Latest Regulatory Milestones News

Klevo Rewards Limited’s subsidiary Fly Wallet has secured key Mastercard compliance and earned over AUD 550,000 in incentives, marking a significant step in its payments platform evolution.

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

Terrain Minerals has initiated diamond drilling at its Smokebush Gold & Silver Project, advancing toward a maiden JORC Mineral Resource estimate targeted for mid-2026. The company’s exploration momentum continues with ongoing RC drilling at Lightning and upcoming programs at Wildflower.

Imricor Medical Systems has welcomed Oklahoma Heart Institute as the fourth U.S. site in its pivotal VISABL-AFL clinical trial, accelerating patient recruitment and the FDA approval pathway for its MRI-guided cardiac ablation technology.

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Rhythm Biosciences has secured a multi-year commercial manufacturing agreement with US-based Quansys Biosciences to produce ColoSTAT® reagent kits, paving the way for broader market rollout of its colorectal cancer diagnostic test.

Aura Consolidated Group and Qoria Limited have announced a merger to create AXQ, a global leader in digital safety and cybersecurity, backed by a US$75 million equity raise and targeting strong growth and innovation.

CurveBeam AI has received the first A$4 million tranche of a planned A$10 million strategic investment from a leading Chinese orthopaedic device company, marking a significant step in its expansion into the Chinese market.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Memphasys Limited secures significant repeat orders from Hamad Medical Corporation, marking a pivotal expansion of its Felix™ system across the MENA region.

Riversgold Limited has reported robust gold mineralisation from the final 16 drillholes of its 2025 campaign at the Northern Zone near Kalgoorlie, confirming expansion of the shallow oxide gold footprint. The company is set to commence its 2026 drilling program to further extend the resource.

RareX Limited has secured a pivotal mining lease for its Cummins Range Rare Earths Project in Western Australia, confirming some of the highest-grade gallium mineralisation in the country. The company also advances metallurgical testing and forges strategic US partnerships, positioning itself at the forefront of critical minerals development.