FDA slaps CRL on Cingulate’s CTx-1301 NDA

Shares of US biopharma company Cingulate (Nasdaq: CING) closed up 11.9% at $4.03 on Tuesday, after it announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for its New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) for the treatment of attention deficit/hyperactivity disorder (ADHD).

The response identified specific Chemistry, Manufacturing and Controls (CMC) information requests but, importantly, an did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301. Kansas City-based Cingulate said it expects a prompt submission to FDA of the requested information addressing issues raised.