Clarity Pharmaceuticals wins FDA breakthrough designation for 64Cu-SAR-bisPSMA

Clarity Pharmaceuticals (ASX:CU6) received a US Food and Drug Administration breakthrough therapy designation for 64Cu-SAR-bisPSMA to detect recurring prostate cancer across an estimated 333,830 annual US cases.

The agency awarded this status for the first time in prostate-specific membrane antigen imaging history after clinical data showed improved detection over standard-of-care scans.

"The FDA's award of the first breakthrough therapy designation in the history of PSMA PET imaging highlights the unmet need for more accurate detection of recurrent prostate cancer lesions and the significance of the data generated to date, which indicates improved diagnostic performance of 64Cu-SAR-bisPSMA compared to standard of care PSMA PET in patients with BCR of prostate cancer," said Clarity Pharmaceuticals Executive Chair Dr Alan Taylor.

Clarity expects topline results from its completed Phase 3 Amplify and Clarify trials before mid-2027 to support a formal US approval application.

Following the announcement, the Clarity Pharmaceuticals share price was up at $2.05.

The company targets a US prostate cancer imaging market that generates approximately US$2.92 billion in annual sales and is projected by estimates to exceed US$4.38 billion by 2029.

Clarity develops radiopharmaceuticals using its proprietary sarcophagine technology, which traps copper isotopes inside a cage-like structure to prevent bodily leakage during targeted cancer imaging and therapy.