Concert Pharmaceuticals today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that its CTP-543 Phase 2a clinical trial for alopecia areata has been placed on clinical hold. …prior to dosing subjects, the FDA informed the Company that a review of certain recently completed non-clinical toxicology studies is required before proceeding. The FDA did not cite a safety concern; however, they intend to review these additional non-clinical data as support for the one-year dosing duration as planned in the Phase 2a trial.
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