Category Archives: News

Clarity enters a Commercial Manufacturing Agreement for Cu-64 SAR-bisPSMA with SpectronRx

Sydney, Australia 17 June 2025 Highlights Clarity has entered into a Commercial Manufacturing Agreement with SpectronRx for 64Cu-SAR-bisPSMA. SpectronRx’s facility in Indiana will provide on-demand commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA under one roof and enables distribution to all 50 states. SpectronRx will expand current production to up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA…

SABRE topline results: Cu-64 SAR-Bombesin is effective in detecting prostate cancer recurrence in patients with negative SOC imaging

Sydney, Australia 13 June 2025 Highlights Topline data from Clarity’s diagnostic Phase II trial, SABRE, showed that 64Cu-SAR-Bombesin was safe, well tolerated and effective at detecting prostate cancer in patients with biochemical recurrence (BCR) who are negative or equivocal on standard-of-care (SOC) scans, including prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET). SAR-Bombesin targets the gastrin-releasing…

DISCO topline results: Cu-64 SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.

Sydney, Australia 5 June 2025 Highlights Topline data from Clarity’s diagnostic Phase II trial, DISCO, confirms that 64Cu-SARTATE is safe and highly effective compared to standard-of-care (SOC) imaging at detecting lesions in patients with neuroendocrine tumours (NETs). DISCO compared the diagnostic performance of 64Cu-SARTATE at an average of 4 hours (between 3 to 5 hours) and 20…

First patient imaged in Phase III AMPLIFY trial with Cu-64 SAR-bisPSMA PET/CT

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…

Registrational Phase III AMPLIFY trial in biochemical recurrence of prostate cancer commences

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…

Clarity signs high-volume commercial-scale copper-64 Supply Agreement with Nusano

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…

Clarity receives $11.1 million R&D Tax Incentive refund. Over $100 million in funding and refocus on high-priority programs.

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…

SECuRE trial update: First patient treated in the Phase II Cohort Expansion

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…

Clarity signs Cu-64 Supply Agreement with The University of Queensland

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…

SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.

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…