Sydney, Australia 5 March 2025 Highlights Clarity has signed a new agreement with The University of Queensland (UQ) advanced imaging at the Australian Institute for Bioengineering and Nanotechnology (AIBN) for supply of copper-64 (Cu-64 or 64Cu) isotope. The copper-64 supply will be used to expand the manufacturing capability of the diagnostic 64Cu-SAR-bisPSMA product for the…
Sydney, Australia 5 March 2025 Highlights Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study. Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC confirmed expansion at…
Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the United States (US) Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 67Cu-SAR-bisPSMA…
Sydney, Australia 11 February 2025 Highlights Clarity renews its focus on the breast cancer market, spearheaded by 64/67Cu-SAR-trastuzumab and reinforced by its SAR-Bombesin, SARTATE and SAR-bisPSMA products in this indication. It is estimated that 316,950 women will be diagnosed with invasive breast cancer in 2025 in the United States (US), with 42,170 dying from the disease1.…
Sydney, Australia 28 January 2025 Highlights Two abstracts on Clarity’s diagnostic COBRA and CLARIFY trials with 64Cu-SAR-bisPSMA have been accepted for presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025. An abstract on the COBRA study has also been selected for presentation at the American Urological Association (AUA) Annual Meeting…
Sydney, Australia 24 January 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron…
Sydney, Australia 18 December 2024 Highlights Clarity has developed a proprietary fibroblast activation protein (FAP)-targeted radiopharmaceutical product that can be used with the perfect pairing of copper isotopes for the diagnosis and treatment of cancer. The product, termed SAR-bisFAP, has shown strong tumour targeting, retention and pharmacokinetic data to date in pre-clinical models. FAP is…
Sydney, Australia 28 November 2024 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the last patient has completed their final assessment in the Phase II diagnostic 64Cu-SARTATE trial, DISCO (NCT04438304)1, for…
Sydney, Australia 26 November 2024 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that two participants have been dosed and imaged days after the commencement of the Co-PSMA Investigator-Initiated Trial (IIT). The study…
Sydney, Australia 11 November 2024 Highlights Nucleus RadioPharma will manufacture the 67Cu-SAR-bisPSMA drug product at their new state-of-the-art facility in Rochester, MN. The Master Services Agreement (MSA) and Clinical Supply Agreement with Nucleus RadioPharma complement the existing agreement with NorthStar Medical Radioisotopes, LLC (NorthStar) for 67Cu-SAR-bisPSMA production to expand drug manufacturing in anticipation of recruitment…