRanks’ Stock Analysis page.