Latest Regulatory Milestones News

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Neurotech International has received a $4.73 million R&D tax incentive refund, reinforcing its clinical development efforts in paediatric neurological disorders. The funds will support ongoing trials and working capital needs.

Marimaca Copper's Chilean subsidiary has obtained formal environmental approval for its Marimaca Oxide Project, clearing a critical hurdle toward construction readiness in the second half of 2026. This milestone follows years of environmental and social groundwork and sets the stage for the next permitting phase.

MA Financial Group advances exclusive due diligence on a major Queensland retail asset and prepares a new ASX-listed credit notes offer, signaling strategic growth moves.

Memphasys Limited has successfully raised over $1.1 million through a pro-rata entitlement offer to accelerate the commercialisation of its innovative Felix™ sperm selection system, targeting key regulatory approvals and market expansion.

Mandrake Resources has signed a term sheet with DISA Technologies to explore recovering uranium and critical minerals from abandoned mine waste in Utah, leveraging a unique US regulatory license and strong government backing.

GoviEx Uranium has received the Supreme Court of British Columbia's final approval for its reverse takeover of Tombador Iron, setting the stage for completion by mid-November 2025.

AVITA Medical reported a 13% drop in Q3 commercial revenue to $17.1 million but improved its net loss and secured CE Mark approval for RECELL GO in Europe, signaling strategic shifts ahead.

Neuren Pharmaceuticals reported a milestone quarter with DAYBUE net sales reaching US$101.1 million, driving a 24% jump in royalty income. The expanding patient base and community physician uptake signal strong growth ahead.

Immuron Limited has secured FDA approval for its IMM-529 Investigational New Drug application, clearing the way for a Phase 2 clinical trial targeting Clostridioides difficile infection. This milestone marks a significant step forward for a novel oral antibody therapy addressing a critical infectious disease with high recurrence rates.

Santana Minerals has been granted a 30-year mining permit for its Bendigo-Ophir Gold Project in Central Otago, surpassing earlier expectations of a 25-year term and providing long-term operational certainty.

Santana Minerals has been granted a crucial 25-year mining permit for its Bendigo-Ophir Gold Project in New Zealand, paving the way for construction and gold production pending environmental approvals.