CINGULATE INC. Aktie

Cingulate published a randomized crossover study in CNS Drugs comparing CTx-1301 with a marketed dexmethylphenidate formulation in adult ADHD patients. CTx-1301 achieved comparable plasma concentrations in the early dosing interval and maintained higher concentrations later in the day. Despite a higher total dose, fewer treatment-related adverse events occurred with CTx-1301; the once-daily formulation is based on the Precision Timed Release platform and is being evaluated under the FDA 505(b)(2) pathway. » More on de.investing.com

Cingulate reports publication of the phase‑3 results for CTx‑1301 in the Journal of Child and Adolescent Psychopharmacology: all three doses tested (18.75 mg, 25 mg, 37.5 mg) showed significant improvements versus placebo at week 5 (p=0.018; 0.011; 0.001) with placebo‑adjusted effect sizes from 0.737 to 1.185 (mean effect size 0.901). The once‑daily dexmethylphenidate formulation is based on the Precision Timed Release platform and uses the Erosion Barrier Layer technology licensed from BDD Pharma; the study demonstrated a favorable safety profile. Cingulate is developing CTx‑1301 via the FDA 505(b)(2) pathway; the US ADHD market comprises about 100 million prescriptions annually and more than 20 million diagnosed patients. » More on de.investing.com

Cingulate’s stock dropped about 20% after the FDA issued a Complete Response Letter for CTx-1301. The agency requested specific information on chemistry, manufacturing and controls (CMC), but raised no concerns about clinical safety or efficacy. Cingulate says it will submit the requested documents promptly, has roughly $30 million in cash, and considers funding and plans for the pre-submission and pre-commercial activities through 2027 secured. » More on de.investing.com