Latest Biopharmaceuticals News

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Opthea Limited has received a substantial A$10.8 million R&D tax incentive from the Australian government, reinforcing its commitment to advancing its novel drug candidate sozinibercept. This funding milestone underscores the company’s strategic focus on innovation and fiscal discipline.

Invex Therapeutics has ended negotiations on two neurological asset acquisitions following due diligence setbacks and shareholder disputes, while advancing R&D collaborations and managing financial stability.

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.

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.