Latest Regulatory Engagement News

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

American Rare Earths is fast-tracking its Wyoming Halleck Creek rare earths project, defining a pilot plant pathway, advancing oxide to metal studies, and targeting a NASDAQ listing by year-end 2026.

Qoria Limited has increased its equity placement to US$100 million, backed by insiders, to support aggressive AI investment and integration with Aura. The combined group reports robust ARR growth and reiterates FY26 guidance amid ongoing merger preparations.

Alterity Therapeutics has unveiled fresh Phase 2 data revealing ATH434’s ability to slow functional decline in Multiple System Atrophy patients, measured by the novel MuSyCA scale. This reinforces the drug’s disease-modifying potential ahead of pivotal Phase 3 trials.

Bank of Queensland’s statutory profit fell 20% to $136 million in 1H26, weighed down by a $31 million loss on its equipment finance portfolio sale. The bank advances its digital transformation and plans a $3.7 billion capital release with Challenger Limited, maintaining strong capital and dividend guidance.

Magnetic Resource NL has submitted an updated Mining Proposal for its Lady Julie Gold Project, incorporating a revised tailings strategy and enhanced technical studies, as it continues to engage with regulators ahead of development.

Patrys has raised A$3.2 million through a share placement to fund its injectable quetiapine program’s Phase 1A clinical trial and FDA pre-IND preparations.

Critical Resources has defined a focused 2026 exploration program at its Mavis Lake lithium project while confirming an orogenic gold system in New Zealand and delivering promising early results from its solid-state lithium-ion battery evaluation.

Santana Minerals has finalised the second tranche of its A$130 million capital raising, issuing nearly 19 million shares and securing A$17.04 million before costs. The company confirms ongoing progress towards project construction scheduled for late 2026, supported by strong margins and green hydro power.

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.

Native Mineral Resources has successfully poured 560 ounces of gold doré at its Blackjack plant and is on track to begin mining at Podosky in April, advancing multiple projects in Queensland.

Brazilian Rare Earths Limited has secured a key Trial Mining Licence for its Monte Alto project, marking a significant step toward commercial rare earths production in Brazil.