Australian clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) announced on Thursday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for the company's 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis which are candidates for initial definitive therapy.

Fast Track Designation is aimed at accelerating the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical requirements.

The company's ongoing clinical programme with 64Cu-SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence (BCR) of their disease.

Clarity's executive chair, Dr Alan Taylor, said: "Receiving Fast Track Designation for 64Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with this product. The designation will allow us to work closely with the FDA to facilitate the development process, potentially accelerating the approval of this best-in-class diagnostic."