Clarity Locks in Third US Copper-64 Plant to Feed Commercial Scale Launch
Key Takeaways
Clarity Pharmaceuticals (ASX: CU6) has secured a major Clarity Pharmaceuticals Theragenics Copper-64 Agreement, adding a 14-cyclotron Atlanta facility capable of 28,000 daily patient doses to its growing US manufacturing network ahead of anticipated FDA approval.
- Clarity Pharmaceuticals has signed a manufacturing supply agreement with Theragenics effective 25 March 2026, making Theragenics its third major US copper-64 manufacturing partner alongside SpectronRx and Nusano.
- Theragenics' 134,000 square foot Atlanta facility operates 14 cyclotrons, each capable of producing approximately 2,000 patient doses per day, providing a theoretical combined capacity of 28,000 doses per day.
- Copper-64's 12.7-hour half-life delivers a 48-hour shelf life for 64Cu-SAR-bisPSMA, enabling centralised manufacturing and broad geographic distribution unlike short half-life competitors gallium-68 and fluorine-18.
- The Phase III AMPLIFY trial has reached its target enrolment and the CLARIFY trial is ongoing, with three FDA Fast Track Designations secured to support an accelerated regulatory pathway.
Clarity Pharmaceuticals (ASX: CU6) has announced a large-scale manufacturing supply agreement for copper-64 with Theragenics, effective 25 March 2026. The agreement positions the clinical-stage radiopharmaceutical company to support anticipated commercial-scale production of its lead diagnostic product, 64Cu-SAR-bisPSMA, ahead of US Food and Drug Administration (FDA) approval following completion of its Phase III registrational trials.
The agreement secures access to Theragenics’ 134,000 square foot production facility near Atlanta, Georgia, which operates a fleet of 14 cyclotrons and has 40 years of radiometal production experience. Each cyclotron is capable of producing approximately 100Ci (3.7 TBq) of copper-64 per day, translating to around 2,000 patient doses per day per cyclotron at 200 MBq per dose with a 48-hour shelf life.
Clarity Pharmaceuticals secures major copper-64 manufacturing deal with Theragenics
The manufacturing supply agreement represents a strategic step in building commercial readiness for 64Cu-SAR-bisPSMA, the company’s lead diagnostic candidate currently in Phase III clinical trials. Theragenics brings substantial credentials to the partnership, with four decades of routine radiometal production and considerable experience in manufacturing radioisotopes for medical use.
Atlanta’s position as a major US transport hub supports Theragenics’ centralised manufacturing model, enabling broad geographic distribution of copper-64 to clinical sites across the country. The facility’s fleet of high-current cyclotrons provides large-scale production capacity designed to support commercial demand across multiple large oncology indications.
The agreement is effective as of 25 March 2026, with cancellation and extension provisions aligned with industry standard rates. This timing aligns with Clarity’s clinical programme momentum, as the company advances toward completion of its AMPLIFY and CLARIFY Phase III registrational trials with 64Cu-SAR-bisPSMA.
Mark Pugh, CEO of Theragenics
“We are excited to enter into this Manufacturing Supply Agreement for copper-64 with Clarity. Having a current commercial sales force in prostate cancer, we have a deep insight into this field and have seen the excitement from key opinion leaders around 64Cu-SAR-bisPSMA. This agreement continues our expansion into the contract manufacturing organisation (CMO) isotope market, and we see Clarity as an ideal partner to advance this vision.”
Building a nationwide copper-64 supply network
The manufacturing supply agreement establishes Theragenics as the third major US manufacturing partner for Clarity, joining existing supply agreements with SpectronRx and Nusano. This multi-partner network spans distinct US geographies, creating a distributed manufacturing infrastructure designed to provide secure, abundant supply of copper-64 for commercial-scale demand.
The network approach aims to support multiple large oncology indications beyond prostate cancer, with manufacturing sites strategically positioned to enable broad distribution whilst maintaining supply security. Clarity’s multi-tiered service model combines large, local, centralised manufacturing facilities with extensive geographic reach.
Theragenics’ expertise in commercial radiometal production and existing presence in the prostate cancer market through its brachytherapy business provides additional strategic value to the partnership. The company’s current commercial sales force offers insight into the prostate cancer field and physician perspectives on diagnostic imaging needs.
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Why copper-64’s half-life gives Clarity a commercial edge
Copper-64’s physical properties create distinct commercial advantages compared to radioisotopes currently used in prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging. The isotope has a half-life of 12.7 hours, significantly longer than the less than 2 hours for gallium-68 and fluorine-18, the radionuclides currently used in PSMA PET diagnostics.
Half-life refers to the time it takes for half of a radioactive substance to decay. A longer half-life means the isotope remains active and usable for a longer period after production. This translates into a shelf-life of up to 48 hours for 64Cu-SAR-bisPSMA, compared to severely limited shelf-life for products based on gallium-68 and fluorine-18.
