Clarity’s Cu-SAR-bisPSMA doubles lesion detection in Phase II trial

Co-PSMA Trial Signals Diagnostic Leap

Clarity Pharmaceuticals (ASX:CU6) has delivered compelling evidence that its 64Cu-SAR-bisPSMA PET imaging agent could redefine prostate cancer diagnostics. The Phase II Co-PSMA investigator-initiated trial, led by Prof Louise Emmett at St Vincent’s Hospital Sydney, demonstrated that next-day imaging with 64Cu-SAR-bisPSMA identified more than twice as many cancer lesions per patient compared to the current standard-of-care 68Ga-PSMA-11 (mean 1.26 vs. 0.48 lesions, p < 0.0001). This translated into a higher proportion of patients with positive scans (78% vs. 36%) and a patient-level true positive rate of 71% versus 29% for the comparator.

Crucially, these imaging improvements led to clinically meaningful shifts in patient management, with active planned treatment rising from 66% based on 68Ga-PSMA-11 results to 90% following 64Cu-SAR-bisPSMA findings. The trial focused on patients with biochemical recurrence (BCR) and low PSA levels, a cohort where conventional PSMA PET scans often fall short. The findings were presented at the European Association of Urology Congress 2026 and published in European Urology, lending strong scientific validation to Clarity’s lead diagnostic product. These results add to a growing body of evidence, including the COBRA trial, supporting 64Cu-SAR-bisPSMA’s superior sensitivity in detecting elusive prostate cancer lesions. This breakthrough was covered in detail in the recent Cu-SAR-bisPSMA Outperforms Standard Imaging report.

Phase III Trials and Manufacturing Scale-Up

Clarity has closed recruitment in its registrational Phase III AMPLIFY trial, dosing and imaging 232 participants with biochemical recurrence of prostate cancer across the US and Australia. This trial, alongside the ongoing CLARIFY Phase III study focusing on high-risk patients prior to radical prostatectomy, forms the backbone of Clarity’s regulatory submission strategy to the US Food and Drug Administration (FDA) for 64Cu-SAR-bisPSMA market approval.

Supporting these clinical advances, Clarity has secured major manufacturing agreements to underpin commercial launch. In March 2026, the company signed a large-scale copper-64 supply deal with Theragenics, whose Atlanta facility operates 14 cyclotrons capable of producing thousands of doses daily with a 48-hour shelf-life. This agreement complements existing supply contracts with SpectronRx and Nusano, creating a robust, geographically diversified supply chain across the US. In April, Clarity also inked a Commercial Manufacturing Agreement with Nucleus RadioPharma, covering production at their Minnesota site and a planned 2028 expansion in Pennsylvania, collectively able to manufacture up to 650,000 doses annually. These developments were highlighted in our recent coverage of the Major Copper-64 Supply Deal and US Manufacturing Capacity Expansion.

Theranostic Progress in SECuRE Trial

On the therapeutic front, Clarity’s SECuRE Phase I/IIa trial of 67Cu-SAR-bisPSMA in metastatic castration-resistant prostate cancer (mCRPC) continues to show promise. The Safety Review Committee recently endorsed continuation without protocol changes after reviewing interim data from nine participants. Notably, all evaluable patients showed PSA decreases, with two-thirds achieving reductions greater than 50%. Five patients have now reached undetectable disease status by radiographic assessment following treatment cycles, a remarkable outcome for an early-stage trial. The safety profile remains favourable, with mostly mild to moderate adverse events reported.

Financial Position and Leadership Updates

Clarity’s balance sheet remains strong, closing the quarter with $197.8 million in cash, underpinning ongoing clinical development and commercial preparations. Operating cash outflows of $25.5 million reflect continued investment in trials and manufacturing readiness. The company has also bolstered its leadership team with the appointments of Chris Horvath as Chief Commercial Officer and Juliane Foley as Vice President of Regulatory Affairs, both bringing deep industry expertise. Meanwhile, Dr Colin Biggin stepped down from the Board to focus on his COO role, aligning with Clarity’s governance priorities ahead of product launch.

Clarity’s three US FDA Fast Track Designations for its SAR-bisPSMA agents, covering diagnostic imaging in initial and recurrent prostate cancer, as well as therapy in mCRPC, highlight regulatory confidence in the program’s potential to address significant unmet needs in prostate cancer management.