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Clarity Pharmaceuticals Accelerates Prostate Cancer Imaging with FDA Fast Track Nod

7:03pm on Monday 2nd of June, 2025 AEST Healthcare
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Clarity Pharmaceuticals Accelerates Prostate Cancer Imaging with FDA Fast Track Nod

7:03pm on Monday 2nd of June, 2025 AEST
Key Points
  • FDA grants second Fast Track Designation for 64Cu-SAR-bisPSMA targeting biochemical recurrence of prostate cancer
  • 64Cu-SAR-bisPSMA offers superior lesion detection and next-day imaging flexibility compared to current PSMA PET agents
  • Phase III AMPLIFY trial set to commence soon, pivotal for FDA approval
  • Potential to capture a growing US$3 billion prostate cancer diagnostic market by 2029
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