Health Check: Clarity shares soar on ‘breakthrough’ FDA designation

Detailed summary

Clarity Pharmaceuticals shares today surged 40% after the FDA granted 'breakthrough designation" for the company's prostate imaging tool. ... Read More The post Health Check:…

The FDA's 'breakthrough' designation for Clarity's proposed prostate cancer imaging agent offers hope to thousands of blokes with a recurrent form of the disease. Pic: Getty Images.

Shares in radiopharma developer Clarity Pharmaceuticals (ASX:CU6) today soared more than 30% after the US Food & Drug Administration (FDA) granted ‘breakthrough’ designation to its proposed prostate cancer imaging agent.

Based on copper isotopes, Cu-64 SAR-bisPSMA (as in prostate-specific membrane antigen) images biochemical recurrence of prostate cancer using positron emission tomography (PET).

This applies to suspected recurrences based on elevated serum prostate- specific antigen (PSA) levels.

Breakthrough therapy designation expedites the development and review of drugs intended to treat a serious condition.

This is in cases where there’s preliminary clinical evidence a drug or device might be a substantial improvement on available therapies.

Breakthrough therapy can also lead to a therapy being granted priority review status.

The FDA was convinced by Clarity’s phase II and separate phase I/II trials known as Cobra, as well as ‘real world’ evidence.

Clarity has two registrational phase III trials underway, both of which have successfully recruited and are in patient follow-up.

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