Clarity signs commercial-scale copper-64 Supply Agreement

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Stock Clarity Pharmaceuticals Ltd (CU6.ASX)
Release Time 17 Apr 2025, 9:55 a.m.
Price Sensitive Yes
 Clarity signs high-volume commercial-scale copper-64 Supply Agreement
Key Points
  • Clarity signs commercial-scale agreement with Nusano for supply of copper-64
  • Nusano facility capable of producing over 1,000 Ci of copper-64 per day
  • Supply will complement Clarity's existing network of US-based suppliers
Full Summary

Clarity Pharmaceuticals (ASX: CU6) has signed a commercial-scale Supply Agreement with Nusano, Inc. for the supply of copper-64 (Cu-64 or 64Cu) isotope. Nusano's 190,000 square foot state-of-the-art facility in West Valley City, Utah is expected to begin production in 2025 with copper-64 isotope supply planned to commence in early 2026. The accelerator-based proprietary technologies employed by Nusano are particularly well suited for cost-effective mass production of copper-64. The Nusano facility is capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity, which translates into more than 18,000 patient doses per day at 200 MBq per dose, with a 48-hour shelf-life, well in excess of commercial-scale demands across multiple large oncology indications. Nusano is also developing in-house production of the target material for copper-64 manufacturing, nickel-64 (Ni-64), and plans to commence production of copper-67 (Cu-67 or 67Cu) and actinium-225 (Ac-225 or 225Ac) isotopes in 2025-2026, both of which are used in Clarity's pipeline of theranostic products in development. The signing of this Supply Agreement with Nusano will complement Clarity's existing network of US-based copper-64 suppliers, providing capacity to ensure abundant and seamless supply of the isotope as the company is generating exceptional data in a number of late-stage clinical trials and approaches the filing of New Drug Applications (NDA) with the US Food and Drug Administration (FDA) for the commercial roll-out of its Targeted Copper Theranostics (TCTs) in the US market.

Guidance

Clarity is progressing a number of late-stage clinical trials and fast approaching commercialization. The company aims to file New Drug Applications (NDA) with the US FDA for the commercial roll-out of its Targeted Copper Theranostics (TCTs) in the US market.

Outlook

Clarity is determined to overcome the limitations of the current generation of radio-diagnostics and lay a strong foundation for the successful roll-out of its TCTs globally. The company's goal is to take radiopharmaceuticals to the next level by building a reliable and accessible supply that is consistent with the big pharma oncology model and deliver advantages to patients, their treating clinicians and imaging sites.