Latest Regulatory Progress News

Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.

Neurotech International reports a dramatic reduction in half-year losses alongside significant clinical and regulatory progress for its lead cannabinoid therapy NTI164. The company also strengthens its cash position through a $4 million placement and a $4.7 million R&D tax refund.

ReNerve Limited reported a half-year loss of $2.72 million, up 47% from last year, as it expands its nerve repair product portfolio and secures new regulatory approvals in Asia-Pacific.

Immuron Limited reported a narrower half-year loss alongside record sales growth and FDA approval for its IMM-529 drug candidate, signalling promising clinical and commercial momentum.

Firebrick Pharma reports a reduced half-year loss of $1.26 million while launching its Nasodine Throat Spray in Singapore and Fiji, with regulatory approval pending in the Philippines.

Greenwing Resources has significantly enhanced the economics of its Que River Project following a sharp rise in key metal prices, nearly doubling projected cash flows and advancing a two-stage development plan.

Clarity Pharmaceuticals reports another metastatic prostate cancer patient achieving undetectable disease markers in its Phase II SECuRE trial, reinforcing promising efficacy and safety of its Cu-SAR-bisPSMA radiopharmaceutical.

Sunshine Metals has released a comprehensive scoping study for its Liontown Gold Operation in North Queensland, outlining a promising initial production target of approximately 75,000 ounces of gold and 654,000 ounces of silver. The study highlights strong financial metrics and a pathway to production by late 2026, with further resource updates expected.

Aurizon Holdings reported a 9% rise in underlying EBITDA to $891 million for the half-year ending December 2025, driven by higher volumes and yields in coal and bulk segments. The company also raised its full-year dividend guidance and extended its share buy-back program.

Sarytogan Graphite Limited has upgraded its Mineral Resource Estimate to include 5.4 million tonnes of Measured graphite, underpinning a multi-decade mine life in Kazakhstan. This milestone supports the ongoing Definitive Feasibility Study due mid-2026.

Vysarn Limited and the Kariyarra Aboriginal Corporation have advanced their Kariyarra Water Scheme with a key groundwater licence application and a bid to supply bulk water to Port Hedland.

Novo Resources has significantly increased the Exploration Target at its Belltopper Gold Project in Victoria, with multiple high-grade prospects across its Australian portfolio and drilling programs planned throughout 2026.