Latest Australian Biotech News

Arovella Therapeutics has secured encouraging feedback from the US FDA on reagent testing for its CAR-iNKT cell therapy, setting the stage for an IND filing this quarter and clinical trials in early 2026.

ReNerve Limited reported a 38% increase in quarterly sales driven by the launch of its EmpliQ product range and ongoing development of advanced nerve repair technologies. The company’s cash position remains solid as it prepares for upcoming clinical trials.

BCAL Diagnostics has launched a $10 million convertible note facility, with $5 million already committed, to strengthen its capital position and accelerate commercialisation of its cancer detection technologies.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

BCAL Diagnostics has established a $10 million convertible note facility, with $5 million already committed, to accelerate its cancer detection technologies and commercial milestones.

Starpharma has received a $3.7 million R&D Tax Incentive refund for the 2025 financial year, reinforcing its commitment to advancing dendrimer technology and biotechnology innovation in Australia.

Regal Asian Investments Limited posted a sharp 92% decline in net profit for FY25 amid volatile Asian markets but maintained a fully franked 6 cent dividend and continued its on-market share buy-back program.

Noxopharm Limited has successfully completed the second dose cohort in its HERACLES Phase 1 trial for SOF-SKN™, confirming safety and tolerability and moving forward to a higher dose. This progress marks a key step in developing a novel autoimmune disease treatment.

Invex Therapeutics reports a significantly reduced net loss for FY25, driven by lower R&D costs after closing its Phase III trial, while advancing promising pre-clinical Alzheimer’s research through a collaboration with Tessara Therapeutics.

Vitrafy Life Sciences announces a leadership change with CEO Kate Munnings retiring and co-founder Brent Owens stepping up to lead the company’s next growth phase.

Chimeric Therapeutics has progressed its CHM CDH17 CAR-T cell therapy to dose level 2 in its Phase 1/2 trial, showing promising early anti-tumor activity and a strong safety profile in gastrointestinal and neuroendocrine cancers.