Latest Clinical Trials News

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

EBR Systems has achieved a major commercial milestone with Medicare reimbursement approvals for its wireless cardiac pacing WiSE CRT System, driving a 201% revenue increase in Q3 2025. The company is advancing its Limited Market Release as it scales adoption in the US.

Immutep Limited’s Phase II EFTISARC-NEO trial reveals a novel immunotherapy combo delivering a striking 51.5% tumour response in soft tissue sarcoma patients, alongside robust immune activation signals.

Actinogen Medical’s XanaMIA Phase 2b/3 trial for Alzheimer’s disease has received a positive safety recommendation from its independent Data Monitoring Committee, allowing the study to proceed unchanged. Investors now await the critical efficacy analysis scheduled for January 2026.

Neurotech International has received a $4.73 million R&D tax incentive refund, reinforcing its clinical development efforts in paediatric neurological disorders. The funds will support ongoing trials and working capital needs.

Proteomics International Laboratories has secured a $2.2 million Australian Government R&D tax rebate, reinforcing its financial position as it advances a promising pipeline of diagnostic tests based on its proprietary Promarker® technology.

Pathkey.AI has teamed up with Armstrong Clinical to blend AI-driven trial predictions with expert clinical strategy, aiming to boost early-phase trial success and accelerate drug development in Australia and beyond.

NeuroScientific Biopharmaceuticals has initiated treatment of its fourth patient under the Special Access Scheme for StemSmart™, progressing towards a Phase 2 trial targeting severe Crohn’s disease.

Invex Therapeutics Ltd has had its trading suspension lifted following an announcement of new board and officer appointments, signaling a fresh chapter for the biotech company.

Chimeric Therapeutics has responded to ASX inquiries regarding the disclosure timing and materiality of new clinical data from its ADVENT-AML trial, emphasizing compliance with continuous disclosure rules and the careful verification of promising patient responses.

Immuron Limited has secured FDA approval for its IMM-529 Investigational New Drug application, clearing the way for a Phase 2 clinical trial targeting Clostridioides difficile infection. This milestone marks a significant step forward for a novel oral antibody therapy addressing a critical infectious disease with high recurrence rates.