Latest Regulatory Approvals News

Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.

NRW Holdings’ subsidiary Primero Group has landed a $157 million contract from Rio Tinto to deliver critical infrastructure at Hope Downs in Western Australia, extending their longstanding partnership.

CZR Resources has won overwhelming shareholder approval to sell its Robe Mesa Iron Ore Project to a Rio Tinto-Mitsui joint venture for approximately A$75 million, setting the stage for a significant portfolio reshuffle.

TruScreen Group Limited has launched a NZ$1.22 million Share Purchase Plan offering discounted shares to eligible investors, aiming to fuel growth in key international markets and public health initiatives.

TruScreen Group Limited has announced a NZ$3 million capital raise to fund strategic growth initiatives across Asia and Africa, alongside repaying existing debt. The raise includes a placement and share purchase plan with free attaching options, signaling confidence in its expanding cervical cancer screening programs.

Uvre has cleared a crucial regulatory hurdle in its acquisition of New Zealand’s Waitekauri Gold Project, setting the stage for new leadership and exploration activities.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

Agrimin Limited has initiated a strategic review of its flagship Mackay Potash Project following prolonged approvals and market challenges, while spotlighting its valuable stakes in WA1 Resources and an upcoming Tali Resources IPO.

Felix Gold Limited has confirmed its ability to produce premium-grade antimony concentrate with up to 69% purity from its Treasure Creek Project in Alaska, targeting production by late 2025. The results align with U.S. strategic mineral priorities amid a tightening global supply.

Red Sky Energy has partnered with Condor Energy and associates to fund the drilling of the KN2 well at Killanoola, targeting a promising new reservoir zone identified by advanced seismic data. This move aims to boost production and accelerate cash flow from the South Australian oil project.

Estrella Resources has initiated Timor-Leste’s inaugural modern metallic minerals drilling campaign, targeting manganese at the Ira Miri Prospect. This milestone marks a new chapter in the country’s mineral exploration history.

Aroa Biosurgery has reported FY25 results that exceed revenue guidance and deliver a positive normalised EBITDA, setting the stage for ambitious growth and reimbursement expansion in FY26.