Clarity Pharmaceuticals (ASX:CU6), an Australia-based clinical-stage radiopharmaceutical company, announced on Tuesday that it has entered into a commercial manufacturing agreement with SpectronRx for Clarity's lead diagnostic product, 64Cu-SAR-bisPSMA.

Under the agreement SpectronRx's facility in Indiana will provide on-demand commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA under one roof and enable distribution to all 50 US states. It can produce up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually from the one facility.

Clarity says that together with other supply and manufacturing deals, this agreement substantially bolsters reliable, universal access to 64Cu-SAR-bisPSMA in the United States for a commercial rollout upon successful completion of Phase III registrational trials and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.

The commercial supply agreement is effective as of 17 June 2025, and is for an initial period of five years. Cancellation and extension provisions are aligned with industry standard rates.