Clarity Pharmaceuticals Gets FDA Breakthrough Therapy Designation for Prostate Cancer Imaging Agent

• Clarity Pharmaceuticals received FDA breakthrough therapy designation for Cu-64 SAR-bisPSMA imaging in men with suspected recurrent prostate cancer.
• The first such designation in PSMA PET imaging was supported by Co-PSMA, COBRA and real-world evidence.
• In Co-PSMA, Cu-64 SAR-bisPSMA detected cancer in 78% of participants, compared with 36% for Ga-68 PSMA-11.
• Registrational Phase III trials AMPLIFY and CLARIFY completed recruitment; patients remain in follow-up.
• Topline results from both trials are expected in the first half of 2027 to support an FDA application.

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 via PR Newswire (Ref. ID: 202611120901PR_NEWS_USPR_____CN96137) on November 12, 2026, and is solely responsible for the information contained therein.