Latest Regulatory Engagement News

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.

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

Cynata Therapeutics has secured A$1.5 million through an institutional placement priced at a 22.5% discount, aiming to extend its cash runway ahead of pivotal Phase 3 and Phase 2 trial results expected in May and June 2026.

TrivarX has made significant strides in preparing its Stabl-Im stable isotope imaging platform for Phase 1 clinical trials, backed by strengthened leadership and a solid cash reserve of $2.91 million.

TrivarX appoints Dr Danielle Meyrick as CEO to spearhead clinical trials and commercialisation of its novel stable isotope MRI brain cancer imaging platform, with Phase 1 studies on track for completion this year.

AdAlta has secured Australian manufacturing for its lead CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients. This move is a key step toward local clinical trials and boosts the therapy’s global commercial appeal.

Argenica Therapeutics is progressing its ARG-007 drug toward a targeted Phase 2b trial for acute ischaemic stroke, leveraging AI for patient selection and securing key regulatory approvals, while maintaining a solid cash position of $8 million.