C Ray Therapeutics Highlights FDA-Active Cu-64 DMF and Manufacturing Capabilities

According to a recent LinkedIn post from C Ray Therapeutics, the company’s Type II Drug Master File (DMF) for Copper-64 (Cu-64) has been listed as active by the U.S. FDA under DMF No. 43568 and is now available for reference in IND and NDA submissions globally. The post emphasizes that Cu-64’s ~12.7-hour half-life is substantially longer than Ga-68 and F-18, which may enable centralized production, longer shelf life, and greater flexibility in clinical scheduling for PET diagnostics.

The LinkedIn post also points to emerging clinical data, citing a 2026 European Urology study evaluating Cu-64 SAR-bisPSMA in prostate cancer that reportedly showed a higher lesion detection rate versus Ga-68 PSMA-11. This suggests a potential competitive advantage for Cu-64–based imaging agents in prostate cancer diagnostics, which could enhance the attractiveness of Cu-64 supply and CDMO partnerships for biopharma developers.

On the manufacturing side, the post highlights what the company describes as a differentiated position built around a proprietary Ni-64 in-house recycling process with up to a 90% recovery rate, supporting multi-batch operation and lower raw material costs. Current batch capacity reportedly exceeds 2 Ci after end of bombardment, with integrated radiolabeling, formulation, fill-finish, and cold-chain distribution presented as part of the offering.

For investors, the activation of the DMF and the highlighted manufacturing capabilities could indicate that C Ray Therapeutics is positioning itself as a specialized CRDMO partner in the radiopharmaceutical and theranostics value chain. If the company can convert this regulatory and technical platform into long-term Cu-64 supply and development contracts, it may create recurring revenue opportunities tied to the growth of PET diagnostics and theranostic programs.

The post further notes that C Ray Therapeutics plans to engage with potential partners at upcoming industry conferences, including ANZSNM 2026 in Canberra and SNMMI 2026 in Los Angeles. Increased visibility at these events could support business development efforts, potentially expanding the company’s pipeline of IND- and NDA-stage collaborations and reinforcing its position within the nuclear medicine and theranostics market.