Latest Regulatory Engagement News

Acrux pivots from generics to developing a Female Testosterone therapy for HSDD, leveraging FDA feedback and a strong US market opportunity.

Amplia Therapeutics reported mature ACCENT trial data showing improved survival and multiple complete responses with narmafotinib, alongside a GMP production milestone and CFO appointment.

PYC Therapeutics fortified its balance sheet by $600 million and progressed key RNA therapeutic trials in Q1 2026, setting the stage for pivotal clinical data and regulatory submissions.

Ardiden Limited has secured the historic Golden Patricia Gold Mine from Barrick, consolidating a high-grade gold corridor in Ontario’s Pickle Lake district and opening significant exploration opportunities.

Alterity Therapeutics has secured FDA alignment on the chemistry and manufacturing controls for its ATH434 Phase 3 trial in Multiple System Atrophy, marking a pivotal regulatory milestone ahead of the planned mid-2026 End-of-Phase 2 meeting.

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.