Cingulate, Inc. (CING)

Over the past six months, Cingulate submitted its NDA for CTx-1301 to the FDA in August 2025. In September 2025, it secured an exclusive commercial supply agreement with Bend Bio Sciences for CTx-1301 manufacturing through 2028, pending FDA approval. The FDA accepted the NDA for CTx-1301 in October 2025, setting a PDUFA target action date of May 31, 2026. Cingulate reported its Q3 2025 earnings in November 2025, missing analysts' consensus estimates, secured a $6 million financing transaction, and appointed Bryan Downey as Chief Commercial Officer. Shane Schaffer was reinstated as Chief Executive Officer in December 2025. In January 2026, Cingulate increased its at-the-market offering limit to $31.9 million and filed a $200 million mixed shelf.

As a clinical-stage biopharmaceutical company, Cingulate Inc. currently has no commercialized products generating revenue, therefore, demand seasonality is not presently applicable to its financial performance. The company's focus is on the development and regulatory approval of its drug pipeline, with a projected product launch for CTx-1301 in mid-2026, assuming FDA approval. The market for ADHD medications, which Cingulate aims to enter, is a growing market.

Cingulate, Inc. is a clinical-stage biopharmaceutical company utilizing its Precision Timed Release (PTR) drug delivery platform to develop next-generation pharmaceutical products, primarily focusing on ADHD and anxiety disorders. The company operates within the Healthcare sector, specifically in the Biotechnology and Pharmaceuticals industry, and is currently advancing its pipeline through regulatory milestones in preparation for commercial launch. Cingulate's pipeline includes CTx-1301 for ADHD, which has completed Phase 3 clinical trials with an NDA accepted by the FDA with a target action date of May 31, 2026; CTx-1302, a second-line ADHD stimulant in development; and CTx-2103, a non-stimulant anxiolytic in the formulation stage for anxiety disorders.

Cingulate Inc. is headquartered in Kansas City, Kansas, United States. While its primary market focus is the U.S., the company holds patents for CTx-1301 in up to 30 European territories, indicating potential future global market opportunities.

Cingulate's brand reputation over the past year is generally positive within the analyst community, with a consensus rating of "Moderate Buy" and a 12-month price target suggesting significant potential upside based on the anticipated approval of CTx-1301. The reinstatement of Shane Schaffer as CEO and the appointment of a Chief Commercial Officer, along with positive topline results from CTx-1301 trials, have bolstered confidence in the company.

Cingulate Inc.'s ownership is primarily composed of retail/public investors, who hold 61.60% of the shares. Insiders, including executives and directors, hold 36.19%, with Peter J. Werth holding approximately 21.00%. Institutional investors account for 2.21% of ownership, with major shareholders including Vanguard Group Inc., Kestra Advisory Services, LLC, and Geode Capital Management, Llc.