Latest Regulatory Review News

Argenica Therapeutics has passed a critical FDA genotoxicity test for its stroke drug ARG-007, advancing its IND application and edging closer to Phase 2b clinical trials in the US and Australia.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

The Australian Treasurer has mandated the disposal of over 1.6 billion shares held by foreign entities in Northern Minerals, intensifying regulatory scrutiny of foreign ownership in this critical rare earths company.

Singapore’s telecom regulator has paused its assessment of Tuas Limited’s acquisition of M1 Limited amid concerns over unauthorized spectrum use by Simba, a related entity. This regulatory hurdle casts uncertainty on the transaction’s imminent completion.

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

CurveBeam AI reported stable device orders but faces regulatory delays for FDA and China clearances, while securing a A$4 million investment from WEGO Orthopaedics and advancing clinical collaborations with robotic surgery systems.

Rakon Limited has swung back to profit in FY26, reporting a 24% revenue lift and doubling EBITDA, while Bourns' takeover offer edges closer to completion with 85% shareholder acceptance and pending French regulatory approval.

Equatorial Resources has completed its final arbitration submissions against the Republic of Congo with a final ICSID award expected in the first half of 2027. Meanwhile, the company continues to seek clarity on the status of its iron ore exploration permits in Guinea amid ongoing regulatory uncertainty.

Siren Gold continues its push to upgrade the Sams Creek gold resource with ongoing drilling and a mining permit application nearing decision. Meanwhile, exploration at Queen Charlotte reveals extensive high-grade gold and antimony mineralisation, underpinning the company’s strategic growth in New Zealand’s critical minerals sector.

Ampol has increased its divestment offer to the ACCC by four additional sites, raising the total to 41 as it pushes to satisfy competition concerns in its EG Australia acquisition. The move aims to secure regulatory clearance ahead of a mid-2026 transaction close.

Recce Pharmaceuticals has cleared a critical regulatory hurdle in Indonesia with a successful inspection of its Phase 3 clinical trial site for diabetic foot infections, paving the way for potential approval in 2026 amid a large and growing market.

Rua Gold has lodged a Fast-Track Referral application for its Auld Creek gold and antimony project in New Zealand's Reefton Goldfield, aiming to speed up permitting and development under new government legislation.