Clarity Pharmaceuticals Ltd (ASX: CU6) shares are roaring higher on Tuesday morning.
At the time of writing, the ASX 300 biotech share is up 9% to $5.87.
Why is this ASX 300 biotech share roaring higher?
Investors have been bidding the radiopharmaceutical company's shares higher today after responding very positively to a trial update.
According to the release, the Co-PSMA (NCT06907641) investigator-initiated trial (IIT) has achieved its primary endpoint.
It notes that there was a statistically significant higher number of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions detected using 64Cu-SAR-bisPSMA in patients with low prostate-specific antigen (PSA) levels. This is compared to the standard-of-care (SOC) 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT).
In more simplified terms, the trial has successfully met its primary endpoint, demonstrating that its product detects significantly more lesions per patient than what is currently being used by healthcare practitioners.
As a result, management believes this supports the theory that 64Cu-SAR-bisPSMA can improve early detection of recurrence and staging of prostate cancer in patients with low PSA who are candidates for curative salvage therapy.
This could be good news for both the company and patients. It highlights that the current market for PSMA PET imaging in the US is ~US$2 billion a year. This is expected to grow to over US$3 billion by 2029. However, it points out that this entire market is currently served by products that have low sensitivity.
In light of this, management believes that with the clinical and logistical benefits offered by 64Cu-SAR-bisPSMA, it could become the standard of care in PSMA PET and grow the market opportunity further by diagnosing prostate cancer earlier.
Commenting on the news, the ASX 300 biotech stock's executive chair, Dr Alan Taylor, said:
Achieving the primary endpoint in the Co-PSMA trial, which was a head-to-head trial against a SOC competing product, is yet another important step in the development of 64Cu-SAR-bisPSMA as we look to further validate this agent as best-in-class through two registrational trials with two Fast Track Designations (FTDs) under our belt for diagnostic applications and a strong focus on commercialisation.
The current market for PSMA PET imaging in the US alone is around US$2 billion per year, and this is expected to further grow to over US$3 billion by 2029. However, this entire market is currently served by products that have low sensitivity, while the development pipeline of new products, excluding 64Cu-SAR-bisPSMA, offers no differentiation from the existing agents, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. We believe that with the clinical and logistical benefits offered by 64Cu-SAR-bisPSMA we could not only become the new SOC in PSMA PET but grow the market opportunity further by diagnosing prostate cancer earlier, while lesions are still very small.
