Category Archives: Press Releases

Clarity expands pipeline in breast cancer with Cu-64/67 SAR-trastuzumab: Pre-clinical data published and trastuzumab supply agreement in place

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.…

Clarity to present COBRA and CLARIFY abstracts at two world-leading conferences

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…

Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer

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…

Clarity expands its pipeline with a novel optimised FAP-targeted radiopharmaceutical

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…

Last patient assessment completed for diagnostic SARTATE trial in NETs

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…

First 2 participants dosed with Cu-64 SAR-bisPSMA in Co-PSMA trial

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…

St Vincent’s Hospital to conduct head-to-head trial with Clarity’s SAR-bisPSMA diagnostic product

Sydney, Australia 18 November 2024 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, a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is…

Clarity and Nucleus RadioPharma sign Master Services Agreement and Cu-67 SAR-bisPSMA Clinical Supply Agreement

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…

CMS final rule on radio-diagnostic reimbursement policy, expanding patient access to products

Sydney, Australia 5 November 2024 Highlights The U.S. Centers for Medicare and Medicaid Services (CMS) has published its final rule for CY2025, which establishes a separate payment for high value radiopharmaceutical diagnostics after the expiry of transitional pass-through status. The final ruling is a landmark victory for the radiopharmaceutical industry, promising relative price stability and…

Copper-67 SAR-bisPSMA updates

Sydney, Australia 16 October 2024 Highlights Cohort 4 – SECuRE Trial The third participant of cohort 4 (multi-dose) of the SECuRE trial1 has now completed the Dose Limiting Toxicity (DLT) period after a second dose of 12GBq of 67Cu-SAR-bisPSMA, following on from the announcement dated 12 September 20242. The patient is a 93-year-old with a…