Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301

Core Insights - Cingulate Inc. has received a PDUFA fee waiver from the FDA for its new drug application for CTx-1301, which is aimed at treating ADHD, saving the company approximately $4.3 million [1][2][3] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][6] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens [6][7] Product Information - CTx-1301 is Cingulate's lead candidate, utilizing the PTR platform to deliver dexmethylphenidate in a multi-core formulation designed for optimal patient care [4] - The drug aims to provide a full-day efficacy by releasing medication at three precise intervals, addressing the challenge of maintaining effective treatment throughout the day [4] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment trends indicate a growing prevalence of adult ADHD [3] - In 2022, only 53.6% of children and teens diagnosed with ADHD were actively treating their symptoms with medication, highlighting a potential market opportunity for effective treatments [3]