Category Archives: Press Releases

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…

Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Phase III trial in patients with recurrence of prostate cancer

Sydney, Australia 14 October 2024 Highlights United States Food and Drug Administration (U.S. FDA) provided positive feedback on a pivotal Phase III trial for 64Cu-SAR-bisPSMA diagnostic in prostate cancer patients with biochemical recurrence (BCR), AMPLIFY. The positive results of the completed COBRA and PROPELLER trials, including the significantly higher uptake and retention in lesions compared…

Clarity promotes Michelle Parker to CEO

Sydney, Australia 14 October 2024 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the 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 the appointment of Ms Michelle Parker as Chief Executive Officer (CEO), effective from 11 October 2024. Dr…

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

Sydney, Australia 8 October 2024 Highlights Clarity has entered into a 64Cu-SAR-bisPSMA Clinical Manufacturing Agreement for its Phase III clinical trials with SpectronRx. This Clinical Manufacturing Agreement builds on the earlier Master Service Agreement and associated Supply Agreement for the copper-64 (Cu-64 or 64Cu) isotope with SpectronRx, effective as of 30 May 2024. SpectronRx will…

Clarity’s COBRA study selected as a Top-Rated Oral Presentation at prestigious industry Annual Meeting

Sydney, Australia 1 October 2024 Highlights Two abstracts outlining Clarity’s latest SAR-bisPSMA data have been accepted to be presented at the upcoming European Association of Nuclear Medicine (EANM) 2024 Congress on the 19-23 October. Abstracts on the diagnostic clinical trial, COBRA, and a theranostic case report (complete response in a patient with metastatic castrate-resistant prostate…

SECuRE trial advances: No dose limiting toxicities and strong preliminary efficacy data in first multi-dose cohort

Sydney, Australia 12 September 2024 Highlights Cohort 4 of the SECuRE trial is the first to assess multiple cycles of 67Cu-SAR-bisPSMA at the highest dose of 12GBq. The Safety Review Committee (SRC) assessed early data from the first 3 participants in cohort 4 who received 2 doses of 67Cu-SAR-bisPSMA. Two of these participants had completed…

Changes to Clarity’s Board of Directors & Management Team

Sydney, Australia 26 August 2024 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the 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 Board and senior team changes as Clarity progresses its multiple clinical and pre-clinical programs and navigates through…

Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA

Sydney, Australia 22 August 2024 Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the 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 for 64Cu-SAR-bisPSMA for positron…