Latest Clinical Trials News

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

PolyNovo’s NovoSorb BTM technology has demonstrated promising first-in-human results as a novel delivery platform for pancreatic islet cell transplants in Type 1 diabetes, potentially redefining treatment approaches.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Radiopharm Theranostics has secured Data Safety and Monitoring Committee approval to escalate dosing in its Phase 1 trial of 177Lu-RAD204, expanding patient cohorts across multiple cancer types.

Neuren Pharmaceuticals reports a robust 11% rise in DAYBUE™ US net sales for Q1 2025, alongside a 17% jump in royalty income, setting the stage for an anticipated European market entry in early 2026.

Algorae Pharmaceuticals has partnered with Peter MacCallum Cancer Centre to validate AI-predicted drug combinations across multiple cancer types, aiming to accelerate its oncology pipeline development.

Nyrada’s experimental drug NYR-BI03 shows promising cardioprotective and anti-arrhythmic effects in animal models, reinforcing its potential as a treatment for acute myocardial infarction.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.

Dimerix has received a US$30 million upfront payment from Amicus Therapeutics for exclusive US rights to DMX-200, a promising kidney disease therapy. The deal positions Dimerix for up to US$560 million in further milestones plus royalties, underpinning its global licensing strategy.