Latest Regulatory Milestones News

Rhythm Biosciences has begun commercialising its blood-based colorectal cancer test, ColoSTAT®, following key accreditations and validation. The company also secured a strategic partnership with NHS England and expanded its geneType™ platform globally.

Celsius Resources has released a Definitive Feasibility Study for its Maalinao-Caigutan-Biyog (MCB) Copper-Gold Project, confirming robust economics and a 35-year mine life. The study highlights strong returns, low operating costs, and a clear path to development in the Philippines.

Cambium Bio has strengthened its financial footing with a $0.6 million R&D tax refund and a $2.4 million strategic placement, setting the stage for pivotal Phase 3 clinical trials of its lead ophthalmology candidate.

Nyrada Inc. has secured ethics approval to launch a Phase IIa clinical trial for its heart attack drug Xolatryp®, with patient recruitment set for March 2026. The company maintains a solid cash position of AU$7.12 million as it expands its research into oncology.

Arovella Therapeutics has filed an IND application for its lead CAR-iNKT therapy ALA-101, selected a CRO for its upcoming phase 1 trial, and secured $19.4 million in cash to fund clinical progress and pipeline expansion.

Prodigy Gold NL reported significant gold intercepts from its Tanami North Project, alongside environmental baseline studies and a new 3D structural collaboration with CSIRO, positioning the company for future mining development.

Memphasys Limited has achieved its first material revenues following CE Mark approval for its Felix™ System, activating multi-year contracts across Europe, the Middle East, and Asia. The company is now transitioning from regulatory preparation to global commercial rollout with a focus on recurring revenues.

Imricor Medical Systems has secured Virginia Commonwealth University Health as the third US site for its VISABL-AFL clinical trial, advancing its FDA approval pathway for MRI-guided cardiac ablation technology.

Audeara Ltd reported a strong Q2 FY26 with revenues up 274% year-on-year, securing key regulatory approval in China and expanding its global licensing footprint.

VHM Limited has made significant strides in developing its Goschen Rare Earths and Mineral Sands Project, securing substantial funding and critical regulatory approvals while expanding its resource base.

Bayan Mining reports significantly enhanced rare earth element grades from follow-up surface sampling at its Desert Star Project in California, paving the way for drilling approval and further exploration.

Atomo Diagnostics has locked in exclusive global rights to a novel liver function test that rapidly detects liver injury, expanding its footprint in point-of-care diagnostics. The test, delivered on Atomo’s Pascal platform, targets drug-induced liver injury and chronic liver conditions with significant commercial potential.