Latest Biopharmaceuticals News

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.

An independent in vivo study from the University of South Florida reveals ArtemiC™ significantly boosts survival and reduces inflammation in a severe viral model, reinforcing its promise as a novel immunomodulatory therapy.

CLINUVEL Pharmaceuticals is preparing to elevate its American Depository Receipt program to a Nasdaq Level II listing by the end of 2025, aiming to enhance visibility and trading access in the U.S. without altering its primary ASX listing.

Telix Pharmaceuticals reported a robust 63% revenue increase in H1 2025, driven by commercial growth and strategic investments, while advancing key clinical trials and maintaining full-year guidance.