Latest Regulatory Submissions News

Actinogen Medical has reached a key milestone in its XanaMIA phase 2b/3 Alzheimer’s trial with over 100 participants enrolled, setting the stage for an interim analysis in January 2026. The company also secured a $13.8 million non-dilutive R&D funding facility to support ongoing development.

Avecho Biotechnology has ramped up recruitment in its pivotal Phase III insomnia trial and is advancing plans for regulatory approval and commercialization of its TPM®-enhanced CBD capsule, aiming to be the first over-the-counter CBD insomnia treatment in Australia.

Nexus Minerals has reported a significant new gold discovery at its Wallbrook Gold Project, highlighted by strong drilling results at the Payns Prospect, while progressing permitting for the Crusader-Templar deposit and maintaining a solid cash position.

BPH Energy’s June quarter update highlights ongoing legal proceedings over the PEP-11 permit, promising progress in AI-driven brain monitoring technology, and strategic moves toward hydrogen production facilities, supported by a robust cash reserve.

Artrya has launched its AI-powered Salix Coronary Anatomy platform in the U.S. and submitted its Coronary Plaque module for FDA clearance, marking a key step in its commercial expansion. A new five-year contract with Tanner Health signals the start of U.S. revenues.

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

D3 Energy has achieved a significant milestone with its maiden certified methane and helium reserves at ER315 in South Africa, enabling an early submission of its Production Right application. The reserves cover a small portion of the acreage but signal substantial upside potential.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

29Metals Limited's June Quarter 2025 report highlights steady production at Golden Grove with revised capital guidance, while Capricorn Copper remains suspended but progresses on key environmental and regulatory fronts.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.