Sydney, Australia 29 May 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 patients with cancer, is pleased to announce that it has imaged the first patient in its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in participants with biochemical recurrence…
Sydney, Australia 20 May 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 patients with cancer, is pleased to announce that it has commenced its second registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, AMPLIFY (NCT06970847)1, with the initiation…
Sydney, Australia 17 April 2025 Highlights Clarity has signed a commercial-scale agreement with Nusano, Inc. (“Nusano”) for supply of copper-64 (Cu-64 or 64Cu) isotope. The 190,000 square foot Nusano facility in West Valley City, Utah is capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity, which translates into more…
Sydney, Australia 17 April 2025 Highlights Clarity received an $11,146,204 Research and Development (R&D) Tax Incentive refund, inclusive of interest, as part of the Australian Federal Government’s R&D Tax Incentive program. The receipt of the $11.1 million will provide additional funding to further the development of Clarity’s Targeted Copper Theranostic (TCT) platform of products for…
Sydney, Australia 15 April 2025 Highlights The first of the planned 24 participants in the Cohort Expansion Phase (Phase II) of the SECuRE trial has been treated with their first dose of 8 GBq of 67Cu-SAR-bisPSMA.This follows the recent recommendation by the Safety Review Committee (SRC) after the successful completion of the Dose Escalation Phase…
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…