Latest Biopharmaceuticals News

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.

Race Oncology has uncovered that its anticancer drug bisantrene exists as three light-sensitive isomers, with only one showing potent activity. The company has filed patents to protect this active form, potentially extending its intellectual property rights until 2045.

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.

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.

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.

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.

Clinuvel Pharmaceuticals has reported its ninth consecutive year of revenue and profit growth, driven by strong sales of SCENESSE® and strategic investment in vitiligo clinical trials. The company also declared its eighth consecutive dividend, underscoring financial resilience.

Clinuvel Pharmaceuticals reports steady financial growth with an 8% rise in revenue and 2% profit increase, while expanding its US commercial footprint and completing recruitment for a pivotal vitiligo trial.

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.

NeuroScientific Biopharmaceuticals reports encouraging early clinical results for its StemSmart™ MSC therapy in preventing and treating kidney transplant rejection and injury.