Clarity Pharmaceuticals (ASX: CU6) has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its Cu-64 SAR-bisPSMA imaging agent. The designation covers positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
According to Executive Chairperson Dr Alan Taylor, the FDA’s award is the first Breakthrough Therapy designation in the history of PSMA PET imaging. It was supported by the Phase II Co-PSMA trial, the Phase I/II COBRA trial and real-world evidence, which collectively indicate enhanced diagnostic performance over standard-of-care (SOC) PSMA PET in biochemical recurrence (BCR).
Dr Alan Taylor, Executive Chairperson
“Receiving this Breakthrough Therapy designation is one of the most significant milestones in our prostate cancer program to date. Its importance is further amplified given fewer than half of designation requests across all therapeutic areas are successful…”
What Breakthrough Therapy designation delivers
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs intended to treat a serious condition. It applies where preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
The benefits of the designation include:
- All Fast Track designation features
- Intensive guidance on an efficient drug development program
- Organisational commitment from the FDA involving senior managers for a more proactive, collaborative, cross-disciplinary review
Fast Track designation can be granted on early-stage or nonclinical data. Breakthrough Therapy designation requires preliminary clinical evidence of a treatment effect.
The designation is also a positive indicator of potential eligibility for Priority Review, owing to overlapping qualifying criteria. Priority Review is requested at the time of the New Drug Application (NDA) submission and can substantially shorten the FDA’s review timeline.
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Data behind the designation
Co-PSMA head-to-head results
Co-PSMA was an investigator-initiated trial led by Prof Louise Emmett at St Vincent’s Hospital, Sydney. It enrolled 50 participants with a median PSA of 0.43 ng/mL, comparing Cu-64 SAR-bisPSMA against 68Ga-PSMA-11 in the same patients.
| Measure | 64Cu-SAR-bisPSMA (next-day) | 68Ga-PSMA-11 |
|---|---|---|
| Patient-level detection | 78% (39/50) | 36% (18/50) |
| Mean lesions per patient (primary endpoint, p < 0.0001) | 1.26 | 0.48 |
| Total lesions detected | 63 | 24 |
| Patient-level true positive rate | 71% | 29% |
| Active planned management | 90% | 66% |
Planned management changes were observed in 44% of patients following Cu-64 SAR-bisPSMA imaging. Agreement across three independent blinded readers was also higher for Cu-64 SAR-bisPSMA, with a Cohen’s Kappa of 0.94 versus 0.75 for 68Ga-PSMA-11.
The manuscript was selected as an Editor’s Choice article in European Urology, which has an impact factor of 29.7. The data were also presented at the European Association of Urology Congress and as a Top-Rated Oral Presentation at the European Association of Nuclear Medicine Congress 2026.
Investors exploring the peer-reviewed evidence in more detail can read our deep-dive into the European Urology publication, which examines the Co-PSMA lesion-level findings and the clinical impact on patient management decisions.
COBRA findings
COBRA was a Phase I/IIa study in participants with BCR of prostate cancer and negative or equivocal findings on SOC imaging. Fifty-two participants were enrolled and imaged, with 42 included in the efficacy calculations, and the median PSA at study entry was 0.9 ng/mL.
- The patient-level detection rate ranged from 58-80% on next-day imaging, compared with 44-58% on same-day imaging.
- Biopsies were performed in 9 patients, of whom 7 had a positive result based on histopathology.
- Investigators indicated they would change the treatment plan for 48% of patients.
The unmet need and Clarity’s differentiation
Dr Taylor said currently approved PSMA PET products miss metastatic disease in many patients, particularly those with small volume disease. Per the FDA-approved labels he cited, PET positivity rates in BCR are 36% for 68Ga-PSMA-11 and 35% for 18F-DCFPyL in patients with PSA below 0.5 ng/mL. They rise to 56% and 50% respectively at PSA 0.5 to below 1.0 ng/mL.
Clarity’s proprietary sarcophagine (SAR) Technology uses a cage-like chelator to hold copper isotopes securely. Copper-64 has a half-life of 12.7 hours, compared with 1-2 hours for gallium-68 and fluorine-18, which enables imaging timepoints of up to 30 hours post-injection.
Clarity filed a patent for the composition of matter in June 2018, providing protection until at least 2038. Dr Taylor also said the longer product shelf-life supports centralised and regional manufacture and broad geographic distribution.
Supply readiness is being built in parallel, with a third US copper-64 plant in Atlanta adding 14 cyclotrons to a manufacturing network that already includes SpectronRx and Nusano.
On the market, Dr Taylor said PSMA PET sales are around US$2 billion per year in the US alone, and are expected to grow to over US$3 billion by 2029.
What happens next for Clarity
Clarity is progressing two registrational Phase III trials, both now in patient follow-up. As pivotal trials, their final results are intended to support an application to the US FDA for approval of Cu-64 SAR-bisPSMA as a new diagnostic imaging agent.
- AMPLIFY (NCT06970847), in BCR: the target number of participants was achieved in March 2026, and participants are expected to complete follow-up in the coming weeks. Topline data are anticipated in the first half of CY2027.
- CLARIFY (NCT06056830), in patients prior to radical prostatectomy: the target number of participants was achieved in October 2026, and participants are expected to complete follow-up in the coming weeks. Topline data are anticipated in the first half of CY2027.
Cu-64 SAR-bisPSMA is an unregistered product, and there is no guarantee it will become commercially available.
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