Cingulate submits NDA for ADHD treatment to FDA

KANSAS CITY - Biopharmaceutical company Cingulate Inc. (NASDAQ:CING), currently valued at $28 million, announced Wednesday it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for CTx-1301, its lead candidate for treating Attention Deficit/Hyperactivity Disorder. According to InvestingPro data, while the company holds more cash than debt, it’s currently experiencing rapid cash burn.

CTx-1301 is an extended-release tablet formulation of dexmethylphenidate designed to provide fast onset and full-day efficacy with a single dose. The company may learn if the NDA has been accepted for review within 60 days of its July 31 submission.

"The submission of the NDA for CTx-1301 is the culmination of years of clinical and manufacturing development," said Matthew Brams, Cingulate’s Chief Medical Officer, in a press release statement.

The drug utilizes Cingulate’s proprietary Precision Timed Release drug delivery platform technology, which is designed to deliver three releases of medication at predefined times in a single tablet.

According to the company, over 20 million patients in the U.S. have been diagnosed with ADHD, including 12 million adults and more than 8 million under age 17. The company estimates the U.S. ADHD market at $23 billion. Analyst targets for Cingulate range from $8 to $61 per share, reflecting diverse views on the company’s potential in this market. InvestingPro subscribers can access 8 additional key insights about the company’s financial health and market position.

Cingulate’s submission represents the first regulatory application of its Precision Timed Release platform technology, which incorporates an Erosion Barrier Layer providing control of drug release at specific times.

The company is also exploring applications of its technology for anxiety disorders and other conditions requiring multiple daily doses of medication.

In other recent news, Cingulate Inc. has received a fiscal year 2025 PDUFA fee waiver from the U.S. Food and Drug Administration for its new drug application for CTx-1301, saving the company approximately $4.3 million. The company is preparing to submit this application at the end of July. Additionally, Cingulate has appointed Nilay Patel as Chief Legal Officer, bringing over 20 years of experience as they move forward with the FDA filing for their ADHD treatment candidate, CTx-1301. In another development, Cingulate announced an expansion of its equity incentive plan, adding 800,000 shares following stockholder approval. This amendment was part of several key proposals during the company’s 2025 Annual Meeting of Stockholders, where Peter J. Werth was elected as a Class I director and KPMG LLP was ratified as the independent auditor. Furthermore, Cingulate received formal pre-NDA meeting feedback from the FDA for CTx-1301, including agreement on a post-NDA approval commitment for additional stability data and reliance on the efficacy and safety data of the listed drug, Focalin XR. These developments are part of Cingulate’s ongoing efforts to bring its ADHD treatment to market.

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