Latest Regulatory Clearance News

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

National Storage REIT delivered robust half-year results with earnings and occupancy gains, while agreeing to a premium acquisition offer from Brookfield-GIC consortium.

SGH Limited has announced a fully franked ordinary dividend of AUD 0.32 per share for the six months ending December 2025, signalling steady returns for shareholders.

Memphasys Limited has secured Therapeutic Goods Administration approval for its Felix™ System two months ahead of schedule, enabling immediate commercial sales and clinical use in Australia.

Aurora Energy Metals updates investors on its strategic option agreement with Eagle Energy Metals, which is set to become the first US-listed uranium explorer with SMR technology following a pending SPAC merger.

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Aura Consolidated Group and Qoria Limited have announced a merger to create AXQ, a global leader in digital safety and cybersecurity, backed by a US$75 million equity raise and targeting strong growth and innovation.

FireFly Metals has agreed to sell its Ontario gold assets to Bellavista Resources for up to A$86.1 million in shares and performance rights, unlocking value for shareholders while focusing on its copper-gold growth strategy.

FireFly Metals has agreed to sell its Ontario gold assets, including a 70% stake in the Pickle Crow Project, to Bellavista Resources for up to A$86.1 million in scrip. FireFly shareholders will receive Bellavista shares, maintaining exposure to the assets while FireFly focuses on its copper-gold ambitions.

Global Uranium and Snow Lake Resources have agreed to a binding merger scheme, with Snow Lake acquiring all remaining shares of Global Uranium. This follows a major drilling success at the Pine Ridge Uranium Project and regulatory approvals that pave the way for a combined uranium-focused entity.

Toro Energy shareholders are set to gain exposure to a diversified uranium portfolio through IsoEnergy’s acquisition offer at a near 80% premium, while Toro advances its Wiluna Uranium Project amid strong market tailwinds.

Echelon Resources reported a slight dip in production but secured long-term gas sales contracts extending to 2034 and plans four new development wells in the Amadeus Basin. The company also reduced its debt by A$7 million, maintaining financial flexibility for growth.