Latest Clinical Trials News

Alterity Therapeutics has unveiled encouraging Phase 2 trial results for ATH434, demonstrating its potential to slow disease progression in Multiple System Atrophy while maintaining a strong safety profile.

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

Actinogen Medical has reached a pivotal agreement with the US FDA outlining the regulatory and clinical trial requirements for Xanamem’s approval in Alzheimer’s disease, setting a clear path toward a US marketing application.

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

PolyNovo’s NovoSorb BTM, combined with negative pressure wound therapy, significantly accelerates healing of large post-surgical diabetic foot wounds, according to new clinical trial data.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Pathkey.AI’s TrialKey platform has demonstrated a 73% alignment with actual biotech trial outcomes, showing an average hypothetical share price gain of 76%, underscoring AI’s growing role in clinical trial prediction and biotech investing.

PYC Therapeutics has completed dosing in its Phase 1 study of PYC-001 for Autosomal Dominant Optic Atrophy, showing strong safety and early signs of improved vision. The company plans to launch a global Phase 1/2 trial later this year.

Control Bionics Limited has announced a 1-for-5 non-renounceable rights issue to raise up to $2.06 million, aiming to fund the commercial expansion of its NeuroStrip® device and operational growth. The offer is partially underwritten and open to eligible shareholders in Australia and New Zealand.

Amplia Therapeutics has commenced dosing the first patient in its new pancreatic cancer trial combining narmafotinib with FOLFIRINOX chemotherapy, marking a key milestone in its drug development journey.