Cingulate (CING) announced that the U.S. Food and Drug Administration, FDA, has accepted for review the New Drug Application, NDA, for CTx-1301, the company’s lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder, ADHD, in children and adults. The FDA has assigned a Prescription Drug User Fee Act, PDUFA, target action date of May 31, 2026. NDA acceptance signifies that the Agency has determined the submission is sufficiently complete to permit substantive review.
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