Latest Imagion Biosystems (ASX:IBX) News

A single exploration name blew the doors off the leaderboard, while two well-known uranium plays and a Nevada explorer sank hard. Behind the noise: deals got closer to completion, big raisings reset prices, and several “good news” gaps didn’t survive the week.

A single diagnostics update sparked a breakout week, while a handful of biotech names sold off hard despite busy newsflow. Capital raisings, takeover steps and US market pushes kept healthcare in motion heading into mid-February milestones.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

A handful of healthcare names did the heavy lifting this week, driven by FDA wins, guideline upgrades, and big shifts in sales and cashflow. The flip side: several clinical-stage stocks fell hard as investors stayed picky about near-term proof and funding.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

Imagion Biosystems has completed the conversion of its first tranche convertible notes with Mercer Street, issuing over 3 million shares, while renegotiating terms on the second tranche to extend maturity and reduce debt.

Imagion Biosystems is set to submit its Investigational New Drug application for the MagSense® HER2 breast cancer imaging agent in December 2025, paving the way for a Phase 2 clinical trial in early 2026. Collaboration with Wayne State University has refined the trial design, promising improved patient safety and diagnostic precision.

Imagion Biosystems reports encouraging findings from its Wayne State University collaboration, supporting a lower dose for its MagSense® HER2 imaging agent ahead of a planned FDA IND submission in Q4 2025.

Imagion Biosystems has made significant strides toward filing an IND application for its MagSense® HER2 breast cancer imaging agent, supported by positive FDA feedback and a recent $3.5 million capital raise to fund upcoming clinical trials.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent, progressing toward a Phase 2 clinical trial with strong collaborations and a recent AU$3.5 million capital raise.

Imagion Biosystems has completed the second tranche of its $3.5 million placement, raising $2.85 million to advance its proprietary MagSense® imaging technology targeting breast, prostate, and ovarian cancers.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.