Cingulate, Inc. (CING)

Over the past six months, Cingulate submitted its New Drug Application (NDA) to the FDA for CTx-1301 on July 31, 2025. On August 19, 2025, the company reported its second-quarter 2025 financial results, highlighted the NDA submission, and entered into a purchase agreement with Lincoln Park Capital. In October 2025, the FDA accepted Cingulate's NDA for CTx-1301 and assigned a PDUFA target action date of May 31, 2026. On November 3, 2025, Cingulate announced the appointment of Bryan Downey as Chief Commercial Officer and completed a $6 million financing transaction. On November 13, 2025, the company released its third-quarter 2025 financial results and reiterated the FDA's acceptance of the CTx-1301 NDA and the PDUFA date. CING's share price declined by 15.37% between November 26, 2024, and November 25, 2025, and showed an 18.08% decrease over the last year. More recently, the stock experienced a 3.42% fall over the last month but a 7.31% rise in the past week (as of November 27, 2025).

Information regarding specific demand seasonality for Cingulate, Inc.'s products and services is not explicitly available. Given that the company's primary focus is on treatments for chronic conditions like ADHD and anxiety, significant seasonality in demand for these types of medications is generally not anticipated.

Cingulate, Inc. is a clinical-stage biopharmaceutical company focused on developing pharmaceutical products using its Precision Timed Release (PTR) drug delivery platform technology to improve the lives of patients with conditions requiring burdensome daily dosing regimens and that have suboptimal treatment outcomes. The company operates in the Healthcare sector, specifically in the Biotechnology: Pharmaceutical Preparations industry, with an initial focus on ADHD and anxiety disorders. Its major product candidates include CTx-1301 (dexmethylphenidate), CTx-1302 (dextroamphetamine), and CTx-2103 (buspirone).

Cingulate Inc. is headquartered in Kansas City, Kansas, United States, and primarily focuses on the United States market for its pharmaceutical product development and commercialization efforts.

Cingulate's reputation in the past year has been primarily influenced by its progress in clinical development and regulatory milestones for CTx-1301, alongside its financial activities. The acceptance of the NDA for CTx-1301 by the FDA and positive Phase 3 results have enhanced the company's scientific and product development reputation. Securing an exclusive U.S. manufacturing partner and a PDUFA fee waiver have also bolstered confidence in its commercialization prospects. However, the company's need for additional capital and a decline in cash reserves could be perceived as a risk to its financial reputation.

Cingulate has a notable ownership structure with significant insider holdings. Institutional shareholders own between 3.03% and 4.30% of the company, while insiders hold a substantial portion, ranging from 25.75% to 110.11%. Werth Family Investment Associates LLC is the largest individual shareholder, owning 41.41% of the company. Other major individual and insider owners include Peter J. Werth, Shane J. Schaffer, Fountainhead Shrugged LLC, Matthew Brams, Raul R. Silva, Craig S. Gilgallon, Gregg Wm Givens, and Horn Louis G. Van. Major institutional owners include Kestra Advisory Services, LLC, Vanguard Group Inc, Geode Capital Management, Llc, and others.