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KANSAS CITY, Kan. - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company with a market capitalization of $14.7 million, has announced the receipt of formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) for its lead ADHD treatment candidate, CTx-1301. The company plans to submit an NDA for the drug during the upcoming summer. According to InvestingPro data, while Cingulate maintains a healthy current ratio of 1.87, the company is rapidly burning through its cash reserves, a common characteristic of pre-revenue biotech firms.
CTx-1301, which utilizes Cingulate’s proprietary Precision Timed Release™ (PTR™) technology, is designed to provide once-daily dosing for patients with Attention Deficit/Hyperactivity Disorder (ADHD). The feedback from the FDA includes agreement on a post-NDA approval commitment for additional stability data for six intermediate dose strengths and an adequate nonclinical safety data to support a filing. The agency also indicated that CTx-1301 may rely on the efficacy and safety data of the listed drug, Focalin XR, with a scientific bridge established upon review.
Cingulate’s Chairman and CEO Shane J. Schaffer expressed satisfaction with the FDA’s alignment with the company’s plans and thanked the agency for its guidance over the past seven years. He emphasized the potential of CTx-1301 to be the first once-daily stimulant medication to treat ADHD for the entire active day. The company’s stock, currently trading near $3.91, has seen significant volatility, with analyst price targets ranging from $8 to $62. Get deeper insights into Cingulate’s financial health and growth potential with InvestingPro, which offers exclusive analysis and 8 additional key ProTips.
ADHD is a chronic condition that affects millions in the U.S., with a significant percentage of children and adults not actively treating their symptoms with medication. The current market trends show a growing prevalence of ADHD among adults at a faster rate than the child and adolescent segments.
CTx-1301 aims to address the challenge of providing an entire active-day duration of action for stimulant medications used in ADHD treatment. Cingulate’s PTR technology, which includes a proprietary Erosion Barrier Layer (EBL), allows for precise, predefined timing of drug release.
The information provided is based on a press release statement from Cingulate Inc. The company is also exploring the use of its PTR technology for other therapeutic areas, including anxiety disorders. Further details on the drug’s approval process and its potential impact on ADHD treatment will be subject to the FDA’s review and approval timeline. With an EBITDA of -$15.75 million in the last twelve months and analysts not anticipating profitability this year, investors should closely monitor the company’s progress toward commercialization. Discover comprehensive financial analysis and real-time updates with InvestingPro.
In other recent news, Cingulate Inc. has reported promising Phase 3 safety data for its leading ADHD treatment candidate, CTx-1301. The data, submitted to the FDA, includes results from studies involving pediatric, adolescent, and adult participants, showing no serious adverse events. Cingulate’s Chairman and CEO, Shane J. Schaffer, expressed satisfaction with the drug’s consistent safety profile across nine clinical trials. The company plans to submit a new drug application for CTx-1301 in mid-2025, following a productive meeting with the FDA. The drug aims to address challenges in current ADHD treatments by offering a once-daily medication that uses Cingulate’s Precision Timed Release™ technology. This technology is designed to provide three releases of medication throughout the day, potentially eliminating the need for booster doses. Dr. Ann C. Childress, an ADHD expert, emphasized the drug’s potential to meet unmet needs in ADHD treatment. Cingulate is also exploring additional applications for its drug delivery platform in other therapeutic areas.
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