Cingulate Receives FDA Complete Response Letter for CTx-1301

Cingulate Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) for the treatment of ADHD. The FDA's feedback primarily focused on Chemistry, Manufacturing and Controls (CMC) information requests, with no current concerns identified regarding the clinical safety or efficacy of CTx-1301. Cingulate plans a prompt resubmission of the requested information and stated it is well-capitalized with nearly $30 million in cash, which is expected to fund operations and pre-commercial activities into 2027.