Latest Biopharmaceuticals News

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.

Entropy Neurodynamics reports a 14.8% reduction in half-year losses while progressing a pioneering clinical trial for Binge Eating Disorder using its proprietary psychedelic drug TRP-8803. The company also secured $6.1 million in new funding and strategic collaborations to enhance its neuropsychiatry platform.

Neurotech International reports a dramatic reduction in half-year losses alongside significant clinical and regulatory progress for its lead cannabinoid therapy NTI164. The company also strengthens its cash position through a $4 million placement and a $4.7 million R&D tax refund.

Immuron Limited reported a narrower half-year loss alongside record sales growth and FDA approval for its IMM-529 drug candidate, signalling promising clinical and commercial momentum.

Radiopharm Theranostics has initiated dosing in its Phase 1/2a clinical trial of BetaBart, a novel radiotherapeutic developed with MD Anderson Cancer Center, targeting aggressive solid tumors.

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Argent BioPharma has completed its largest commercial shipment of CannEpil® to Ireland, marking a key milestone in its European expansion with a delivery valued at approximately AUD 783,000. The product is fully reimbursed under Ireland’s National Health Insurance scheme, enhancing patient access for refractory epilepsy treatment.

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

Paradigm Biopharmaceuticals has published a pivotal study in PLOS ONE showing sustained pain relief and joint repair in dogs treated with pentosan polysulfate sodium, reinforcing its potential for human osteoarthritis therapy.

Racura Oncology has developed a pioneering blood test that promises to fast-track key data on its cardioprotective drug RC220, potentially shaving two years off the clinical trial timeline. This innovation also enhances patient safety and recruitment prospects in the ongoing RAC-010 CPACS trial.

Island Pharmaceuticals has raised $9 million to advance its antiviral drug Galidesivir through the FDA’s Animal Rule pathway, targeting inclusion in the US Strategic National Stockpile for biodefense viruses.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.