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Highlights

  • Clarity Pharmaceuticals jumps 10% to $2.36 following major clinical trial milestone.

  • First patient imaged in AMPLIFY Phase III trial for next-gen prostate cancer diagnostic.

  • Company targets FDA approval with 64Cu-SAR-bisPSMA to tap into a vast global market.

Shares of Clarity Pharmaceuticals Ltd (ASX: CU6) rallied 10% to $2.36 on Thursday morning after the company announced it had successfully imaged the first patient in its Phase III AMPLIFY trial — a critical milestone in its quest to commercialise a breakthrough prostate cancer diagnostic.

The AMPLIFY trial is evaluating 64Cu-SAR-bisPSMA, Clarity’s next-generation PET/CT imaging agent designed to detect prostate cancer recurrence earlier and with greater precision than current technologies. The trial marks a crucial step towards U.S. Food and Drug Administration (FDA) approval and eventual market launch.

First Patient Imaged in Registrational Study

The first patient was scanned at XCancer in Omaha, Nebraska, just over a week after study initiation. The trial will enrol approximately 220 patients across sites in the United States and Australia.

Dr Luke Nordquist, Urologic Medical Oncologist and CEO of XCancer, highlighted the importance of the trial:

“64Cu-SAR-bisPSMA could become a best-in-class diagnostic agent. We are honoured to be part of this registrational trial aimed at supporting a New Drug Application and the commercialisation of this next-generation product.”

Addressing a Growing Global Health Challenge

Clarity's announcement also underscores the growing prevalence of prostate cancer, a disease that remains the second most common cancer in men globally. According to the American Cancer Institute, 2025 is projected to see approximately 313,780 new prostate cancer cases and 35,770 related deaths in the U.S. alone.

Dr Taylor emphasised the pressing need for better diagnostics:

“With prostate cancer cases rising each year, our mission is to overcome the limitations of current detection methods and offer earlier, more accurate diagnosis — especially in underserved regional areas.”