Latest Regulatory Approval News

Medical Developments International reports a strong FY25 with significant margin gains and strategic progress, setting the stage for accelerated Penthrox expansion in FY26.

Downer EDI reports a robust FY25 with statutory profit soaring 82% and announces a $230 million share buy-back, signaling confidence in its ongoing transformation.

Telix Pharmaceuticals reported a robust 63% increase in revenue to $390.4 million for the first half of 2025, driven by strong Illuccix sales and the acquisition of RLS Radiopharmacies. Despite this growth, the company recorded a net loss of $2.3 million, reflecting increased investments and finance costs.

Janus Electric has inked a $5 million Memorandum of Understanding with EVUNI to distribute its electric drivetrain technology across Africa, marking a bold step in its international growth strategy.

Octava Minerals reports impressive initial bioleaching recoveries of critical rare earth elements and lithium from its Byro Project, highlighting a promising, low-cost extraction pathway.

Artrya Limited reported a 17.2% increase in net loss to $16.4 million for FY25, while achieving FDA clearance and launching its AI-driven Salix platform in the U.S. market. The company also secured key commercial partnerships in Australia and raised $20 million in equity funding.

Astron Corporation Limited is set to redomicile from Hong Kong to Australia through a scheme of arrangement, creating a new Australian parent company, Aus NewCo. This move aims to align the corporate structure with its Australian assets and simplify shareholder voting.

Xstate Resources has received pre-approval to acquire a 51% stake in the Diona project, setting the stage for drilling operations and ASX trading resumption by late September.

Iris Cairns Property Pty Ltd has increased its cash takeover offer for Reef Casino Trust units to A$3.72 per unit, with the Reef Corporate Services Limited board unanimously recommending acceptance. The offer values the trust at approximately A$185.3 million and awaits regulatory approvals.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

EV Resources has signed a strategic Memorandum of Understanding with Wogen Resources and Xcelsior Capital Advisors to fund and advance its Los Lirios Antimony Project in Mexico, aiming to establish a 100 tonne-per-day processing plant.

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.