C Ray Therapeutics Highlights FDA-Listed Cu-64 DMF and Radiopharmaceutical Platform

According to a recent LinkedIn post from C Ray Therapeutics, the company’s Type II Drug Master File for Copper-64 (Cu-64) has been listed as active by the U.S. FDA under DMF No. 43568 and is available for reference in IND and NDA submissions globally. The post highlights Cu-64’s ~12.7-hour half-life, which is described as enabling centralized production, up to 48-hour shelf life, and more flexible clinical scheduling for PET diagnostics.

The post cites clinical data suggesting that a Cu-64 SAR-bisPSMA agent in prostate cancer showed higher lesion detection versus Ga-68 PSMA-11, implying potential for improved diagnostic performance. For investors, if such performance advantages are validated more broadly, Cu-64–based diagnostics could gain share within the radiopharmaceutical imaging market.

Operationally, the company’s LinkedIn post points to a proprietary Ni-64 in-house recycling process with up to a 90% recovery rate, supporting multi-batch production and potentially lowering raw material costs. The post also notes current batch capacity above 2 Ci (after EOB) and integrated radiolabeling, formulation, fill-finish, and cold-chain distribution capabilities, which together suggest a CRDMO-style platform.

According to the post, the active DMF is positioned as a tool to reduce CMC burden and de-risk regulatory pathways for partners developing Cu-64-based diagnostics at both IND and NDA stages. This could support revenue growth via supply and manufacturing partnerships if Cu-64 demand scales in theranostics and nuclear medicine.

The company also notes planned presence at upcoming ANZSNM and SNMMI 2026 conferences, indicating active business development efforts in key nuclear medicine forums. For investors, increased visibility and partnering activity around Cu-64 infrastructure may enhance C Ray Therapeutics’ competitive position as a specialized radiopharmaceutical manufacturing and supply partner.