Latest Australian Biotech News

Bioxyne Ltd has secured a manufacturing agreement with global cannabis giant Aurora Cannabis, marking a major step in its international expansion of pharmaceutical-grade medicinal cannabis products.

Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.

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.

Noxopharm has successfully completed dosing in its HERACLES clinical trial for SOF-SKN™, demonstrating strong safety and tolerability. The company also secured a new overseas partnership and its first US patent for the Sofra platform.

Noxopharm has successfully completed the final multiple-dose cohort of its HERACLES trial for SOF-SKN™, reporting no significant safety concerns and paving the way for Phase II-enabling studies.

BioMarin Pharmaceutical’s acquisition of Amicus Therapeutics for US$4.8 billion includes Dimerix’s US licensing agreement, promising significant milestone payments and royalties. This deal strengthens Dimerix’s position as it advances its Phase 3 kidney disease therapy.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Chimeric Therapeutics has received a $4.5 million R&D tax incentive refund from the Australian Government, underscoring its ongoing investment in innovative cancer cell therapies.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Noxopharm Limited reports growing interest in its Sofra technology with new research collaborations and a safe, well-tolerated HERACLES trial of SOF-SKN. The company also secures funding extensions to support ongoing development.

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.