Latest Biopharmaceuticals News

Paradigm Biopharmaceuticals has achieved 50% patient enrolment in its pivotal Phase 3 trial for injectable pentosan polysulfate sodium, advancing steadily towards an interim analysis expected in August 2026.

Radiopharm Theranostics has initiated dosing in its Phase 1 clinical trial of RAD 402, a novel radiolabelled antibody targeting KLK3 in advanced prostate cancer. Early data from the trial’s initial dose levels are expected in the second half of 2026.

Radiopharm Theranostics reports promising second interim Phase 2b results for RAD 101, showing 90% concordance with MRI in detecting brain metastases and encouraging sensitivity and specificity trends.

Recce Pharmaceuticals is progressing its Phase 3 clinical trial of RECCE 327, a novel synthetic antibiotic targeting multidrug-resistant infections, with interim data from Indonesia supporting registration plans across ASEAN by 2026.

Neurotech International has opened the first clinical site for its pivotal Phase 3 trial of NTI164, targeting core symptoms of Autism Spectrum Disorder in children. This milestone marks a key step toward potential regulatory approval and commercialisation.

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.

Dimerix Limited is set to conduct a blinded statistical review of its pivotal Phase 3 ACTION3 study in March 2026, aiming to confirm the trial remains powered to demonstrate the primary endpoint of proteinuria reduction in FSGS patients.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.

Dimerix Limited has completed dosing of the last adult patient in its ACTION3 Phase 3 trial for DMX-200, exceeding its recruitment target and setting the stage for key regulatory milestones.

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.

Paradigm Biopharmaceuticals reports a sharp rise in half-year losses as it intensifies investment in its pivotal Phase 3 trial for knee osteoarthritis, setting sights on a critical interim analysis in mid-2026. The company also expands its osteoarthritis pipeline and maintains strong funding amid a strengthening biotech sector.

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.