Clarity Pharmaceuticals Ltd (ASX: CU6) shares are having a strong session on Monday.
In early trade, the ASX 300 stock jumped as much as 17% to $4.26 before pulling back.
At the time of writing, the clinical-stage radiopharmaceutical company's shares are still up around 5%.
Image source: Getty Images
Why is this ASX 300 stock jumping?
Investors appear to be responding positively to an update from the company regarding new trial data for its prostate cancer imaging technology.
The company revealed that results from the Co-PSMA study were presented at the European Association of Urology (EAU) Annual Congress 2026 in London. The data has also been accepted for publication in the European Urology journal.
The trial evaluated Clarity's diagnostic product, 64Cu-SAR-bisPSMA, in patients experiencing biochemical recurrence of prostate cancer after surgery.
Importantly, the study compared the ASX 300 stock's imaging technology with a current standard-of-care PSMA PET scan.
The results showed that Clarity's agent detected significantly more cancer lesions than the standard scan. Across the study participants, the new imaging approach identified 63 lesions compared with 24 detected using the standard-of-care method.
In addition, 78% of patients had a positive scan using 64Cu-SAR-bisPSMA compared with 36% using the existing imaging agent, highlighting a potential improvement in detecting recurrent prostate cancer.
The study also showed a higher true positive rate and lower false negative rate for the company's imaging technology.
Why this matters
Detecting prostate cancer recurrence earlier and more accurately can significantly influence treatment decisions.
According to the trial data, the improved imaging results led to changes in planned patient management in 44% of participants, with many switching from surveillance to targeted radiotherapy.
These findings add to the growing body of evidence supporting the SAR-bisPSMA platform, which is designed as a targeted copper theranostic. This technology has the potential to be used both for cancer imaging and treatment depending on the isotope used.
Looking ahead, the company intends to combine results from this study with data from other trials, including the Phase II COBRA study and the Phase III AMPLIFY trial.
Together, these results are expected to support a future regulatory submission to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA in patients with recurrent prostate cancer.
The ASX 300 stock's executive chair, Dr Alan Taylor, commented:
The extraordinary quality of the academic research is coupled with the feverish pace of commercialisation where our registrational Phase III trials, AMPLIFY and CLARIFY, are nearing completion. We have recently shared that AMPLIFY reached its target number of participants with rising or detectable PSA after initial definitive treatment at clinical sites across the US and Australia in just 9 months since imaging the first patient, and we look forward to collecting and analysing the final study data.
Combined with results from the Co-PSMA and COBRA trials, we believe it will constitute a compelling application for approval of 64Cu-SAR-bisPSMA by regulatory authorities for the BCR indication.
