Latest Regulatory Review News

The Australian Competition and Consumer Commission has advanced its review of Ampol’s acquisition of EG Australia to a more detailed Phase 2 assessment, signalling potential competition concerns. Ampol remains optimistic about completing the deal by mid-2026 despite the regulatory scrutiny.

The ACCC has referred Ampol’s acquisition of EG Australia to a detailed Phase 2 review, citing significant competition concerns in multiple Australian fuel markets. Ampol’s proposed divestments have so far failed to satisfy the regulator.

The ACCC has referred Ampol’s acquisition of EG Australia to a detailed Phase 2 review, citing concerns that the deal could significantly reduce competition in key Australian fuel markets.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

The Foreign Investment Review Board has extended its deadline to assess Caterpillar’s proposed acquisition of RPMGlobal, pushing the decision to 23 January 2026. This procedural extension keeps the deal on track but leaves some questions open for shareholders.

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

New Frontier Minerals has moved its Mining Lease Application for the Big One Copper Deposit into the technical assessment phase, marking a key step toward near-term development amid a strong copper market.

Dart Mining NL reports encouraging 2024 diamond drilling results at its Rushworth project in Victoria, revealing multiple wide gold mineralised lodes at the Phoenix Reef prospect. The company plans to resume drilling in 2026, targeting new structural zones identified by recent interpretations.

Neurizon Therapeutics has locked in a $44 million funding package to fully support its lead drug NUZ-001 in the HEALEY ALS Platform Trial, marking a critical step toward potential regulatory approval and broader neurodegenerative applications.

Aurizon has lodged a proposed ten-year Network Access Undertaking with the Queensland Competition Authority, aiming to secure long-term certainty and enhanced operational incentives for the Central Queensland Coal Network.

Telix Pharmaceuticals reports positive Phase 3 results for its prostate cancer imaging agent Illuccix in China, paving the way for a near-term regulatory submission. Meanwhile, the company advances FDA resubmissions for its glioma and kidney cancer imaging candidates.