Latest Biopharmaceuticals News

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.

Paradigm Biopharmaceuticals reports solid progress in its Phase 3 knee osteoarthritis trial, expanding internationally and publishing key Phase 2 biomarker data. The company maintains a robust cash position to support ongoing clinical milestones.

Neurotech International has secured a Rare Pediatric Disease Designation from the FDA for its lead drug NTI164 targeting Rett syndrome, alongside publishing promising clinical data and raising $8.7 million to fuel further development.

NeuroScientific Biopharmaceuticals has reported promising initial clinical responses from its StemSmart™ Special Access Program treating Fistulising Crohn’s Disease, while preparing for a pivotal Phase 2 trial in 2026.

Argent BioPharma has restructured its acquisition of AusCann assets to sharpen its clinical focus and secured a substantial A$11 million financing facility, positioning itself for growth in 2026.

Dimerix Limited has completed recruitment for its pivotal ACTION3 Phase 3 trial targeting a rare kidney disease, secured positive FDA feedback on trial endpoints, and reported a solid cash position of AU$38.5 million at the end of 2025.

Paradigm Biopharmaceuticals has secured independent validation of its Phase 2 iPPS biomarker study, published in a leading rheumatology journal, reinforcing the scientific basis for its Phase 3 osteoarthritis trial.

Patrys Limited has acquired Reliis, gaining a promising injectable formulation of quetiapine aimed at treating delirium with a rapid FDA approval pathway. This move positions Patrys at the forefront of addressing a significant unmet medical need in critical care.

Radiopharm Theranostics has reported promising interim results from its Phase 2b trial of RAD 101, showing high concordance with MRI in brain metastases patients, while progressing multiple other clinical programs and securing a strong cash position to fund operations into 2027.

Invex Therapeutics reports promising new data from its collaboration with Tessara Therapeutics on Exenatide’s potential in Alzheimer’s disease, alongside significant board changes and a solid cash position at quarter’s end.

Telix Pharmaceuticals has met its upgraded FY 2025 revenue guidance with US$804 million, driven by strong growth in its Precision Medicine segment and the successful US launch of Gozellix. The company also advanced multiple clinical trials and announced a strategic collaboration with Varian to combine radiopharmaceuticals with radiation therapy.

Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.