Latest Regulatory Milestones News

Starpharma reports encouraging FDA feedback on its DEP® SN38 candidate for ovarian cancer and prepares for product launches in Saudi Arabia and UAE, supported by a solid $20.3 million cash position.

Artrya Limited reports solid progress on its FDA 510(k) application and secures a A$5 million capital raise, positioning itself for imminent commercial rollout in the US healthcare sector.

Neurizon Therapeutics reports encouraging 8-month interim results for its ALS drug NUZ-001, secures Orphan Medicinal Product Designation in Europe, and raises $885,000 through a share placement, maintaining a robust $14 million cash position.

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.

Truscott Mining Corporation reports significant progress in its Tennant Creek gold projects, underpinned by robust research and plans for expanded drilling funded through new capital raising.

Richmond Vanadium Technology has submitted its draft Environmental Impact Statement for the Richmond - Julia Creek Vanadium Project and progressed innovative metallurgical test work, positioning itself for a development decision in 2025.

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.

Empire Energy has successfully drilled its longest well to date, secured a $65 million financing package, and received environmental approval for its Carpentaria Pilot Project, setting the stage for first gas deliveries later in 2025.

EMVision Medical Devices reports strong progress in clinical trials for its emu™ Bedside Scanner, backed by robust cash reserves and strategic non-dilutive funding. The company is poised to commence pivotal FDA validation trials, marking a key step toward commercialisation.

EBR Systems has signed a long-term lease for a 51,000 sq ft facility in Santa Clara, California, positioning itself for significant manufacturing expansion and future growth in wireless cardiac pacing technology.