• Oral presentation on Co-PSMA trial results at EAU Congress 2026
• Co-PSMA data accepted for publication in European Urology journal
• 64Cu-SAR-bisPSMA demonstrated superior diagnostic performance over 68Ga-PSMA-11

Clarity Pharmaceuticals announced that the results from the Co-PSMA (NCT06907641) Investigator-Initiated Trial were presented at the European Association of Urology (EAU) Congress 2026 and accepted for publication in the prestigious European Urology journal. The Co-PSMA trial evaluated the performance of Clarity's 64Cu-SAR-bisPSMA diagnostic product in a head-to-head comparison to the standard-of-care 68Ga-PSMA-11 in 50 patients with biochemical recurrence of prostate cancer and low PSA levels (0.2 - 0.75 ng/mL). The primary endpoint was to assess the difference in mean per-patient lesion number, with 64Cu-SAR-bisPSMA (24-hour imaging) demonstrating a significantly higher mean lesion count compared to 68Ga-PSMA-11 (1.26 vs. 0.48, respectively). 64Cu-SAR-bisPSMA also identified a greater total number of lesions (63 vs. 24) and resulted in a higher number of participants with a positive scan (78% vs. 36%). Additionally, 64Cu-SAR-bisPSMA showed a higher true positive rate (71% vs. 29%) and lower false negative rate (21% vs. 65%) than 68Ga-PSMA-11. The 64Cu-SAR-bisPSMA scans led to a change in management in 44% of trial participants. These results, combined with data from the Phase II COBRA trial and the anticipated Phase III AMPLIFY study, are intended to be submitted to the FDA for market authorization of 64Cu-SAR-bisPSMA in prostate cancer patients with biochemical recurrence.

Clarity Pharmaceuticals is focused on advancing its SAR-bisPSMA program, including the ongoing Phase III AMPLIFY and CLARIFY trials, to seek regulatory approval for 64Cu-SAR-bisPSMA in prostate cancer patients with biochemical recurrence.