Latest Pharmacokinetics News

Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.

Telix Pharmaceuticals has announced that Part 1 of its ProstACT Phase 3 trial for TLX591-Tx met its primary safety and dosimetry objectives, with no new safety concerns. The study’s success supports ongoing global enrolment in Part 2 and regulatory engagement in the US.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.

Bio-Gene Technology Limited reports strong progress in toxicology studies for Flavocide, targeting its first regulatory submission in Australia by March 2027. This milestone sets the stage for global registrations of the novel insecticide with a new mode of action.

Nyrada Inc. reported a $3.19 million loss for the half-year ending December 2025, while advancing its lead drug candidate Xolatryp® into Phase IIa clinical trials targeting heart attack treatment.

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

InhaleRx Limited has progressed its clinical trials for three drug candidates targeting cancer pain, panic disorder, and treatment-resistant depression, while securing additional funding and preparing for a company rebrand.

Arovella Therapeutics has secured a crucial regulatory nod from the U.S. FDA, allowing its lead CAR-iNKT cell therapy, ALA-101, to enter first-in-human clinical trials targeting blood cancers.

LTR Pharma has marked a key milestone with over 1,000 SPONTAN prescriptions under Australia’s Special Access Scheme and is advancing clinical trials and US market preparations for its erectile dysfunction treatments.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.