Latest Regulatory Approvals News

Radiopharm says the FDA has provided a clear framework for the pivotal development of RAD101, its investigational brain metastases imaging agent. The company is preparing for Phase 3 while awaiting formal meeting minutes that could still refine the trial design and regulatory requirements.

Famien Resources will sell its West Yilgarn exploration portfolio to Voltaic Strategic Resources for $330,000 upfront, with a further $2 million tied to future gold resource milestones. The deal gives Famien immediate cash while leaving the larger deferred payment dependent on exploration success by the buyer.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

HealthCo Healthcare and Wellness REIT has signed binding agreements for new leases covering its remaining 10 Healthscope hospitals, subject to final approvals. The resolution allows HCW to reinstate quarterly distributions while reducing its largest tenant concentration from 57% to 31%.

Buru Energy has formally referred its 100%-owned Rafael Conventional Gas Project to Western Australia’s environmental regulator, with a decision on whether the project requires assessment expected by late 2026. The referral keeps the company’s targets of a final investment decision in the second half of 2027 and first gas in early 2029 in view, subject to approvals.

Gold Mountain has secured a 12-month exclusive right to acquire the historical Malhada do Angico tungsten mine in northeast Brazil, for staged consideration of up to R$3 million. The opportunity comes with encouraging but non-representative grab samples, pending approvals and a drilling program still awaiting permits.

Centaurus Metals has signed the contract securing initial 20MW of 230kV grid power for its Jaguar nickel project in Brazil. The infrastructure milestone removes one development hurdle, while funding negotiations and final connection approvals remain outstanding.

Capstone Copper has agreed to sell its Cozamin mine in Mexico to Luca Mining in a deal featuring US$275 million upfront and as much as US$110 million in deferred and copper-linked payments. The proposed sale would give Capstone fresh balance-sheet capacity while preserving indirect exposure to the asset through Luca shares.

Port of Tauranga’s Stella Passage development has been hit by an appeal and a judicial review application from tangata whenua parties. The port says the project remains urgent and will seek the earliest possible court hearing, but has disclosed no estimate of the legal or financial impact.

Klevo Group has reported a sharp FY2026 turnaround, with revenue up 324%, positive operating cash flow and cash rising to A$4.32 million. The more striking claim is its KLVR stablecoin platform, which has recorded USD 59.2 million in unaudited revenue since trial commencement ahead of a planned commercial rollout.

Lynas Rare Earths has agreed to acquire Meteoric Resources in an all-share deal valued at about A$968 million, adding the Caldeira rare earths project in Brazil to its portfolio. The proposed transaction would materially expand Lynas’ resource base, but still depends on shareholder, court and Brazilian regulatory approvals.

Oregon Group is seeking effective control of New Zealand King Salmon after agreeing to buy half of a 9.87% stake and secure voting rights over another holder’s shares. The proposed transaction would give Oregon control of 50.68% of NZK’s voting rights, subject to several approvals.