Latest Regulatory Milestones News

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.

Zelira Therapeutics has received a fourth funding tranche, bringing total investment to US$3.25 million to support FDA clinical trials of its HOPE® 1 cannabinoid medicine targeting irritability in autism spectrum disorder and Phelan-McDermid Syndrome.

Perpetual Resources reports significant assay results confirming ultra-high grade spodumene at its Isabella Lithium Project and initiates metallurgical testing at the Raptor Rare Earth Project, backed by a strategic MOU with Minas Gerais government and a $1 million capital raise.

Altamin Limited has completed the acquisition of Appian Italy’s 29.85% stake in Vedra Metals, gaining 100% ownership of the Gorno Project and positioning itself for streamlined development or sale.

Winsome Resources has taken a significant step forward in developing its Adina Lithium Project by submitting the Preliminary Information Statement to Quebec authorities, initiating a structured permitting process and enhancing stakeholder engagement.

Clarity Pharmaceuticals has secured a second FDA Fast Track Designation for its 64Cu-SAR-bisPSMA diagnostic agent, aiming to revolutionize prostate cancer imaging and speed regulatory approval.

DeSoto Resources has secured a strategic manganese project in Brazil and received pioneering drilling approvals in Australia's Northern Territory, setting the stage for significant exploration activity in 2025.

Memphasys Limited marks a pivotal quarter with the completion of clinical trials for its Felix™ System, strategic market expansions in Greater China and the Middle East, and a successful capital raise to fuel growth.