Cingulate Inc.'s (CING) once-daily CTx-1301, proposed for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults, is under FDA review, with a decision due on May 31, 2026.CTx-1301 utilizes the company's innovative Precision Timed Release (PTR) drug delivery platform technology to create a breakthrough multi-core formulation of dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. The drug is being reviewed by the FDA under the 505(b)(2) regulatory pathway.Several medications are approved for the treatment of ADHD and are classified as either stimulants or non-stimulants. Research indicates that stimulant medications are the most effective and are typically used as first-line treatment for managing ADHD symptoms. However, most currently available extended-release formulations of Stimulants require multiple doses per day and often fail to provide consistent coverage across the entire active day.CTx-1301 is designed to address this gap by offering a once-daily dosing regimen intended to provide sustained symptom control throughout the day.If approved, the company estimates a market opportunity of over $1 billion for CTx-1301.CING closed Monday's trading at $5.26, down 3.84%.