Latest Contract Research Organisations News

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Opyl Limited has secured strategic collaborations with two leading contract research organisations, integrating its AI-driven TrialKey platform into cardiovascular, oncology, and rare disease clinical trials to enhance trial design and accelerate commercial growth.

Amplia Therapeutics has completed recruitment early for its Phase 2a ACCENT trial in advanced pancreatic cancer, reporting encouraging interim results and advancing a second trial with FDA-backed protocol changes.

Paradigm Biopharmaceuticals has secured ethics approval and appointed a CRO to launch its global phase 3 trial for injectable Pentosan Polysulfate Sodium in knee osteoarthritis, while initiating a substantial capital raising program.

Zelira Therapeutics has enhanced its financial flexibility through a $1.15 million R&D tax refund and a $1 million At-the-Market equity facility, while progressing FDA trial preparations for its HOPE® 1 autism treatment.

Nyrada has secured ethics approval to begin its first-in-human Phase Ia trial of NYR-BI03, a promising neuro- and cardioprotective drug candidate. Recruitment starts soon, with dosing expected by March and results due in Q3 2025.

Opyl Limited has entered a strategic partnership with Avion, integrating its AI-powered TrialKey platform to enhance clinical trial design and execution across the APAC region.

Cambium Bio has secured a A$3 million capital raise and achieved FDA Fast Track status for its lead ophthalmology product, Elate Ocular®, setting the stage for Phase 3 trials in mid-2025.

Zelira Therapeutics has secured a fourth funding tranche of US$681,000, advancing its HOPE® Autism Spectrum Disorder FDA trial process and bringing total funding to US$3.25 million. The company is progressing clinical validation and product development, including the transformation of Zenivol® into a capsule formulation.

Amplia Therapeutics reports encouraging progress in its Phase 2a ACCENT trial for pancreatic cancer, with nine confirmed partial responses and ongoing patient recruitment. The company also strengthens its financial position with a $13 million capital raise to support further clinical development.

Noxopharm’s December 2024 quarterly report reveals expanding global interest in its Sofra technology through new Material Transfer Agreements and a strengthened cash position following a significant R&D tax rebate.

InhaleRx has corrected its quarterly report and revealed a $38.5 million funding deal to fast-track clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, aiming for FDA approval.