Latest Regulatory News

CurveBeam AI has reported a record quarter for HiRise™ device purchase orders, driven by a strategic expansion with Stryker in Australia and New Zealand. The company also advanced its FDA regulatory pathway for its BMD module, setting sights on mid-2025 submission.

Actinogen Medical accelerates recruitment in its pivotal XanaMIA Alzheimer's trial while securing a strong cash position of $22.9 million, underpinning its late-stage development and commercial readiness.

Aroa Biosurgery has reported its first quarter of positive operating cash flow since listing on the ASX in 2020, alongside robust revenue growth projections and new regulatory approvals across key international markets.

Universal Biosensors is expanding its handheld testing portfolio with the upcoming AQUASCOUT water sensor and growing sales of its FDA-approved Xprecia Prime blood coagulation device, targeting multi-billion-dollar markets.

Syntara Limited has reported encouraging interim Phase 2 trial results for its lead drug candidate SNT-5505 in myelofibrosis, alongside a successful A$15 million capital raise to advance multiple clinical programs.

Aruma Resources advances its exploration portfolio with standout assay results at Fiery Creek and strategic leadership changes, setting the stage for upcoming drilling campaigns.

Black Rock Mining has cleared key regulatory hurdles for POSCO's US$40 million equity injection and secured US$179 million in debt facilities, setting the stage for construction of its Mahenge Graphite Project in Tanzania.

MTM Critical Metals reports solid progress on its US-based Flash Joule Heating demonstration plant, targeting a Q4 2025 start-up in Texas amid favorable regulatory and funding prospects.

Sarytogan Graphite Limited has secured a key mining license and demonstrated promising product applications, supported by a significant investment from the European Bank for Reconstruction and Development. The company is progressing towards customer qualification and offtake agreements while expanding exploration efforts.

Imugene Limited has secured A$20 million through convertible notes as part of a broader A$46 million capital raise, aiming to advance its promising immuno-oncology pipeline.

Brightstar Resources has initiated ore haulage from its Laverton Hub under a key Ore Purchase Agreement, setting the stage for its first gold pour in March 2025 and positioning the company for growth amid record gold prices.

The Star Entertainment Group has agreed to sell its Sydney Event Centre assets to Foundation Theatres for $60 million, marking a strategic shift in its property portfolio.