Latest Regulatory Approval News

Alterity Therapeutics has clinched FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy, with the trial set to begin by the end of 2026.

Lakes Blue Energy reports promising pressure build-up and confirms extensive gas-bearing sands at Wombat-5, targeting enhanced perforation and flow testing in late August 2026.

Mont Royal Resources has unveiled an updated Preliminary Economic Assessment for its Ashram Rare Earths Project, confirming robust economics and a long mine life with strategic importance for Western critical minerals supply chains.

Raiden Resources has struck a binding deal with Forgent PLC to potentially sell an 80% stake in its Mt Sholl nickel-copper-PGE project, while retaining a 20% free-carried interest. The transaction could inject over A$1 million in cash and shares, aligning with Raiden’s strategy to streamline its portfolio and focus on core assets.

Helix Resources highlights unresolved legal and procedural issues in the Gold Basin-CANEX arrangement despite shareholder approval, underscoring ongoing court scrutiny and contested joint venture validity.

Maritana Minerals has increased the processing capacity of its Black Swan Processing Hub to 2.5 million tonnes per annum, with construction set to begin mid-2026 and first production expected in the second half of 2027.

Bounty Oil & Gas NL has issued a prospectus offering over 632 million new options to eligible investors as part of a broader recapitalisation, potentially raising $6.3 million if exercised.

Brazilian Rare Earths Limited (BRE) is demerging its Amargosa Bauxite-Gallium Project into Alurion Resources, with eligible shareholders receiving in-specie shares and access to a $30-50 million IPO.

Almonty Industries has announced a $700 million convertible senior notes offering due 2031, aiming to refinance existing debt and fund corporate initiatives amid rising tungsten demand.

TMK Energy reports a steady increase in gas output and launches a 1MW Gas to Power pilot in Mongolia, aiming to boost well performance and secure a production license.

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.

Optiscan Imaging has reached the halfway recruitment milestone in its first in-human breast cancer study, advancing its regulatory and commercial ambitions with promising clinical data and expanded trial sites.