Latest Pharmacokinetics News

Anatara Lifesciences delivered ambiguous mechanism of action results for its Anti-Obesity Project while reporting statistically significant weight management effects from compound AOC. The company plans a limited Phase 1 study but may delay it amid ongoing strategic discussions, with cash reserves tightening to $0.7 million.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Island Pharmaceuticals has cleared a major regulatory hurdle with the US FDA, confirming a clinical development path for its antiviral Galidesivir under the Animal Rule. Backed by a $9 million capital raise and strategic partnerships, the company is poised for potential US government procurement and biodefence market entry.

Noxopharm reports preclinical data revealing SOF-SKN’s active ingredient remains in skin tissues for about 3.5 days with minimal systemic absorption, supporting less frequent dosing and sustained activity for cutaneous lupus treatment.

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

Nexalis Therapeutics has advanced its IRX-211 program by screening the first patient in a pivotal Phase 2 trial for Breakthrough Cancer Pain, aiming to address a significant unmet need in oncology supportive care.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Nexalis Therapeutics has initiated dosing in its Phase 1 trial of IRX-616a, a novel cannabidiol inhalation treatment targeting panic disorder. The trial aims to evaluate safety and pharmacokinetics, with dose escalation decisions expected soon.

Immutep Limited has successfully completed the single ascending dose phase of its IMP761 trial, showing promising safety and immunosuppressive effects in healthy volunteers. The biotech’s novel LAG-3 agonist could reshape autoimmune disease treatment.

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.