Latest Regulatory News

Immutep’s INSIGHT-003 trial shows promising overall survival in first-line non-squamous NSCLC, yet the Phase III TACTI-004 trial was discontinued following a futility analysis. Ongoing root cause investigations aim to clarify the divergent outcomes.

Klevo Rewards has successfully completed a 14-day commercial trial of its stablecoin transaction platform, generating approximately USD 1.22 million in gross revenue and validating its payment capabilities.

Australian Oil Company (ASX:AOK) is ramping up activity in Queensland's Surat Basin, engaging Energetica Consulting for independent resource assessments and pushing production restarts at Emu Apple and Riverslea fields.

Magnum Mining has secured Jack Lifton, a globally recognised rare earth expert, to steer business development as it advances its Piracanjuba North drilling campaign in Brazil.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Count Limited has received Australian Competition and Consumer Commission clearance for its Oracle Group acquisition and locked in a $116.6 million debt facility with Commonwealth Bank to fund the deal and support growth.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Vault Minerals is set to terminate its scheme implementation deed with Regis Resources following Regis's decision not to match a superior offer from Genesis Minerals. Vault will pay a $50.7 million break fee to Regis as it moves to finalise the Genesis acquisition.

The U.S. Department of Justice has reinforced Dateline Resources' legal standing to continue mining at the Colosseum Project, opposing environmental group claims that challenge the existing Plan of Operations.

OncoSil Medical has completed key manufacturing validation cycles with Cyclotek, paving the way for scalable Australian production of its OncoSil™ device. With a $2.1 million capital investment, the company aims to boost margins and supply chain control ahead of commercial launch in late 2026.

Sky Metals has unveiled a significant Mineral Resource Estimate upgrade for its Tallebung project, lifting tin and tungsten inventories substantially and introducing a maiden silver resource. This positions Tallebung as a large-scale, shallow open-pit opportunity with promising metallurgical and development prospects.

CLINUVEL Pharmaceuticals secures Canadian marketing approval for SCENESSE®, expanding access to the only approved systemic photoprotective treatment for erythropoietic protoporphyria (EPP).