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Gus Iversen, Editor in Chief | April 17, 2026
Clarity Pharmaceuticals has entered a commercial manufacturing agreement with Nucleus RadioPharma to support production of its investigational prostate cancer imaging agent, Cu-64 SAR-bisPSMA, as the company prepares for a potential market launch.
The Sydney-based radiopharmaceutical developer said the deal covers manufacturing at Nucleus facilities in Rochester, Minnesota, and a planned site in Spring House, Pennsylvania. The Rochester facility is designed to produce about 50,000 patient doses annually, while the Pennsylvania site, expected to open in 2028, could add capacity of up to 600,000 doses per year.
Together, the sites are intended to support distribution across the U.S. and selected international markets, including Europe. The agreement builds on an existing partnership between the two companies that includes a master services agreement and a clinical supply arrangement for a related isotope, Cu-67 SAR-bisPSMA.
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Clarity is advancing Cu-64 SAR-bisPSMA through Phase III trials, including the AMPLIFY and CLARIFY studies, and plans to seek U.S. Food and Drug Administration approval following completion of those trials. The compound is designed for positron emission tomography imaging targeting prostate-specific membrane antigen.
Geoffrey Johnson, chief scientific officer at the Rochester, Minnesota-based Nucleus RadioPharma, said the agent has shown the ability to detect smaller lesions compared with current PSMA PET imaging in clinical data. “Earlier cancer detection and better cancer staging directly affects patient management and treatment outcomes and I firmly believe that seeing is saving,” he said.
Clarity said the agreement is part of a broader manufacturing strategy that includes supply arrangements with SpectronRx, Nusano and Theragenics, as well as a separate commercial manufacturing agreement with SpectronRx. The company is building a distributed production network intended to support regional supply and scale.
The agreement took effect April 14, 2026. Cu-64 SAR-bisPSMA and related compounds remain investigational and have not been approved by regulators.
