Latest Biotech News

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.

Entropy Neurodynamics has received a $1.73 million R&D tax incentive refund from the Australian Government, reinforcing its clinical development of an intravenous psilocin treatment for neuropsychiatric disorders.

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.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals is seeking a re-examination of the European Medicines Agency’s refusal to approve trofinetide for Rett syndrome, aiming to overturn the setback and bring the treatment to European patients.

Chimeric Therapeutics has secured a $1.785 million advance against its anticipated FY26 Research and Development Tax Incentive to bolster its clinical trial pipeline and working capital.

The ASX has suspended trading in eight companies for failing to lodge their periodic reports on time, raising fresh questions about compliance and market confidence.

Avecho Biotechnology reported a 9.3% revenue increase alongside a 41.5% rise in net loss for 2025, while progressing its Phase III CBD insomnia trial and securing a significant licensing agreement with Sandoz.

Clarity Pharmaceuticals has reported a steep 136% increase in its half-year loss to $55.6 million, alongside the closure of its European subsidiary, signaling a challenging period for the ASX-listed biotech.

Paradigm Biopharmaceuticals reports a sharp rise in half-year losses as it intensifies investment in its pivotal Phase 3 trial for knee osteoarthritis, setting sights on a critical interim analysis in mid-2026. The company also expands its osteoarthritis pipeline and maintains strong funding amid a strengthening biotech sector.