Key highlights

  • Clarity Pharmaceuticals shares closed at $2.05 on 12 November 2026, up 23.49%, while the S&P/ASX 200 eased 0.07%.
  • The company announced on 12 November 2026 that the FDA granted Breakthrough Therapy Designation to Cu-64 SAR-bisPSMA for PSMA PET imaging in suspected prostate cancer recurrence.
  • Two Phase III trials, AMPLIFY and CLARIFY, have completed recruitment, with topline data expected in the first half of calendar 2027.

Shares in Clarity Pharmaceuticals Ltd (ASX:CU6) closed at $2.05 on Thursday 12 November 2026, up 23.49% on the session. The S&P/ASX 200 closed at 9,146.80, down 0.07%. Clarity is a clinical-stage radiopharmaceutical company developing Targeted Copper Theranostics using its proprietary SAR technology. Its latest update was an announcement dated 12 November 2026 on FDA Breakthrough Therapy designation, released on the same day as the share close.

FDA Breakthrough Therapy designation

The company said the United States Food and Drug Administration granted Breakthrough Therapy designation to 64Cu-SAR-bisPSMA for positron emission tomography of PSMA-positive lesions in men with prostate cancer and suspected recurrence based on elevated PSA. Clarity described it as the first Breakthrough Therapy designation in the history of PSMA PET imaging. The designation brings Fast Track features, intensive FDA guidance on the development program and senior-level FDA involvement in review. The company noted that fewer than half of designation requests across all therapeutic areas are successful.

Supporting clinical data

The designation was supported by the Phase II Co-PSMA investigator-initiated trial and the Phase I/IIa COBRA study. In Co-PSMA, which enrolled 50 participants with a median PSA of 0.43 ng/mL, 64Cu-SAR-bisPSMA detected lesions in 78% of patients on next-day imaging, compared with 36% for 68Ga-PSMA-11. The study was published as an Editor's Choice article in European Urology. In COBRA, detection rates on next-day imaging ranged from 58% to 80% across readers, and the company reported that investigators planned treatment changes for 44% of patients.

Pivotal trial progress

Clarity is running two registrational Phase III trials. AMPLIFY, which studies recurrence after initial treatment, reached its target enrolment in March 2026. CLARIFY, which studies men with high-risk prostate cancer before radical prostatectomy, reached its target in October 2026. Both have completed recruitment and are in patient follow-up, with topline data expected in the first half of calendar 2027. The company says the final results are intended to support an application to the FDA for approval as a diagnostic imaging agent.

Market context

Clarity cited a PSMA PET market in the United States of around US$2 billion a year, which it expects to exceed US$3 billion by 2029. The company said its ambition extends beyond market size and centres on improving patient outcomes.

Sector context

PSMA PET imaging has become a major part of prostate cancer diagnosis, and radiopharmaceutical developers are competing to improve detection in patients with low PSA levels. Clarity's Cu-64 approach relies on a longer half-life than the gallium-68 and fluorine-18 agents already approved, which the company says allows imaging up to 30 hours after injection. The broader ASX 200 was little changed on 12 November.

Risks and limitations

Clarity's products are unregistered. Neither 64Cu-SAR-bisPSMA nor 67Cu-SAR-bisPSMA has been assessed for safety and efficacy by the FDA or the Therapeutic Goods Administration, and there is no guarantee they will become commercially available. Breakthrough designation speeds up development but does not guarantee approval. Pivotal topline data are not yet available, and the supporting evidence includes investigator-initiated and smaller studies.

What to watch ahead

The key near-term milestone is topline data from AMPLIFY and CLARIFY, expected in the first half of calendar 2027. Investors will also be looking for the timing of any New Drug Application and whether the company seeks Priority Review, which the designation may support.

Closing thoughts

Clarity shares finished the session up 23.49% at $2.05 on the day the company announced its FDA designation. The announcement highlights the company's progress in its prostate cancer imaging program, with the outcome of the two pivotal trials still to come.