- Clarity Pharmaceuticals has signed a Commercial Manufacturing Agreement with Nucleus Radiopharma to produce 64Cu-SAR-bisPSMA for prostate cancer diagnostics.
- The agreement supports manufacturing capacity across U.S. facilities, including up to 600,000 doses annually from a planned Pennsylvania site.
Clarity Pharmaceuticals has entered into a Commercial Manufacturing Agreement with Nucleus Radiopharma to support the production of its diagnostic imaging agent, 64Cu-SAR-bisPSMA, for prostate cancer. The agreement strengthens the company’s contract manufacturing network as it prepares for potential commercial launch following Phase III trials and regulatory review.
The agreement covers Nucleus Radiopharma’s facility in Rochester, Minnesota, which has the capacity to manufacture approximately 50,000 patient doses per year. It also includes future production at a 47,000-square-foot facility in Spring House, Pennsylvania, expected to open in 2028 with capacity of up to 600,000 doses annually. These sites are intended to support distribution across the United States and selected international markets, including Europe.
The partnership builds on an existing relationship between the two companies, which includes a Master Services Agreement and a clinical supply agreement for 67Cu-SAR-bisPSMA established in November 2024. The new agreement expands manufacturing capabilities for commercial-scale supply as Clarity advances its lead program.
64Cu-SAR-bisPSMA is being developed as a diagnostic imaging agent designed to detect prostate cancer lesions. The company is currently conducting Phase III registrational trials, AMPLIFY and CLARIFY, with plans to pursue U.S. Food and Drug Administration approval following their completion.
“We are pleased to continue growing our partnership with Clarity through this new Commercial Manufacturing Agreement. At Nucleus RadioPharma, we share Clarity’s goal of improving treatment outcomes for patients with cancer and look forward to delivering novel products to people in need of better diagnostic and therapeutic options.”
Stephen Hahn, Chief Executive Officer of Nucleus Radiopharma