The extended half-life enables greater flexibility for supply logistics and patient scheduling. Short half-life isotopes typically require on-site cyclotron production or immediate proximity to manufacturing facilities, limiting accessibility and creating scheduling constraints. Copper-64’s 12.7-hour half-life overcomes these limitations, allowing centralised manufacturing with distribution to multiple clinical sites.
| Isotope | Half-Life | Practical Shelf-Life | Distribution Flexibility |
|---|---|---|---|
| Copper-64 | 12.7 hours | Up to 48 hours | Centralised, broad reach |
| Gallium-68 | Less than 2 hours | Limited | On-site production required |
| Fluorine-18 | Less than 2 hours | Limited | On-site production required |
This represents what Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, described as “a unique opportunity to implement a multi-tiered service approach comprising of large, local, centralised manufacturing with broad geographic distribution.” The model aims to avoid what he characterised as “the excessive costs, waste and inefficiencies associated with the supply and manufacture of short half-life isotopes.”
The commercial implications extend to scalability and profitability potential. Centralised manufacturing eliminates the need for expensive on-site cyclotrons at every imaging facility, potentially reducing infrastructure costs whilst expanding access. The extended shelf-life also reduces waste from unused doses that expire before administration.
Phase III progress positions Clarity for commercial launch
The manufacturing supply agreement aligns with significant clinical and regulatory momentum for 64Cu-SAR-bisPSMA. The company recently announced achieving its target number of participants in the Phase III AMPLIFY trial, months after imaging the first patient. The Phase III CLARIFY trial continues to progress.
Clarity has secured three Fast Track Designations (FTDs) from the US FDA for 64Cu-SAR-bisPSMA, supporting an accelerated regulatory pathway. Fast Track Designation is granted to therapies addressing serious conditions and demonstrating potential to address unmet medical needs. The designation facilitates more frequent FDA interactions and potentially expedited review of marketing applications.
Recent clinical data presented at the EAU Annual Congress 2026 from the head-to-head Co-PSMA investigator-initiated trial has been accepted for publication in the European Urology Journal. This growing body of scientific evidence supports the clinical development programme as it advances toward completion.
Key clinical and regulatory milestones include:
- Phase III AMPLIFY trial reached target enrolment
- Phase III CLARIFY trial ongoing
- Three FDA Fast Track Designations secured
- Co-PSMA head-to-head data presented at EAU 2026
Executive confidence in commercial readiness
Dr Alan Taylor emphasised the company’s proximity to commercialisation in his commentary on the Theragenics agreement. He noted that Clarity is “closer than ever to commercialisation of 64Cu-SAR-bisPSMA” based on recent clinical data and trial progress.
The manufacturing strategy is now “coming into play,” according to Dr Taylor, as the company builds infrastructure to support commercial launch and market expansion subject to FDA approval. He stated the team remains “committed to continue working closely with our vendors, clinicians, participating clinical trial sites, regulatory agencies and supply and manufacturing facilities to get 64Cu-SAR-bisPSMA to patients in need as soon as possible, at scale to meet the future demand.”
Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals
“Building out a secure, reliable and abundant supply and manufacturing strategy is now coming into play, ensuring a solid base for our commercial launch and accelerated market expansion, subject to FDA approval. Our goal is to take the industry in a new direction of scalability and profitability while delivering universal access to radiodiagnostics for physicians and the patients they serve.”
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What this means for Clarity’s investment case
The manufacturing supply agreement addresses a critical commercial infrastructure requirement ahead of anticipated product approval. With three manufacturing partners now secured across distinct US geographies, Clarity has established a foundation for commercial-scale supply that mitigates single-source manufacturing risk.
The production capacity secured through the agreement is substantial. With 14 cyclotrons each capable of producing approximately 2,000 patient doses per day, Theragenics’ facility alone could theoretically support 28,000 doses per day at full capacity. This scale positions Clarity to support multiple oncology indications beyond prostate cancer, subject to clinical trial success and regulatory approval.
Copper-64’s logistics advantages create potential differentiation in the radiopharmaceutical market. The ability to implement centralised manufacturing rather than requiring on-site cyclotrons at every imaging facility may provide cost advantages compared to short half-life competitors. The extended shelf-life reduces waste and scheduling constraints, potentially improving both economics and physician adoption.
Key investment takeaways include:
- Third major US copper-64 manufacturing partner secured alongside SpectronRx and Nusano
- 14-cyclotron facility capable of approximately 2,000 patient doses per day per cyclotron
- Phase III trials advancing toward completion with target enrolment achieved in AMPLIFY
- Commercial launch preparation underway pending FDA approval following successful trial completion
The company noted that 64Cu-SAR-bisPSMA is an unregistered product whose safety and efficacy have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee the product will become commercially available. Commercial launch remains subject to successful completion of Phase III registrational trials and subsequent FDA New Drug Application (NDA) approval.
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