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- Ionetix Corporation has become the first commercial drug manufacturer to receive FDA approval for an Abbreviated New Drug Application for Gallium Ga-68 gozetotide, a radioactive diagnostic agent for prostate cancer imaging. - The approved agent enables PSMA-PET scanning in men with prostate cancer who have suspected metastasis or recurrence based on elevated PSA levels. - The approval allows Ionetix to expand access to this diagnostic tool through its multi-site network of PET facilities, particularly targeting underserved areas. - The product is supplied as a single-dose injection with a three-hour expiration period and represents an expansion of Ionetix's portfolio in positron emission tomography diagnostics.
- Cellectar Biosciences announced a strategic multi-year supply agreement with Ionetix Corporation for clinical and commercial-scale production of Actinium-225 and Astatine-211 radioisotopes. - The agreement supports development of CLR-225, a phospholipid radioconjugate targeting challenging solid tumors including pancreatic cancer, advancing the company's targeted alpha therapy pipeline. - Ionetix is installing a second cyclotron at its Michigan facility to meet growing demand, with dedicated production lines for each alpha-emitting isotope. - The collaboration leverages Cellectar's proprietary phospholipid ether platform technology, which delivers isotopes directly to tumor cells while sparing healthy tissue.
