Latest Regulatory Progress News

Actinogen Medical has fast-tracked enrolment in its pivotal Alzheimer’s trial, secured a clear FDA regulatory path, and strengthened its financial position with funding extending its runway to mid-2026.

Lumos Diagnostics reported steady quarterly revenue with a 300% surge in product sales, driven by its flagship FebriDx® test. The company inked a landmark US$317 million exclusive U.S. distribution agreement and awaits FDA feedback on its CLIA waiver application.

E79 Gold Mines has reported outstanding high-grade copper and gold assay results from its Mountain Home Project in the Northern Territory, significantly expanding the known mineralised area and setting the stage for drilling in 2026.

Alcoa Corporation reported a $232 million net income in Q3 2025 despite significant restructuring costs, driven by increased alumina and aluminum production and strategic asset sales.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

ACDC Metals reports compelling mineralogy results from its Goschen Central project, highlighting elevated rare earth element grades that reinforce its economic potential. The announcement coincides with strategic momentum from the Australia-US Critical Minerals Framework, positioning the project as a key player in global supply chains.

BPM Minerals has secured the Forelands Gold Project with promising high-grade intercepts and divested its Claw Gold Project to Capricorn Metals, bolstering its cash position ahead of upcoming drilling.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

PainChek Limited has appointed Sasha Grant as Head of Growth for its AI-powered Infant App, aiming to scale its presence in a $15 billion global market. Early Australian adoption shows promising conversion rates as the company prepares for international expansion.

Ark Mines has secured Environmental Authority approval for its Sandy Mitchell Rare Earths project in Queensland, marking a crucial step towards obtaining its Mining Licence. The company has also completed a major drilling program, setting the stage for an upcoming Pre-Feasibility Study.

PolyNovo Limited has appointed Bruce Peatey as its new CEO, bringing extensive international healthcare experience to drive the company’s next growth phase. Peatey’s leadership is expected to accelerate PolyNovo’s expansion into new markets and outpatient care.

EVE Health Group Limited has launched a $1.1 million capital raising via a placement to fund the commercial rollout of its two pharmaceutical products, Dyspro and Libbo. The offer includes shares and options, with some subject to shareholder approval.