Clarity hits Phase III AMPLIFY enrollment goal for prostate cancer imaging agent

Clarity Pharmaceuticals Ltd. ( (AU:CU6) ) just unveiled an update.

Clarity Pharmaceuticals has reached the target number of participants in its registrational Phase III AMPLIFY trial of 64Cu-SAR-bisPSMA PET imaging for men with biochemical recurrence of prostate cancer after definitive treatment in the U.S. and Australia. Recruitment has now closed to new consents, and the trial aims to demonstrate the diagnostic performance of same-day and next-day 64Cu-SAR-bisPSMA PET/CT scans in detecting recurrent disease at low PSA levels.

Data from AMPLIFY will complement earlier COBRA and Co-PSMA studies, which showed improved lesion detection versus standard-of-care PSMA PET, and is intended to support a U.S. FDA approval application for 64Cu-SAR-bisPSMA in biochemical recurrence. The company is also running the Phase III CLARIFY trial in patients undergoing radical prostatectomy and pelvic lymph node dissection, with both studies, plus an ongoing theranostic SECuRE trial, positioning Clarity to commercialise SAR-bisPSMA across the prostate cancer continuum and potentially expand the established PSMA PET market.

The most recent analyst rating on (AU:CU6) stock is a Buy with a A$6.40 price target. To see the full list of analyst forecasts on Clarity Pharmaceuticals Ltd. stock, see the AU:CU6 Stock Forecast page.

More about Clarity Pharmaceuticals Ltd.

Clarity Pharmaceuticals Ltd. is an Australian clinical-stage radiopharmaceutical company focused on developing next-generation targeted copper theranostic agents for cancer. Its lead product, 64Cu-SAR-bisPSMA, is designed for PET imaging of prostate-specific membrane antigen in prostate cancer, with a market focus on improving diagnostic accuracy and enabling potential theranostic use across the prostate cancer care pathway.

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Technical Sentiment Signal: Buy

Current Market Cap: A$1.33B

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