Latest Pharmacokinetics News

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.

Chimeric Therapeutics reports encouraging Phase 1/2 data for its CHM CDH17 CAR-T therapy in advanced gastrointestinal cancers, with 82% of evaluable patients achieving stable disease and durable responses lasting over a year.

Patrys has appointed CMAX and Alithia Life Sciences to lead its Phase 1A clinical trial operations for RLS-2202, advancing its injectable quetiapine program toward first-in-human testing in Q3 2026, pending ethics approval.

Island Pharmaceuticals has appointed Mark Herzog as Senior Global Health Security Advisor and secured roles in key Medical Countermeasures Coalition groups, boosting its US biodefence engagement ahead of pivotal Galidesivir Animal Rule studies.

Amplia Therapeutics has launched a Phase 2b trial testing a new daily dosing regimen of narmafotinib combined with chemotherapy in advanced pancreatic cancer, aiming to accelerate progress towards a pivotal Phase 3 study.

Neurizon Therapeutics has gained ethics approval to start a Phase 1 trial of its NUZ-001 oral liquid formulation, aiming to ease treatment for ALS patients with swallowing difficulties.

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Racura Oncology reported robust progress in Q3 FY2026, including launching a key lung cancer trial and unveiling a novel blood test for cardioprotection, supported by a solid $19.38 million cash position.