Latest Clinical Trials News

Nyrada Inc. has released compelling preclinical data showing its drug candidate Xolatryp protects mitochondrial function by reducing calcium overload in brain injury models, bolstering confidence ahead of its Phase IIa trial in acute myocardial infarction.

Race Oncology has uncovered that its anticancer drug bisantrene exists as three light-sensitive isomers, with only one showing potent activity. The company has filed patents to protect this active form, potentially extending its intellectual property rights until 2045.

CSL Limited has partnered with Dutch biotech VarmX to develop VMX-C001, a novel treatment aimed at reversing bleeding in patients on FXa inhibitors, with FDA Fast Track status and a potential 2029 launch.

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.