Latest Regulatory Pathways News

Monash University has secured a $799,866 Australian Research Council grant to study brain injury thresholds using HITIQ’s PROTEQT™ instrumented mouthguards, with a $200,000 pre-order confirming commercial momentum.

Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.

Far East Gold has secured a pivotal PIPPIB approval for 9,000 hectares of its Idenburg Gold Project in Papua, Indonesia, clearing a major regulatory hurdle and accelerating its path toward mine development.

TrivarX Limited has exercised its option to acquire the innovative Stabl-Im brain imaging technology, aiming to revolutionize early detection of brain tumours pending shareholder approval.

Anteris Technologies has secured FDA approval to commence its pivotal PARADIGM clinical trial, testing its innovative DurAVR Transcatheter Heart Valve against established devices in patients with severe aortic stenosis.

Santana Minerals has lodged a comprehensive Fast-track Approvals application for its Bendigo-Ophir Gold Project in New Zealand, aiming for development consents by the end of the 2026 financial year. The project promises significant economic and employment benefits for the Central Otago region.

InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.

Superior Resources has boosted its Greenvale Project area by 56%, revealing exceptional copper-gold-silver assay results and advancing its Steam Engine Gold Project towards production within two years.

Alterity Therapeutics reports strengthened efficacy signals for ATH434 in Multiple System Atrophy and secures a robust cash position to fuel upcoming Phase 3 trials.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

Vectus Biosystems has signed a binding agreement to sell its VB4-P5 renal fibrosis compound to Canadian biotech XORTX Therapeutics, while actively pursuing licensing opportunities for its lead drug VB0004 and others, particularly in China.

Biotron Limited has advanced its Hepatitis B antiviral program while preparing to acquire Sedarex Limited, backed by a $2.5 million capital raise. The move signals a strategic expansion into safer anaesthetics alongside ongoing R&D progress.