C-Ray receives FDA active status for Cu-64 DMF

C-Ray Therapeutics has received active status from the U.S. Food and Drug Administration for its Type II Drug Master File covering copper-64 chloride for radiolabeling.

The filing, listed as DMF No. 43568, is now available for reference by radiopharmaceutical developers in support of investigational new drug and new drug application submissions, according to the company.

The regulatory milestone gives developers a way to reference C-Ray’s Cu-64 chloride chemistry, manufacturing, and controls information rather than independently generating the same package for each submission. For companies developing Cu-64-labeled PET agents, that can reduce duplication, lower chemistry, manufacturing, and controls burden, and support more efficient regulatory planning.

Cu-64 has a half-life of about 12.7 hours, which is longer than gallium-68 at 68 minutes and fluorine-18 at 110 minutes. C-Ray said the longer half-life allows centralized production, shelf lives of up to 48 hours, and reduced scheduling pressure at imaging centers.

That logistics difference is important in PET imaging. Shorter-lived isotopes often require local or nearby production, which can limit access in smaller markets. A longer-lived diagnostic isotope may be easier to distribute regionally, giving imaging centers more flexibility in scheduling and potentially widening access to PET radiopharmaceuticals.

C-Ray also highlighted clinical data supporting Cu-64 imaging agents. The company cited a 2026 European Urologystudy of Cu-64 SAR-bisPSMA in prostate cancer that found Cu-64-labeled imaging detected more than twice as many lesions as Ga-68 PSMA-11. The reported positive detection rate was 78% with Cu-64 SAR-bisPSMA versus 36% with Ga-68 PSMA-11.

The company’s manufacturing platform includes an in-house nickel-64 recycling process with a recovery rate of up to 90%. C-Ray said this allows recovered high-enrichment Ni-64 to be reused in later production cycles, supporting multibatch operation and reducing raw material costs. Current batch capacity exceeds 2 Ci at end of bombardment.

“FDA acceptance of our Cu-64 Type II DMF marks a significant milestone,” said Qiao Haitao, general manager of C-Ray Therapeutics.

C-Ray also said it offers radiolabeling and conjugation, formulation and fill-finish, and cold-chain distribution services. That positions the company as a supply and development partner for radiopharmaceutical developers working from early clinical development through later-stage production.

The filing does not itself approve a specific imaging drug. Instead, it supports developers that need a compliant Cu-64 chloride supply source for PET diagnostic agents. The practical impact will depend on how many companies reference the DMF in clinical and commercial submissions, and how quickly Cu-64-based imaging agents continue to move through development.