Clarity expands US copper-64 supply network ahead of potential commercial launch

About Clarity Pharmaceuticals Limited

Clarity Pharmaceuticals Limited (ASX: CU6) is a clinical-stage radiopharmaceutical company focused on the treatment of serious diseases. The company is developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers.

Theragenics agreement expands manufacturing capacity

Clarity Pharmaceuticals has entered a large-scale Manufacturing Supply Agreement with Theragenics for copper-64 production in the United States. The agreement relates to Theragenics’ 134,000 square foot production facility near Atlanta, Georgia, a major US transport hub, and is aimed at supporting centralised, large-scale copper-64 manufacturing ahead of the anticipated commercial launch of 64Cu-SAR-bisPSMA. Clarity said this launch remains contingent on successful completion of its Phase III registrational trials, AMPLIFY and CLARIFY, and subsequent approval of a New Drug Application by the US Food and Drug Administration.

Large-scale production profile supports future demand

Theragenics brings 40 years of routine radiometal production experience and significant expertise in producing medical radioisotopes. The facility operates a sizeable fleet of high-current cyclotrons, and Clarity said Theragenics has capacity to produce around 100Ci, or 3.7 TBq, of copper-64 per day on a single cyclotron. According to the company, that equates to around 2,000 patient doses per day on each cyclotron at 200 MBq per dose with a 48-hour shelf life, highlighting the scale of supply that could be available if commercial demand emerges.

Broader US supply network strengthens commercial readiness

Clarity said the Theragenics agreement further enhances its broad network of high-volume copper-64 manufacturers in distinct US geographies. The new arrangement adds to existing supply agreements with SpectronRx and Nusano, and the company said the combined network is designed to support commercial-scale demand across multiple large oncology indications. Management described the strategy as building a secure, seamless and abundant supply base for this diagnostic isotope as Clarity moves closer to potential commercialisation.

Copper-64 offers logistical and operational advantages

A central feature of Clarity’s supply strategy is the longer half-life of copper-64. The company said copper-64 has a 12.7-hour half-life, compared with less than two hours for the radionuclides currently used in PSMA PET imaging, including gallium-68 and fluorine-18. Clarity stated that this translates into a shelf life of up to 48 hours for 64Cu-SAR-bisPSMA, allowing greater flexibility for supply and scheduling of patients while supporting a multi-tiered service model of large, local, centralised manufacturing with broad geographic distribution.

Management highlights momentum in development program

Theragenics Chief Executive Officer Mark Pugh said the company viewed Clarity as well positioned given its two diagnostic Phase III trials nearing completion, three Fast Track Designations from the US FDA and the data generated to date. Clarity Executive Chairperson Dr Alan Taylor said the company was closer than ever to commercialisation of 64Cu-SAR-bisPSMA, pointing to recently released data from the head-to-head Co-PSMA investigator-initiated trial and the achievement of Clarity’s target number of participants in the Phase III AMPLIFY trial.

Commercial planning continues, subject to approval

Clarity said building out a secure, reliable and abundant supply and manufacturing strategy is now becoming increasingly important as it prepares for a potential commercial launch and accelerated market expansion, subject to FDA approval. The Manufacturing Supply Agreement became effective on 25 March 2026, with cancellation and extension provisions aligned with industry standard rates. The company also noted that 64Cu-SAR-bisPSMA is an unregistered product whose safety and efficacy have not been assessed by authorities including the FDA and the Therapeutic Goods Administration, and there is no guarantee the product will become commercially available.

Outlook

Looking ahead, Clarity appears focused on converting clinical and regulatory progress into commercial readiness. The Theragenics agreement strengthens the company’s US manufacturing footprint and complements its existing copper-64 supply arrangements, positioning it to support larger-scale distribution if 64Cu-SAR-bisPSMA secures approval. While the product remains unregistered and subject to successful Phase III trial outcomes and FDA review, Clarity’s expanding supply network, longer-lived isotope platform and ongoing trial momentum suggest the company is laying the groundwork for a broader commercial rollout in the US market.