Sydney, Australia 26 September 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, confirms that Clarity’s Targeted Copper Theranostic (TCT) products and clinical development programs will remain unaffected by the United States’ (US) imposed 100% tariff on imports of branded pharmaceutical products that will take effect from October 1.
Clarity also confirms that all of its isotope and drug product manufacturers for its US clinical trial sites are located in the US. Clarity’s strategy is to target the US market for first approvals of its products with five open Investigational New Drug (IND) applications from the US Food and Drug Administration (FDA). The Company’s registrational Phase III diagnostic trials and Phase I/IIa theranostic trial are located in the US with all products for these US-based trials manufactured and shipped from within the US. By building a supply chain that is fully integrated, from high-volume isotope production, to centralised product manufacture, to delivering these ready-to-use diagnostics to imaging sites in every state of the US on time and on demand, Clarity is aiming to build a model that is impervious to current political dynamics.
Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: “Clarity’s products, from isotope manufacture to finished product, are made in America for Americans. Copper-64 and copper-67 are made on cyclotrons and electron accelerators, respectively, which are located in the US. Our finished products are made at sites in the US for the US market. Large-volume, centralised manufacture of diagnostic and therapeutic products is enabled by the perfect pairing of copper isotopes and our proprietary SAR chelator technology. We do not rely on the generators which are required for the manufacturing of short half-life isotopes, nor do we rely on the research reactors needed for lutetium-177 production, the majority of which are based outside the US. We look forward to continuing our US-focused commercialisation strategy, working with our key US partners and clinical sites as we quickly progress our products to market in pursuit of our ultimate goal of better treating people with cancer.”
About Clarity Pharmaceuticals
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers.
Media Contacts
Clarity Pharmaceuticals
Dr Alan Taylor
Executive Chairperson
ataylor@claritypharm.com
Lisa Sadetskaya
Director, Corporate Communications
lisa@claritypharm.com
