Imagion Biosystems Says No Issues Raised After US FDA Meeting; Shares Up 29%
MT Newswires Live
Jul 15, 2025
Imagion Biosystems (ASX:IBX) said no issues were identified following the meeting with the US Food and Drug Administration (FDA) on plans to undertake a phase two trial of the MagSense HER2 imaging agent in breast cancer detection, according to a Tuesday filing with the Australian bourse.
The company will expedite manufacturing of the imaging agent for the trial, with final manufacturing and testing expected to be completed in the third quarter of the year, the filing said.
Shares rose 29% in midday trade on Tuesday.
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