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…

Clarity to present at three world leading conferences

Sydney, Australia 3 May 2024 Highlights Eight abstracts have been accepted by the American Urological Association (AUA), American Society of Clinical Oncology (ASCO) and Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meetings, showcasing the latest data from Clarity’s oncology portfolio. Abstracts of Clarity’s diagnostic clinical trials COBRA and CLARIFY were accepted for…

Clarity Update: Complete response in first patient ever treated with 2 doses of Cu-67 SAR-bisPSMA at 8GBq

Sydney, Australia 30 April 2024 Highlights A complete response, based on Response Evaluation Criteria In Solid Tumours (RECIST v1.1) assessment, has been reported from the first patient with metastatic castrate-resistant prostate cancer (mCRPC) to ever receive two cycles of Clarity’s 67Cu-SAR-bisPSMA at the 8GBq dose level. The patient remains with undetectable levels of Prostate Specific…

Clarity successfully completes fully underwritten Retail Entitlement Offer

Sydney, Australia 24 April 2024 Highlights Clarity has successfully completed the fully underwritten Retail Entitlement Offer component of its capital raising, raising approximately $10.8 million (before costs) Completion of the Retail Entitlement Offer represents the final stage of the fully underwritten Placement and Entitlement Offer announced by Clarity on 26 March 2024 which has raised…