C Ray Therapeutics advanced its position in radiopharmaceuticals this week as the U.S. FDA activated its Type II Drug Master File for Cu-64 (DMF No. 43568), allowing global IND and NDA filers to reference the dossier. The Cu-64 isotope’s 12.7-hour half-life supports centralized production, up to 48-hour shelf life, and more flexible PET imaging logistics versus Ga-68 and F-18.
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Emerging data cited by the company, including a 2026 European Urology study, indicate Cu-64 SAR-bisPSMA may deliver higher lesion detection in prostate cancer than Ga-68 PSMA-11, underscoring the clinical potential of Cu-64–based agents. This performance profile could make C Ray’s Cu-64 platform more attractive for supply and CDMO partnerships in oncology diagnostics.
Operationally, C Ray highlighted a proprietary Ni-64 recycling process with up to 90% recovery, multi-curie Cu-64 batch capacity above 2 Ci at end of bombardment, and integrated radiolabeling, formulation, fill-finish, and cold-chain distribution. The FDA-validated DMF and cGMP infrastructure from its Chengdu site position the firm as a CRDMO partner across more than 30 radioisotopes and over 100 programs, including Phase III assets.
The company also showcased its role in advancing radiopharmaceutical pipelines, providing clinical materials and CRO services for assets such as Ac-225–RAX104, Cu-64–RAX301, and Lu-177–PSMA-3D1015. This service-centric model gives C Ray diversified exposure to multiple partners’ programs, reducing dependence on any single therapy while tapping rising demand in radiotheranostics.
Industry commentary from AACR 2026 pointed to growing momentum for alpha emitters like Ac-225 and Pb-212 and an expanding target set beyond PSMA and SSTR2, trends that align with C Ray’s specialization in high-value isotopes. The company reports more than 100 completed CRDMO projects, including 23 involving Ac-225 labeling and two programs that have progressed to Phase III development.
C Ray plans active business development at ANZSNM 2026 in Canberra and SNMMI 2026 in Los Angeles, where it will promote development partnerships, isotope pilot projects, and clinical manufacturing collaborations. Overall, the week marked a strategic inflection as regulatory validation of Cu-64 capabilities and growing conference visibility reinforced the firm’s role as an emerging global radiopharmaceutical supply and development partner.