Latest Biopharmaceutical News

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.

Zelira Therapeutics has raised nearly US$33 million from ThirdGate Capital to advance its HOPE® 1 drug targeting autism-related Phelan-McDermid Syndrome through FDA clinical trials. This funding milestone sets the stage for pivotal regulatory progress in the US.

NeuroScientific Biopharmaceuticals reports encouraging clinical responses in fistulising Crohn’s disease patients treated under Australia’s Special Access Scheme, setting the stage for pivotal Phase 2 trials later this year.

Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.

Dimerix secures FDA confirmation that proteinuria reduction is a valid primary endpoint for its Phase 3 ACTION3 trial, advancing its kidney disease drug DMX-200 closer to approval.

BioMarin Pharmaceutical’s acquisition of Amicus Therapeutics for US$4.8 billion includes Dimerix’s US licensing agreement, promising significant milestone payments and royalties. This deal strengthens Dimerix’s position as it advances its Phase 3 kidney disease therapy.

Neurotech International has locked in $4 million through a share placement to advance its promising paediatric neurological drug, NTI164. The raise, supported by both new and existing investors including company directors, aims to fund critical clinical and regulatory milestones.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Race Oncology has received a $2.8 million Australian R&D tax refund for FY2025, with further overseas R&D rebates expected, bolstering its clinical development of innovative cancer therapies.

Race Oncology Limited has secured shareholder approval for a replacement Constitution at its 2025 Annual General Meeting, updating its corporate governance framework to align with current regulatory standards.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.