Cingulate receives FDA fee waiver for ADHD drug application

KANSAS CITY - Cingulate Inc. (NASDAQ:CING), a small-cap biotech company with a market capitalization of $22.16 million, 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, the company announced Tuesday.

The waiver, granted through the small business provision of the Federal Food, Drug, and Cosmetic Act, will save the biopharmaceutical company approximately $4.3 million as it prepares to submit its NDA at the end of July. According to InvestingPro data, the company maintains a favorable cash-to-debt position, though it faces challenges with cash burn rates.

CTx-1301 is a dexmethylphenidate HCI formulation developed for the treatment of Attention Deficit Hyperactivity Disorder. The drug utilizes Cingulate’s proprietary Precision Timed Release drug delivery platform, designed to deliver three medication releases at predefined times in a single tablet.

"This waiver will save Cingulate more than $4 million and strengthen our financial position as we prepare to commercialize CTx-1301," said Shane J. Schaffer, Chairman and CEO of Cingulate. The company’s stock has shown resilience, posting a year-to-date return of 5.88%, with investors anticipating the upcoming earnings report scheduled for August 11.

According to the company, CTx-1301 aims to provide rapid onset and full-day efficacy, with the third dose releasing when other extended-release stimulant products typically begin to wear off.

The company stated that over 20 million patients in the U.S. have been diagnosed with ADHD, including 12 million adults and over 8 million under the age of 17. InvestingPro subscribers can access additional insights and financial metrics to evaluate Cingulate’s market position and growth potential in this expanding therapeutic area.

The information in this article is based on a company press release statement.

In other recent news, Cingulate Inc. has received formal feedback from the FDA regarding its ADHD treatment candidate, CTx-1301. The company plans to submit a New Drug Application (NDA) for this drug during the upcoming summer. The FDA’s feedback includes agreement on a post-NDA approval commitment for additional stability data and indicates that CTx-1301 may rely on existing efficacy and safety data from Focalin XR. Additionally, Cingulate has appointed Nilay Patel as Chief Legal Officer as it prepares for the FDA filing. Patel brings over 20 years of legal experience in the pharmaceutical industry. In another development, Cingulate has expanded its equity incentive plan following stockholder approval. The plan now includes an additional 800,000 shares, bringing the total authorized shares to 1,141,826. Stockholders also elected Peter J. Werth as a Class I director and ratified KPMG LLP as the company’s independent auditor for 2025.

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