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FDA Drops Cardiac QT Study for SCENESSE, Citing Strong Safety Data
9:04am on Monday 27th of April, 2026 AEST
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Healthcare
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FDA Drops Cardiac QT Study for SCENESSE, Citing Strong Safety Data
9:04am on Monday 27th of April, 2026 AEST
Key Points
FDA waives QT study post-approval for SCENESSE®
Longitudinal safety data underpin regulatory confidence
SCENESSE® remains sole FDA-approved EPP therapy
Company maintains steady dialogue with FDA since 2019
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Clinuvel Pharmaceuticals (ASX:CUV)
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