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KANSAS CITY - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company with a market capitalization of $15.7 million, has announced a significant step forward in the regulatory process for its leading drug candidate, CTx-1301, intended for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). According to InvestingPro data, the company currently trades near its Fair Value, maintaining a healthy current ratio of 2.55. Following a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on Wednesday, the company confirmed its plans to file a new drug application (NDA) for CTx-1301 in mid-2025. While InvestingPro analysis shows the company is quickly burning through cash, it maintains more cash than debt on its balance sheet, providing some financial flexibility for the regulatory process ahead.
The proposed ADHD medication utilizes Cingulate’s proprietary Precision Timed Release™ (PTR™) technology, which aims to deliver a once-daily stimulant medication that provides coverage throughout the active day. This technology is designed to release the medication at predefined times to optimize patient care with a single tablet.
Cingulate’s Chairman and CEO, Shane J Schaffer, expressed gratitude towards FDA personnel for their guidance, which has been instrumental in preparing the data necessary to demonstrate the drug’s consistency and therapeutic benefit. Last month, Cingulate released Phase 3 safety data for CTx-1301, which has maintained a consistent safety profile over nine clinical trials. The company plans to include a final analysis combining adult and pediatric safety and efficacy data in the NDA submission.
ADHD is a chronic condition affecting millions in the U.S., with over 20 million diagnosed patients. Current treatments face challenges in providing an entire active-day duration of action, which CTx-1301 aims to address.
CTx-1301 contains dexmethylphenidate, an FDA-approved compound for ADHD treatment, and is designed to deliver three releases of medication in one tablet using an Erosion Barrier Layer (EBL) technology. This technology controls drug release at precise times without prior release.
Cingulate’s PTR drug delivery platform is also being developed for other therapeutic areas, including anxiety disorders. The company is headquartered in Kansas City and continues to explore additional applications for its PTR technology.
The information reported is based on a press release statement from Cingulate Inc. and does not include any endorsements of claims or marketing promotions. The company’s forward-looking statements are subject to various factors that could affect future results, as detailed in filings with the Securities and Exchange Commission.
In other recent news, Cingulate Inc. has submitted Phase 3 safety data for its ADHD treatment, CTx-1301, to the FDA, with no serious adverse events reported. The company is preparing for an FDA meeting in April 2025, aiming for a new drug application submission by mid-2025. In a separate development, Cingulate announced the dismissal of charges against its CEO, Shane Schaffer, who retains full board confidence. H.C. Wainwright has raised its price target for Cingulate to $20, maintaining a Buy rating, following the completion of a key clinical program for CTx-1301. Additionally, Roth/MKM initiated coverage with a Buy rating and a $12 price target, citing potential sales of $1.6 billion by 2035 for CTx-1301. The company has also adjusted executive compensation, amending the employment agreement for its Chief Medical Officer, Matthew N. Brams. These developments reflect Cingulate’s ongoing progress in its ADHD treatment efforts and corporate governance.
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