Latest Regulatory News

Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.

South Harz Potash Ltd has announced a pro-rata non-renounceable entitlement issue to raise approximately A$1.28 million, offering one new share for every three held plus free options. The capital raise aims to fund its dual-asset growth plans in Germany amid ongoing project development and acquisition efforts.

Actinogen Medical has locked in up to $13.8 million in non-dilutive funding tied to its R&D tax incentives, bolstering its cash position as it advances a pivotal Alzheimer’s disease clinical trial.

Green Critical Minerals’ McIntosh Graphite Project Pre-Feasibility Study confirms robust economics with a post-tax NPV of A$235 million and a 32.5-year mine life, underpinning plans for staged development and market entry.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

Rox Resources has completed its two-tranche placement, raising a total of $40 million to advance its Youanmi Gold Project development. The final tranche involved issuing 13.5 million shares to key institutional investors.

ECS Botanics has launched the globally acclaimed Terphogz™ cannabis strains, including The Original Z™, into the Australian medicinal market, marking a strategic expansion of its premium product portfolio.

Estrella Resources has confirmed a $5 million capital injection from a strategic investor exercising a tranche subscription option, underpinning its ambitious manganese and limestone projects in Timor-Leste.

New World Resources and Central Asia Metals have agreed to increase their takeover offer to 6.2 cents per share, surpassing a competing bid and reshaping the acquisition landscape.

Dimerix Limited has received a significant milestone payment from its Japanese partner FUSO Pharmaceutical, marking progress in the Phase 3 clinical trial of DMX-200 for kidney disease. This payment underscores the growing momentum behind Dimerix’s global licensing strategy.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

BlinkLab has secured US Institutional Review Board approval to proceed with the main phase of its FDA 510(k) trial for an AI-powered autism diagnostic tool, marking a key step toward regulatory clearance.