The U.S. Food and Drug Administration (FDA) has granted Clarity Pharmaceuticals fast-track designation for its copper-64 (Cu-64) sarcophagine (SAR) bisPSMA radiopharmaceutical.
The company is investigating the potential of Cu-64 SAR-bisPSMA for PET imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions for men with suspected metastasis who are candidates for initial definitive therapy.
Clarity's ongoing clinical program with Cu-64 SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence of their disease.
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