Latest Regulatory Reviews News

BPH Global has clarified the timing and rationale behind its disclosure of a binding Memorandum of Understanding with Indonesia’s National Research and Innovation Agency, confirming compliance with ASX rules.

The US Congress has reauthorized the Rare Pediatric Disease Priority Review Voucher program through September 2029, a move that could significantly benefit Neuren Pharmaceuticals as it advances its rare disease drug candidates.

Resolution Minerals has taken a significant step towards expanding its footprint in the US capital markets by lodging a registration statement with the SEC and launching an ADR facility, while divesting a non-core Alaskan asset to focus on key US projects.

Northern Minerals has made significant strides in developing its Browns Range Heavy Rare Earths Project, securing substantial funding support from US and Australian agencies alongside a $60.5 million capital raise. Exploration success and engineering progress position the company for a Final Investment Decision by late 2026.

Microba Life Sciences reports robust year-on-year growth in microbiome testing volumes and revenue, advancing towards regional break-even in Australia and the UK while progressing its therapeutic pipeline.

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.