Latest Pharmacokinetics News

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

Neurotech International has secured FDA clearance for its NTI164 Investigational New Drug application and obtained Notices of Allowance for two US patents, advancing its Phase 3 autism spectrum disorder program.

Amplia Therapeutics reported encouraging mature data from its ACCENT trial, initiated a Phase 2b pancreatic cancer study, launched an ovarian cancer trial, and refreshed its board leadership while maintaining a solid cash balance of A$24 million.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.

Starpharma launches a fully underwritten $32 million entitlement offer to fund the Phase 1 trial of its DEP® HER2-Lutetium radiopharmaceutical and accelerate its targeted oncology asset development.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Island Pharmaceuticals has secured a critical collaboration with Texas Biomedical Research Institute to advance dose optimisation for its antiviral Galidesivir, targeting Marburg Virus Disease under the FDA Animal Rule. This second phase complements ongoing USAMRIID efforts and aims to de-risk pivotal study design with data from 32 non-human primates.

Racura Oncology has secured Bellberry HREC approval for its HARNESS-1 lung cancer trial, enabling expansion to additional Australian sites including Chris O’Brien Lifehouse and Austin Health, setting the stage for accelerated patient enrolment.

Island Pharmaceuticals has expanded its partnership with USAMRIID to conduct a pivotal Galidesivir dose optimisation study against Marburg virus, targeting topline results in the second half of 2026.

Entropy Neurodynamics has successfully dosed all six participants in the first cohort of its Phase 2 trial for TRP-8803, an intravenous psilocin therapy targeting Binge Eating Disorder. The study demonstrated controlled psychedelic responses, setting the stage for a Data and Safety Monitoring Board review and topline results expected in July 2026.