Clarity touts FDA fast track designation

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.