Latest Regulatory Reviews News

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

Viridis Mining and Minerals reports strong infill and exploration drilling results at its Colossus Rare Earth Element Project, underpinning a resource upgrade and enhanced project economics. The company advances feasibility, permitting, and financing towards a Final Investment Decision in Q3 2026.

Aurizon Holdings reported a 9% rise in underlying EBITDA to $891 million for the half-year ending December 2025, driven by higher volumes and yields in coal and bulk segments. The company also raised its full-year dividend guidance and extended its share buy-back program.

Sarytogan Graphite Limited has upgraded its Mineral Resource Estimate to include 5.4 million tonnes of Measured graphite, underpinning a multi-decade mine life in Kazakhstan. This milestone supports the ongoing Definitive Feasibility Study due mid-2026.

The a2 Milk Company has reported robust half-year results with strong revenue and earnings growth, driven by gains in infant formula and liquid milk segments, alongside a strategic supply chain transformation. The company has upgraded its full-year outlook and announced a substantial special dividend, signalling confidence in its growth trajectory.

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.