Cingulate(US:CING) Globenewswire·2025-09-17 12:45Core Insights - Cingulate Inc. has entered into a strategic commercial supply agreement with Bend Bio Sciences for the manufacturing of its lead asset CTx-1301, pending FDA approval [1][3] - CTx-1301 is a novel, extended-release formulation of dexmethylphenidate aimed at addressing limitations of current ADHD therapies, with an NDA submitted to the FDA on July 31, 2025 [2][3] - The agreement ensures Bend Bio Sciences will be the exclusive manufacturer of CTx-1301 in the U.S. through 2028, contingent on FDA approval, providing manufacturing security and operational efficiency for Cingulate [3][4] 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][9] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9] Product Details - CTx-1301 utilizes Cingulate's PTR technology to deliver dexmethylphenidate in a multi-core formulation designed for precise release at defined intervals, addressing the challenge of providing an entire active-day duration of action [6][7] - The formulation is designed to enhance patient care by delivering medication in a single tablet, improving adherence and treatment efficacy [6][8] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment options are often inadequate, highlighting the need for innovative therapies like CTx-1301 [5][6] - The prevalence of adult ADHD is growing faster than that of children and adolescents, indicating a substantial market opportunity for effective treatment solutions [5]