Latest Clinical Development News

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.

Alterity Therapeutics has secured encouraging regulatory feedback from the FDA on its ATH434 Phase 3 program for Multiple System Atrophy, marking a critical step towards pivotal trial initiation.

AdAlta Limited has been granted a key Canadian patent for its anti-fibrotic drug AD-214, completing its composition of matter protection across all major commercial markets. This milestone strengthens the company’s intellectual property portfolio and underpins its commercial strategy for AD-214.

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.

Imricor Medical Systems has filed a Form 10 registration with the U.S. SEC, marking its transition to a U.S. reporting company amid ongoing FDA clearances and clinical trials. This move signals a significant step in its early commercialisation of MRI-guided cardiac ablation technology.

Neurotech International has opened the first clinical site for its pivotal Phase 3 trial of NTI164, targeting core symptoms of Autism Spectrum Disorder in children. This milestone marks a key step toward potential regulatory approval and commercialisation.

Argenica Therapeutics has secured a nearly $4 million R&D tax incentive rebate for FY25, strengthening its cash position as it prepares for a pivotal Phase 2b trial of its neuroprotective peptide ARG-007.

Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.

Dimerix Limited is set to conduct a blinded statistical review of its pivotal Phase 3 ACTION3 study in March 2026, aiming to confirm the trial remains powered to demonstrate the primary endpoint of proteinuria reduction in FSGS patients.

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.

Imugene Limited has launched a $20 million capital raising through a $12 million institutional placement and an $8 million Share Purchase Plan, alongside a convertible notes amendment to support its clinical development pipeline.