Cingulate Inc. has appointed Bryan Downey as Chief Commercial Officer and completed a financing transaction of $6 million. The FDA accepted the NDA for CTx-1301, with a PDUFA date set for May 31, 2026. Positive Phase 3 results were presented at the AACAP Annual Conference, demonstrating efficacy in ADHD treatment. Additionally, a commercial supply agreement was reached with Bend Bio Sciences for the manufacturing of CTx-1301, and a $4.3 million PDUFA fee waiver was granted by the FDA.

In the third quarter, Cingulate reported $6.1 million in cash and cash equivalents, with R&D expenses increasing to $2.8 million and G&A expenses totaling $3.1 million. The net loss for the quarter was $7.3 million. The company is focused on advancing towards a potential 2026 launch for CTx-1301 and creating value for shareholders.

CTx-1301 is a once-daily tablet utilizing Cingulate’s Precision Timed Release platform for ADHD treatment. Cingulate is also developing product candidates for anxiety disorders using this platform technology. The company aims to improve patient outcomes by reducing dosing regimens. Cingulate is headquartered in Kansas City and is listed on NASDAQ under the symbol CING.

Forward-looking statements in the press release outline the company’s plans for future milestones, including regulatory timelines, commercialization efforts, and manufacturing arrangements. Investors and media can contact Thomas Dalton, Vice President of Corporate Communications, at [email protected] or (913) 942-2301 for more information.

Read more at GlobeNewswire: Cingulate Inc. Reports Third Quarter 2025 Financial Results