Rising Shares at Clarity Pharmaceuticals as it Launches Second Phase III Trial and Promotes Michelle Parker to CEO

Biotech firm Clarity Pharmaceuticals is preparing to initiate a second Phase III clinical trial for its prostate cancer diagnostic product, 64Cu-SAR-bisPSMA, after receiving positive feedback from the US Food and Drug Administration (FDA). This announcement has boosted the company’s shares.

The new trial, named AMPLIFY, will involve approximately 220 participants and is expected to begin recruiting patients in early 2025. The trial will focus on patients experiencing biochemical recurrence of prostate cancer.

Clarity Pharmaceuticals’ shares rose nearly 4% in early ASX trading, reflecting investor optimism following the FDA’s feedback.

The company is already running another Phase III trial, called CLARIFY, which targets patients with confirmed prostate cancer. In support of these efforts, Clarity recently signed an agreement with US-based SpectronRx to streamline the manufacturing process for both the 64Cu isotope and the 64Cu-SAR-bisPSMA product.

In a separate announcement, Clarity Pharmaceuticals revealed that Michelle Parker, formerly head of clinical operations, has been promoted to CEO. Parker succeeds Colin Biggin, who served as CEO since April 2019. With six years at Clarity and a background in leading Novartis Australia’s international clinical research operations, Parker brings substantial experience to her new role.

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