Highlights

• The US Food and Drug Administration has granted 64Cu-SAR-bisPSMA its first-ever Breakthrough Therapy Designation in PSMA PET imaging, covering men with suspected biochemical recurrence of prostate cancer.

• Clinical data from the Phase II Co-PSMA and Phase I/II COBRA trials supported the designation, demonstrating meaningfully improved diagnostic performance over the standard-of-care PSMA PET agents.

• Both registrational Phase III trials — AMPLIFY and CLARIFY — have completed recruitment and are now in patient follow-up, with topline data anticipated in the first half of 2027.

• Breakthrough Therapy designation brings intensive FDA guidance, senior organisational commitment, and potential eligibility for Priority Review at the time of the New Drug Application.

Clarity Pharmaceuticals (ASX:CU6), a clinical-stage radiopharmaceutical company developing Targeted Copper Theranostics and listed on the Australian Securities Exchange under the ticker CU6, announced on 12 November 2026 that the United States Food and Drug Administration had granted Breakthrough Therapy designation to its lead product, 64Cu-SAR-bisPSMA, for use in positron emission tomography imaging of PSMA-positive lesions in men with prostate cancer and suspected biochemical recurrence. The designation is historically significant, representing the first time the FDA has granted this status to any product in the PSMA PET imaging category — a distinction that the company's executive chairperson noted was further amplified by the fact that fewer than half of all Breakthrough Therapy designation requests across all therapeutic areas are ultimately successful. Breakthrough Therapy designation is intended for drugs that show preliminary clinical evidence of substantial improvement over currently available therapies in serious conditions and is associated with an expedited development and review process, intensive FDA guidance, and senior organisational engagement from the regulator.

Significance of the Breakthrough Therapy Designation

The FDA's decision was supported by data from two clinical studies conducted with 64Cu-SAR-bisPSMA: the Phase II Co-PSMA trial and the Phase I/II COBRA trial. The Co-PSMA study employed a head-to-head, intra-patient comparison design against the standard-of-care PSMA PET agent, 68Ga-PSMA-11, in patients with biochemical recurrence following radical prostatectomy. The study found that 64Cu-SAR-bisPSMA detected prostate cancer recurrence in a substantially higher proportion of patients than the comparator, including among patients with lower PSA levels where existing products frequently miss disease. Beyond raw detection rates, the study found that the imaging results led clinicians to modify their planned treatment approaches in a meaningful proportion of patients, underscoring the potential Downstream clinical impact of improved diagnostic accuracy on actual treatment decisions. The COBRA study further demonstrated the product's ability to detect lesions in patients who had already tested negative or equivocal on standard imaging, adding an important dimension to the evidence base. The SAR Technology that underpins Clarity's platform is designed to prevent copper isotopes from leaking from their chelating structure, enabling extended imaging timepoints of up to 30 hours post-injection — a characteristic that contributes to the product's enhanced diagnostic performance relative to shorter half-life PSMA PET agents.

Clinical Evidence Underpinning the Designation

With the Breakthrough Therapy designation now secured, attention turns to the two registrational Phase III trials underway in both the United States and Australia. The AMPLIFY trial, enrolling participants with elevated PSA levels following definitive therapy for prostate cancer, and the CLARIFY trial, enrolling participants with high-risk disease prior to radical prostatectomy, have both completed recruitment and are now in patient follow-up phases. Topline data from both studies is anticipated in the first half of 2027. The trials are registrational in nature, meaning their results are designed to provide sufficient evidence to support a New Drug Application to the FDA. The Breakthrough Therapy designation also makes the product a potential candidate for Priority Review at the time of that application, which could shorten the FDA's standard review timeline and accelerate the path to commercialisation if the pivotal trial results are favourable.

Phase III Trial Progress and Path to Market

The convergence of a historic regulatory milestone and the near-term availability of pivotal trial data places Clarity Pharmaceuticals at a significant inflection point in its development trajectory. PSMA PET imaging has grown rapidly in clinical adoption globally, becoming an important diagnostic tool in both initial staging and the biochemical recurrence setting for prostate cancer, the second most common cancer diagnosed in men worldwide. Clarity's focus on improving upon existing approved agents by addressing the detection gaps that remain at lower PSA levels represents a clinically relevant differentiation that the FDA's designation process has now formally recognised as potentially meaningful. For the broader field of theranostics, where diagnostic imaging and targeted therapy are increasingly paired around the same molecular target, the advancement of a highly specific copper-based imaging agent toward registration is a noteworthy development with potential implications beyond prostate cancer. Investors monitoring Clarity Pharmaceuticals should understand that radiopharmaceuticals, while a relatively specialised segment of the broader pharmaceutical market, have attracted increasing interest from large industry participants as the therapeutic and diagnostic value of targeted radioligand agents has become more evident in clinical practice. The convergence of Clarity's proprietary SAR Technology, the diagnostic advantage demonstrated in clinical studies relative to existing approved agents, and the now-secured Breakthrough Therapy designation creates a combination of factors that is likely to sustain investor and industry attention as the company approaches the pivotal trial data readout period. The company's focus on copper-64 for imaging and copper-67 for therapy — using the same targeting vector — also positions it as a participant in the emerging theranostics field, where the same molecular agent can be adapted for both disease detection and treatment, a paradigm that is gaining traction across oncology.

Key Insights

The convergence of a historic regulatory milestone and the near-term availability of pivotal trial data places Clarity Pharmaceuticals at a significant inflection point in its development trajectory. PSMA PET imaging has grown rapidly in clinical adoption globally, becoming an important diagnostic tool in both initial staging and the biochemical recurrence setting for prostate cancer, the second most common cancer diagnosed in men worldwide. Clarity's focus on improving upon existing approved agents by addressing the detection gaps that remain at lower PSA levels represents a clinically relevant differentiation that the FDA's designation process has now formally recognised as potentially meaningful. For the broader field of theranostics, where diagnostic imaging and targeted therapy are increasingly paired around the same molecular target, the advancement of a highly specific copper-based imaging agent toward registration is a noteworthy development with potential implications beyond prostate cancer. Investors monitoring Clarity Pharmaceuticals should understand that radiopharmaceuticals, while a relatively specialised segment of the broader pharmaceutical market, have attracted increasing interest from large industry participants as the therapeutic and diagnostic value of targeted radioligand agents has become more evident in clinical practice. The convergence of Clarity's proprietary SAR Technology, the diagnostic advantage demonstrated in clinical studies relative to existing approved agents, and the now-secured Breakthrough Therapy designation creates a combination of factors that is likely to sustain investor and industry attention as the company approaches the pivotal trial data readout period. The company's focus on copper-64 for imaging and copper-67 for therapy — using the same targeting vector — also positions it as a participant in the emerging theranostics field, where the same molecular agent can be adapted for both disease detection and treatment, a paradigm that is gaining traction across oncology.