Cingulate Retail Buzz Rises After FDA Greenlights Summer NDA Filing For ADHD Drug

CTx-1301 employs its Precision Timed Release system to administer three doses of dexmethylphenidate throughout the day for managing ADHD symptoms.

Cingulate Inc.'s shares generated heightened retail chatter on Wednesday after receiving the FDA's pre-New Drug Application (NDA) meeting minutes for its primary asset CTx-1301 that targets ADHD with a daily stimulant treatment.

Cingulate shares rose 8.7% to close at $4.25 on Tuesday but slipped 4.2% to $4.07 in after-hours trading.

Following a pre-NDA meeting on April 2, the company confirmed that it will submit an NDA for CTx-1301 in the summer of 2025 based on the FDA’s feedback. 

The formulation CTx-1301 contains dexmethylphenidate and employs Cingulate’s Precision Timed Release technology to provide three doses during specific times of the day. 

The technology aims to overcome the problem of reduced effectiveness in existing stimulant treatments during the afternoon hours.

The FDA minutes confirmed that the existing nonclinical safety data sufficiently support the NDA submission.

The agency entered into a post-approval agreement with Cingulate to gather stability data for six intermediate dose strengths, spanning from 12.5 mg to 43.75 mg.

The regulatory body recognized a scientific connection to Focalin XR, which permitted Cingulate to benefit from existing data on drug effectiveness and safety. 

The agency found the company’s integrated safety and efficacy summary approaches reasonable.

One user said the stock could reach $6, citing a sharp spike to $5.16 as a signal of potential upward momentum. 

On Stocktwits, retail sentiment was ‘bullish’ amid a 1,600% surge in 24-hour message volume.

Another user highlighted the absence of negative news and reaffirmed confidence in the NDA timeline, noting the company remains on track for a summer submission.

The stock has declined 16.7% so far in 2025.

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