Latest 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.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Patrys Limited is advancing a proprietary injectable formulation of quetiapine aimed at the large and underserved delirium treatment market, leveraging an accelerated FDA approval pathway and extensive existing safety data.

Genetic Signatures is undertaking a major organisational restructure to cut costs by $5 million and sharpen its commercial focus, aiming to accelerate growth in its diagnostic product offerings.

Cynata Therapeutics has completed the 100-day primary evaluation period for its Phase 2 trial of CYP-001 in acute graft versus host disease, with results expected in June 2026. This milestone marks a critical step for the biotech’s lead cell therapy candidate in a condition with few effective treatments.

Recce Pharmaceuticals is progressing its Phase 3 clinical trial of RECCE 327, a novel synthetic antibiotic targeting multidrug-resistant infections, with interim data from Indonesia supporting registration plans across ASEAN by 2026.

Immutep Limited has successfully completed the single ascending dose phase of its IMP761 trial, showing promising safety and immunosuppressive effects in healthy volunteers. The biotech’s novel LAG-3 agonist could reshape autoimmune disease treatment.

Imugene Limited has launched a $20 million equity raising comprising a $12 million placement and an $8 million Share Purchase Plan, alongside issuing options, convertible notes, and warrants to support its azer-cel clinical program.

Arovella Therapeutics has secured TGA confirmation to advance its Phase 1 trial of ALA-101 in Australia via the efficient Clinical Trial Notification pathway, following FDA clearance in the US.

Neurizon Therapeutics announces the resignation of CEO Dr Michael Thurn, with Executive Chair Sergio Duchini stepping in temporarily as the company embarks on a global hunt for new leadership.

Immutep Limited has voluntarily suspended trading of its shares on the ASX pending the release of a key announcement regarding the interim futility analysis of its TACTI-004 Phase III trial. The suspension underscores the market’s anticipation of potentially pivotal clinical trial results.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.