Clarity Pharmaceuticals wins FDA breakthrough designation for Cu-64 SAR-bisPSMA prostate cancer imaging agent

• Clarity Pharmaceuticals received FDA Breakthrough Therapy designation for Cu-64 SAR-bisPSMA imaging in suspected recurrent prostate cancer on Nov. 12, 2026.
• The first such designation in PSMA PET imaging provides intensive FDA guidance to accelerate development and review.
• Co-PSMA and COBRA trial data, supported by real-world evidence, indicated better detection of recurrent prostate cancer than standard-of-care PSMA PET imaging.
• Co-PSMA results were already presented at European urology and nuclear medicine congresses, supporting the designation.
• Registrational Phase III trials AMPLIFY and CLARIFY completed recruitment, with topline results expected in the first half of 2027 to support FDA applications.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clarity Pharmaceuticals Ltd. published the original content used to generate this news brief on November 12, 2026, and is solely responsible for the information contained therein.