Latest Biopharmaceuticals News

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.

Telix Pharmaceuticals reports positive Phase 3 results for its prostate cancer imaging agent Illuccix in China, paving the way for a near-term regulatory submission. Meanwhile, the company advances FDA resubmissions for its glioma and kidney cancer imaging candidates.

Telix Pharmaceuticals confirms completion of Part 1 enrolment in its ProstACT Phase 3 trial for prostate cancer, with safety data supporting progression to Part 2 and regulatory approvals secured across multiple countries.

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.

Radiopharm Theranostics reports promising interim Phase 2b results for RAD 101, achieving 92% concordance with MRI in detecting brain metastases, paving the way for a pivotal study in 2026.

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 raised $3.22 million through a private placement to fund its HARNESS-1 Phase 1a/b trial targeting non-small cell lung cancer, with patient enrolment expected early next year.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.

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 has received ethics approval to launch its HARNESS-1 Phase 1a/b trial testing RC220 combined with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward addressing resistance to current therapies.

Zelira Therapeutics has received a $1.07 million cash refund under Australia’s R&D Tax Incentive Scheme, reinforcing its funding for ongoing clinical trials and product development. The company has also repaid a prior loan advanced against this claim, positioning it for continued growth in cannabinoid-based medicines.

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.