Theragenics and Clarity Pharmaceuticals Partner to Enable Scalable Copper-64 Supply for Next-Generation Diagnostics

Theragenics is proud to announce the signing of a Manufacturing Supply Agreement with Clarity Pharmaceuticals (ASX: CU6) for the large-scale production of copper-64, supporting Clarity’s anticipated commercial launch of 64Cu-SAR-bisPSMA, subject to regulatory approval.

This partnership brings together Clarity’s innovative clinical pipeline with Theragenics’ established manufacturing scale and expertise. Production will be supported by Theragenics’ 134,000 square foot facility near Atlanta, Georgia—home to a fleet of 14 cyclotrons and strategically located within a major U.S. logistics hub. With the ability to produce approximately 100 Ci (3.7 TBq) of copper-64 per cyclotron per day—equivalent to up to 2,000 patient doses daily—Theragenics is uniquely positioned to deliver the consistent, high-volume supply required for commercial success.

Clarity recognised Theragenics as a key partner in its supply strategy, citing the company’s “decades of experience in the commercial production of radiometals for medical purposes” and “valuable insight into the prostate cancer field.” The agreement strengthens Clarity’s manufacturing network, designed to ensure “secure, reliable and abundant supply” as it advances toward commercialisation.

Theragenics also highlighted Clarity’s strong clinical momentum and differentiated platform, noting its advanced-stage development programs, Fast Track Designations from the U.S. FDA, and the growing body of clinical evidence supporting 64Cu-SAR-bisPSMA.

Clarity commented on the collaboration: “We look forward to working with Theragenics as we prepare to take the next steps in our development.”

This agreement marks a significant step in Theragenics’ continued expansion into large-scale isotope manufacturing and reinforces its role as a trusted partner in enabling next-generation radiopharmaceutical solutions—advancing access to innovative diagnostics for patients worldwide.