-- Clarity Pharmaceuticals (ASX:CU6) signed a commercial manufacturing agreement for its Cu-64 SAR-bisPSMA next-generation diagnostic imaging agent with Nucleus Radiopharma, according to a Tuesday filing with the Australian bourse.
The agreement includes manufacturing at Nucleus Radiopharma's facility in Rochester, Minnesota, which has a production capacity of around 50,000 patient doses per year, as well as future production at a Spring House, Pennsylvania, facility planned to open in 2028 with a capacity of up to 600,000 doses per year.
The two facilities will service key commercial markets, with distribution to all 50 US states and some international locations including Europe, per the filing.
Clarity Pharmaceuticals plans to commercially launch the new diagnostic imaging agent after completing phase 3 registrational trials and obtaining new drug application approval from the US Food and Drug Administration.