Clarity Pharmaceuticals (ASX:CU6) has announced a large-scale manufacturing supply agreement for copper-64 with US-based Theragenics.
The company said the deal signals a clear move from late-stage clinical development toward building the infrastructure required for a potential commercial launch of its lead diagnostic candidate, 64Cu SAR bisPSMA.
At the centre of the agreement is Theragenics’ expansive production facility near Atlanta, Georgia, a strategically located transport hub equipped with 14 cyclotrons.
The site is designed to enable centralised, high-volume production of copper-64, a radioisotope that plays a critical role in next-generation cancer imaging. This capacity is expected to support Clarity’s anticipated commercial rollout, contingent on the successful completion of its Phase 3 trials and regulatory approval in the United States.
Theragenics brings decades of radiometal production expertise to the partnership, alongside the ability to generate substantial daily output. A single cyclotron at the facility can produce enough copper-64 to support approximately 2,000 patient doses per day, highlighting the scalability of the arrangement. Clarity said this agreement complements existing supply deals and strengthens a geographically diverse manufacturing network designed to ensure reliability and redundancy across the US market.
Clarity said the agreement represents a shift toward a more scalable, economically efficient model for radiodiagnostics, one that could expand patient access while improving operational viability for providers.