Latest Biopharmaceutical News

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.

Radiopharm Theranostics has secured ethics approval to begin a Phase 1 clinical trial of RAD 402, a pioneering radiotherapeutic targeting advanced prostate cancer using terbium-161. This marks a significant step in developing a potentially safer, more effective treatment option.

Paradigm Biopharmaceuticals has drawn down US$5 million under its convertible note facility to fund the accelerated expansion of its global Phase 3 trial for knee osteoarthritis treatment.

Argent BioPharma has locked in an A$11 million convertible financing facility to finalize its strategic acquisition of AusCann assets and accelerate its growth plans, including a potential US stock exchange listing.

Radiopharm Theranostics has reached the halfway mark in enrolling patients for its Phase 2b trial of RAD101, a novel imaging agent targeting brain metastases. Early data suggest RAD101 may outperform MRI in distinguishing tumor recurrence from radiation damage.