Clarity Pharmaceuticals (ASX:CU6) has announced a landmark commercial manufacturing agreement with Nucleus RadioPharma.
The partnership focuses on the large-scale production of 64Cu-SAR-bisPSMA, a next-generation diagnostic imaging agent designed to detect prostate cancer lesions that often remain invisible under current standards of care.
The agreement leverages Nucleus RadioPharma's state-of-the-art facilities to ensure a robust supply chain ahead of the product’s anticipated commercial launch.
Manufacturing will initially take place at the Rochester, Minnesota, site—capable of producing approximately 50,000 patient doses annually—before expanding to a 47,000-square-foot facility in Spring House, Pennsylvania, by 2028.
The expansion is projected to increase capacity to 600,000 doses per year, providing comprehensive coverage across all 50 US states and select international markets, including Europe.
Executive leadership from both firms emphasised the clinical impact of this collaboration.
Dr Alan Taylor, Executive Chairperson of Clarity, noted that the long half-life of copper-64 provides the logistical freedom required to meet global demand through centralised manufacturing.
Meanwhile, Nucleus RadioPharma's leadership highlighted that earlier detection through this technology directly improves patient management and outcomes.
At the time of reporting, Clarity Pharmaceuticals' share price was $2.95.