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…

Clarity signs supply agreement for Ac-225 with TerraPower Isotopes and launches Ac-225 bisPSMA program

Sydney, Australia 16 July 2024 Highlights Agreement signed with TerraPower Isotopes (TerraPower) for the supply of the therapeutic alpha-emitting isotope, actinium-225 (Ac-225 or 225Ac), for Clarity’s first Targeted Alpha-particle Therapy (TAT) program with bisPSMA. Clarity is now well positioned to develop a best-in-class TAT 225Ac-bisPSMA product with secure supply combined with the increased uptake and…

Clarity confirms no supply disruptions for its ongoing clinical trial programs

Sydney, Australia 7 June 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, confirms Clarity’s Targeted Copper Theranostic (TCT) products and clinical development programs using copper-67 (Cu-67 or 67Cu) are unaffected by a recent…

Clarity strengthens Cu-64 network with new supply agreement with SpectronRx

Sydney, Australia 30 May 2024 Highlights Agreement with SpectronRx ensures seamless supply of the diagnostic copper-64 (Cu-64 or 64Cu) isotope for Clarity’s products which continue to progress through clinical trials, including a pivotal Phase III clinical trial. Cu-64 has an ideal 12.7-hour half-life that helps to overcome the overwhelming supply restraints of current-generation radiodiagnostics based…