Latest Regulatory Engagement News

Mount Hope Mining has engaged R.W. Corkery & Co to lead environmental baseline studies and prepare for an Environmental Impact Statement at its Mt Solitary gold project, a crucial step towards mining approvals in NSW.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

Imugene’s off-the-shelf CAR T therapy azer-cel has won FDA Fast Track Designation for relapsed or refractory CLL/SLL and MZL, backed by compelling Phase 1b response rates.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Vitrafy Life Sciences has teamed up with Vitalant Innovation Center to tackle the impending gap in red blood cell cryopreservation technology in the US, aiming to replace soon-to-be-discontinued legacy methods and potentially expand into other blood products.

The Therapeutic Goods Administration has broadened the range of clinicians eligible to participate in psychedelic-assisted psychotherapy, a move set to speed up recruitment and improve patient access across Emyria’s national Empax network.

Imugene has dosed the first patient in a new cohort combining its azer-cel CAR T therapy with BTK inhibitors, targeting patients with B-cell malignancies who failed prior BTKi treatment. This move broadens the trial’s scope and tackles a significant unmet need in blood cancer therapy.

Viridis Mining has produced its first batch of high-grade Mixed Rare Earth Carbonate at its Poços de Caldas Demonstration Plant, advancing key milestones for the Colossus Project and setting the stage for commercial-scale rare earth production.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

Macquarie Group (ASX: MQG) reported a 30% jump in FY2026 net profit to A$4.85 billion, driven by growth across all divisions and bolstered by strategic investments in AI and sustainability. The board declared a total dividend of A$7 per share and maintained a strong capital position amid ongoing regulatory remediation.

PEXA Group delivered a 7.3% rise in Australian property transaction volumes in 3Q26 and saw steady UK remortgage growth despite macroeconomic uncertainty. The company reaffirmed its FY26 guidance, aiming for NPAT at the top of its $15m-$25m range.

Ardea Resources’ Kalgoorlie Nickel Project’s Goongarrie Hub has been named in the Australia-Japan joint statement on critical minerals cooperation, highlighting its role in securing resilient nickel-cobalt supply chains backed by government support.