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…
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…
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…
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…
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…
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…
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…
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…
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…
Sydney, Australia 19 October 2021 C-BOBCAT breast cancer trial of Clarity’s SAR-Bombesin product closes for recruitment. The diagnostic program with 64Cu SAR-Bombesin generated evidence of the utility and potential superiority in some patient subgroups compared to conventional imaging (e.g. 99mTc bone scan, 18F FDG). The high uptake and strong product retention visualised by PET imaging…