Sydney, Australia | April 14, 2026

Clarity Pharmaceuticals has announced the signing of a Commercial Manufacturing Agreement with Nucleus RadioPharma for the production of 64Cu-SAR-bisPSMA, a next-generation radiopharmaceutical imaging agent targeting prostate cancer. This strategic agreement marks a critical step toward the anticipated commercial launch of the product, which is currently advancing through Phase III registrational trials, including AMPLIFY and CLARIFY. The partnership is expected to significantly enhance manufacturing scale, distribution capacity, and patient access, positioning Clarity at the forefront of precision oncology and theranostics innovation.

Expanding Manufacturing Capacity for Commercial Readiness

Under the agreement, manufacturing will be supported by Nucleus RadioPharma’s advanced facilities in Rochester, Minnesota, capable of producing approximately 50,000 patient doses annually, along with a future 47,000-square-foot facility in Pennsylvania expected to deliver up to 600,000 doses per year. This large-scale infrastructure will enable nationwide distribution across the United States and extend access to international markets, including Europe.

The agreement builds upon an existing collaboration between the two companies, reinforcing a robust supply chain strategy designed to meet anticipated commercial demand. The integration of multiple production sites ensures consistent availability, logistical efficiency, and scalability, which are essential for radiopharmaceuticals with time-sensitive delivery requirements.

Next-Generation Imaging Agent Enhances Cancer Detection

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The investigational product, 64Cu-SAR-bisPSMA, is a targeted copper-based diagnostic imaging agent designed to detect prostate-specific membrane antigen (PSMA) expression in cancer cells. Early clinical data suggest that it may offer superior sensitivity in identifying small and previously undetectable lesions compared to standard-of-care PSMA PET imaging. This capability is crucial for early diagnosis, accurate staging, and improved treatment planning, directly impacting patient outcomes.

The use of copper-64, with its longer half-life, provides greater flexibility in centralized manufacturing and distribution models, allowing broader geographic reach and improved access for healthcare providers and patients. This innovation reflects the growing importance of theranostics, where diagnostic and therapeutic capabilities are integrated to enable personalized cancer care.

Strategic Impact on Radiopharmaceutical Market and Oncology Care

The agreement strengthens Clarity Pharmaceuticals’s position in the rapidly evolving radiopharmaceutical and theranostics market, which is gaining traction as a key segment within oncology. By establishing a tiered manufacturing network supported by multiple partners, including existing agreements with SpectronRx, Nusano, and Theragenics, the company is building a resilient and scalable production ecosystem.

This strategy is designed to support not only current demand but also a larger patient population that could benefit from improved diagnostic accuracy. Additionally, the collaboration with Nucleus RadioPharma brings together expertise in drug development, regulatory compliance, and commercial manufacturing, accelerating the transition from clinical trials to real-world application. The agreement underscores the importance of integrated supply chains and strategic partnerships in bringing advanced oncology solutions to market.

The Commercial Manufacturing Agreement between Clarity Pharmaceuticals and Nucleus RadioPharma represents a significant milestone in the journey toward commercializing next-generation prostate cancer imaging technologies. By combining innovative radiopharmaceutical development with large-scale manufacturing capabilities, the partnership aims to improve early detection, treatment planning, and overall patient outcomes. As the product progresses through late-stage clinical trials, this agreement lays the groundwork for a successful market entry and broader adoption of precision diagnostics in oncology.

Source: Clarity Pharmaceuticals press release