Why Are Cingulate Shares Trading Higher Today?

Cingulate Inc CING announced topline results from its Phase 3 adult trial of its lead candidate, CTx-1301 (dexmethylphenidate) for attention-deficit/hyperactivity disorder (ADHD).

The data demonstrated a meaningful trend in improving ADHD symptoms with a rapid onset of action and entire active-day duration. 

Subjects randomized to their optimized dose of CTx-1301 showed improvements on the Permanent Product Measure of Performance (PERMP) compared to subjects randomized to a placebo.

The overall effect size showed a trend toward significance with a p-value of 0.089 despite the modest sample size. A Meta-Analysis conducted by Faraone and Glatt using 11 published studies with long-acting stimulants in adults demonstrated the average effect size to be 0.73 (approximate range 0.5 to 0.9). 

Subjects randomized to CTx-1301 demonstrated an effect size of 1.41 at 30 minutes and an effect size of 0.98 at 16 hours. 

In addition, the severity of illness decreased in subjects randomized to CTx-1301 compared to placebo.

In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study this month and a dose-optimization onset and duration trial in pediatric patients in August 2023. 

Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.

Earlier this year, Cingulate announced positive topline results from the CTx-1301-003 study assessing the effect of food on the absorption of CTx-1301. 

Price Action: CING shares are up 11.30% at $1.03 on the last check Tuesday.