Latest Regulatory Approval News

Lumos Diagnostics has locked in a A$5 million secured loan facility to support working capital as it advances toward FDA CLIA waiver for its FebriDx® test, complementing a landmark US distribution deal.

Clarity Pharmaceuticals has successfully completed recruitment for its pivotal Co-PSMA Phase II trial, testing its novel Cu-SAR-bisPSMA diagnostic against the current standard in detecting prostate cancer recurrence. This milestone advances their mission to improve early detection and treatment outcomes for men with low PSA levels.

Locksley Resources has confirmed multiple new mineralised trends at its Mojave Critical Minerals Project in California, setting the stage for an expanded drilling campaign in Q3 2025. The company’s detailed structural mapping and 3D geological modelling have refined exploration targets for antimony and rare earth elements, aligning with growing US strategic interests in domestic critical minerals.

Ionic Rare Earths’ Brazilian joint venture Viridion has secured land and government backing to build South America’s inaugural rare earth refining and recycling centre, aiming to start operations by late 2026.

Immuron Limited reports a robust 49% increase in FY25 global sales of its immune supplement Travelan, driven by strong growth in Australia and North America. The company plans to accelerate its North American market presence in FY26.

Buru Energy revises its Rafael Gas Project development plan, prioritising drilling the Rafael B appraisal well in mid-2026 and delaying the Final Investment Decision by six months, while maintaining first production for late 2027.

Great Boulder Resources has released a scoping study for its Ironbark deposit within the Side Well Gold Project, highlighting a high-grade 100,000 oz resource and strong financial metrics that underpin a promising mining opportunity near Meekatharra, WA.

betr Entertainment Limited has launched an all-scrip takeover bid for PointsBet Holdings Limited, offering 3.81 betr shares for every PointsBet share, valuing PointsBet at $1.22 per share and promising significant cost synergies.

Imugene Limited has launched a $37.5 million equity raising through a Placement and Share Purchase Plan, offering new shares and options to fund its pivotal azer-cel clinical program. The raise includes attaching and piggyback options, subject to shareholder approval, aiming to bolster the company’s immuno-oncology pipeline.

Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.

Evolution Mining has delivered record cash flow for FY25, meeting its original production and cost guidance amid high metal prices, while setting a confident outlook for FY26 with continued strong cash generation expected.

Mount Gibson Iron Limited is set to acquire a 50% stake in the Central Tanami Gold Project from Northern Star Resources for $50 million, marking its strategic entry into the precious metals sector. The project boasts a substantial 1.6 million ounce gold resource and significant infrastructure, positioning MGX for potential development within 18 months.