Latest Breast Cancer News

Imagion Biosystems has secured central ethics approval for its US Phase 1b/2 trial of the MagSense HER2 imaging agent, removing a key requirement before recruitment can begin. Site activation is now underway, but no patient has yet been enrolled and the announcement provides no clinical data.

Imagion Biosystems has signed nanoComposix to resume GMP-aligned manufacturing of the MagSense nanoparticle core, a move designed to support its FDA-cleared HER2 breast cancer programme without the fixed cost of an in-house facility. The agreement improves manufacturing readiness, but its value, duration and production commitments remain undisclosed.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

Imagion Biosystems has signed key CRO work orders and completed manufacturing of its MagSense HER2 Imaging Agent, advancing its Phase 1b/2 clinical trial targeting HER2+ breast cancer. Trial initiation is underway with seven prospective sites, including contract talks with the first US clinical site.

BCAL Diagnostics has increased its shareholding in Genetic Signatures to nearly a fifth, aiming to leverage infectious disease technology to complement its cancer detection portfolio.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

Pro Medicus delivered a robust FY26 with 28% underlying revenue growth, a surge in new contract wins worth $407 million, and a 25% increase in fully franked dividends, underpinned by strong AI product development and rapid implementations.

BCAL Diagnostics has strengthened its leadership, advanced breast cancer detection tests, and secured key funding and strategic investments to underpin its FY2027 growth plans.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Starpharma Holdings is raising approximately $32 million through a fully underwritten 1-for-7.5 renounceable entitlement offer priced at $0.57 per share, discounting the stock by 25%. Proceeds will fund the DEP HER2-Lu Phase 1 trial and expand its dendrimer-based oncology pipeline.

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.