Latest Australian Biotech News

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.

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.