Radiopharma company $CU6 have this morning announced the latest clinical trial progresss of 64Cu‑SAR‑bisPSMA .

ASX Announcement

The Investigator-Initiatied Co‑PSMA Phase II trial provides statistically significant superiority of 64Cu‑SAR‑bisPSMA over the current Standard of Care, 68Ga‑PSMA‑11 in lesion detection at low PSA levels. This confirms the biological rationale and reinforces earlier data (PROPELLER, COBRA). While the result materially improves confidence in efficacy and diagnostic differentiation, it remains a supportive, not pivotal, dataset.

My Assessment

The NDA path still depends on Phase III outcomes (CLARIFY, AMPLIFY) and CMC readiness. These are in progress and don't report until 2026.

Overall, my "gusesstimate" of NDA probability‑of‑approval is around 66% prior to today's supportive news. While the news slightly de-risks the broader trials, it is not material enough for me to add to my position (2.7% RL). This is mainly due to the incomplete readout of this IIT. For example, it is not clear from the release what accuracy verification / reader-blind data protocols were in place - these details will be important when the FDA consider this additional information. It will be interesting to read the full account of the study when this is available.

So, good news, I expect the market will react positively, however, I'll not be taking any action today as a result.

Disc: Held in RL and SM