Latest Regulatory Approvals News

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.

BetMakers Technology Group launches a $13.5 million equity raise to fund the acquisition of Las Vegas Dissemination Company and strengthen its financial position amid improving operational metrics.

Mayne Pharma disputes Cosette Pharmaceuticals’ attempt to terminate their acquisition agreement, with a key court hearing postponed to September and a crucial shareholder vote set for June 18.

Lotus Resources has secured Environmental and Social Impact Assessment approval for its Kayelekera Uranium Project in Malawi, paving the way for uranium production to resume in the third quarter of 2025. The company also completed a key board transition, signaling a new phase in its governance.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

NH3 Clean Energy has signed a non-binding MoU with the Angel CCS Project JV to collaborate on carbon capture and sequestration for its WAH2 clean ammonia project, marking a key step toward its mid-2025 FEED entry.

Marimaca Copper Corp. has announced a US$17.7 million private placement led by existing insiders and a new institutional investor to fund exploration and development of its flagship copper project in Chile.

Empire Energy Group has launched a $28 million equity raise to finance critical development activities in the Beetaloo Basin, targeting first gas sales from its Carpentaria Pilot Project in 2025. The capital raise, combined with a $65 million financing package, underpins the company’s ambition to commercialize one of Australia’s largest low-CO2 shale gas resources.

Spartan Resources Limited shareholders are set to vote on a scheme of arrangement for Ramelius Resources Limited to acquire all Spartan shares, creating a leading Australian gold producer with a pro forma market capitalization of $5.3 billion.

OncoSil Medical has launched a Security Purchase Plan offering discounted shares and free options to eligible shareholders, aiming to accelerate commercialization of its pancreatic cancer treatment device.

National Storage REIT has partnered with GIC to invest $228 million in a second tranche of self-storage development assets, reaffirming its FY25 earnings guidance and strategic growth plans.

Chimeric Therapeutics has secured FDA Fast Track designation for its CHM CDH17 CAR-T therapy targeting gastroenteropancreatic neuroendocrine tumours, accelerating its path toward regulatory approval and patient access.