Latest Biopharmaceuticals News

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Race Oncology has activated its first clinical trial site in Hong Kong for the Phase 1 study of RC220 combined with doxorubicin in advanced solid tumours, marking a significant step in accelerating patient enrolment and broadening clinical data.

ASF Group Limited reports a dramatic turnaround to a $25.8 million profit for FY2025, driven by a one-off $32.7 million gain from subsidiary disposals amid a 70% revenue drop.

Zelira Therapeutics reported a significantly reduced loss of AUD 3.85 million for FY25, driven by clinical progress and strategic funding for its HOPE® cannabinoid medicines. The company also expanded its patent portfolio and commercial footprint across key markets.

Paradigm Biopharmaceuticals marked FY25 with the launch of its global Phase 3 trial for its osteoarthritis drug iPPS, backed by strong FDA protocol approval and a $41 million funding facility. The company also broadened its pipeline with the acquisition of Pentacoxib™, targeting early-stage OA.

Immuron Ltd reported a robust 49% increase in FY25 global sales, driven by strong Travelan® growth, while gearing up for a ProIBS launch and pivotal FDA meetings in 2025-26.

NeuroScientific Biopharmaceuticals reported a $1.85 million loss for FY25, driven by reduced R&D incentives and increased development costs following its acquisition of StemSmart™ technology. The company is advancing clinical programs, including a Special Access Scheme for Crohn’s disease.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.