(Clarity Pharmaceuticals: Eveleigh, Australia) -- Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, has signed a large-scale manufacturing supply agreement for copper-64 with Theragenics.

The agreement relates to Theragenics’ 134,000 sq ft production facility with a fleet of 14 cyclotrons close to Atlanta, a major U.S. transport hub, for centralized, large-scale copper-64 (Cu-64 or 64Cu) production ahead of anticipated 64Cu-SAR-bisPSMA commercial launch upon successful completion of Clarity’s Phase III registrational trials with this product, AMPLIFY¹ and CLARIFY², as well as subsequent U.S. Food and Drug Administration (FDA) New Drug Application (NDA) approval.

Theragenics has substantial cyclotron expertise with 40 years of routine radiometal production and considerable experience in producing radioisotopes for medical use. Combined with a sizeable fleet of high-current cyclotrons, this constitutes an opportunity for large-scale copper-64 manufacturing at the site. Theragenics has capacity to produce about 100Ci (3.7 TBq) of copper-64 per day on a single cyclotron, which translates to about 2,000 patient doses per day on each cyclotron at 200 MBq per dose with a 48-hour shelf life.

Together with Clarity’s existing copper-64 supply agreements with SpectronRx and Nusano, this agreement with Theragenics further enhances Clarity’s broad network of high-volume copper-64 manufacturers in distinct U.S. geographies. The network is designed to support commercial-scale demand across multiple large oncology indications with secure, seamless, and abundant supply of this diagnostic isotope, made possible with the 12.7-hour half-life of copper-64, which is unique in the radiopharmaceutical commercial space.

“We are excited to enter into this manufacturing supply agreement for copper-64 with Clarity,” says Mark Pugh, CEO of Theragenics. “Having a current commercial sales force in prostate cancer, we have 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 organization (CMO) isotope market, and we see Clarity as an ideal partner to advance this vision. Clarity is in a unique position with two diagnostic Phase III trials nearing completion, three Fast Track Designations (FTDs) from the FDA, and impressive data generated to date. With our core expertise and experience in producing radiometals for commercial medical purposes at Theragenics, together we can expand access to radiopharmaceuticals and bring a next-generation platform to patients in need of better diagnostics in the U.S.”

Alan Taylor, executive chairperson of Clarity Pharmaceuticals, says, “Clarity is closer than ever to commercialization of 64Cu-SAR-bisPSMA, with outstanding data recently released from the head-to-head Co-PSMA investigator-initiated trial³ and our announcement on achieving our target number of participants in the Phase III AMPLIFY trial just months since imaging the first patient⁴.

“The growing body of scientific evidence, along with the FTDs from the FDA, are providing great momentum for 64Cu-SAR-bisPSMA. 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 team is 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.

“The longer half-life of copper-64 (12.7 hours vs. less than 2 hours for the radionuclides currently used in prostate-specific membrane antigen [PSMA] positron emission tomography [PET], i.e., gallium-68 and fluorine-18) translates into a shelf life of up to 48 hours for 64Cu-SAR-bisPSMA. As such, copper-64 offers greater flexibility for supply and scheduling of patients, overcoming various limitations of the short half-life isotopes currently used in radiodiagnostics. This represents a unique opportunity to implement a multitiered service approach comprising large, local, centralized manufacturing with broad geographic distribution. Importantly, we have the opportunity to avoid the excessive costs, waste, and inefficiencies associated with the supply and manufacture of short half-life isotopes. 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.

“Theragenics has decades of experience in the commercial production of radiometals for medical purposes and valuable insight into the prostate cancer field based on its existing brachytherapy business. We look forward to working with them as we prepare to take the next steps in our development.”

The manufacturing supply agreement is effective March 25, 2026. Cancellation and extension provisions are aligned with industry standard rates.

Disclaimer

64Cu-SAR-bisPSMA is an unregistered product. Its safety and efficacy have not been assessed by health authorities such as the FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available.

References
1. ClinicalTrials.gov Identifier: NCT06970847. https://clinicaltrials.gov/study/NCT06970847.

2. ClinicalTrials.gov Identifier: NCT06056830. https://clinicaltrials.gov/study/NCT06056830.

3. Clarity Pharmaceuticals. Co-PSMA data presented at EAU Annual Congress 2026 with manuscript accepted for publication in the European Urology Journal:  https://www.claritypharmaceuticals.com/news/co-psma-eau/.

4. Clarity Pharmaceuticals. Registrational Phase III AMPLIFY trial: Target number of participants achieved: https://www.claritypharmaceuticals.com/news/amplify_target_achieved/.