FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date

Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that the U.S. Food and Drug Administrati ...