Latest Pharmacokinetics News

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

Patrys has cleared a key regulatory hurdle with Human Research Ethics Committee approval for its Phase 1A clinical trial of RLS-2202, aiming to start dosing healthy volunteers this quarter.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.

Neurizon Therapeutics has completed enrolment in its pivotal HEALEY ALS Platform Trial ahead of schedule, secured critical manufacturing and funding agreements, and reduced its net loss for FY2026 while preparing for topline results in late Q2 2027.

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.