Core Insights - Cingulate Inc. is making significant progress towards the commercial launch of its lead ADHD asset, CTx-1301, with a focus on its Precision Timed Release (PTR) platform designed for once-daily dosing [1][5]. Financial Performance - Cingulate reported $8.9 million in cash and $3.5 million in working capital at the end of 2Q25, which is expected to fund operations into late 2025 [5]. Product Development - The company submitted its New Drug Application (NDA) for CTx-1301 on July 31, 2025, with FDA acceptance anticipated in 4Q25 and a potential PDUFA date in mid-2026 [5]. - Positive results from the Phase 3 pediatric trial and fed/fast study have reinforced CTx-1301's efficacy and flexible dosing capabilities [5]. Commercialization Strategy - Cingulate is actively planning for commercialization in collaboration with Indegene, aiming for a product launch in mid-2026 [5]. - The company is also exploring strategic partnerships to expand its global presence [1].

Core Insights - Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's progress towards the commercial launch of its lead ADHD asset, CTx-1301 [1] - CTx-1301 is designed to provide once-daily stimulant therapy with rapid onset and sustained efficacy, addressing limitations of existing ADHD treatments [1] - Cingulate is preparing for commercialization in the U.S. and exploring out-licensing opportunities internationally, targeting a $22 billion U.S. ADHD market [1] Company Developments - Cingulate is on track to submit the New Drug Application (NDA) for CTx-1301 in mid-2025, which will include data from nine clinical trials [5] - Pediatric and high-dose studies have demonstrated strong efficacy, safety, and flexible dosing for CTx-1301 [5] - The company is actively preparing for a U.S. launch and is initiating scale-up plans pending FDA approval [5]