19 February 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for 67Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been previously treated with androgen receptor pathway inhibition.

This milestone builds on Clarity's earlier receipt of two fast track designations for the diagnostic 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy, as well as patients with biochemical recurrence of prostate cancer following definitive therapy, with 2 Phase 3 registration trials underway (CLARIFY and AMPLIFY, respectively).

Read Clarity Pharmaceuticals press release