Welcome to our dedicated page for Cingulate news (Ticker: CING), a resource for investors and traders seeking the latest updates and insights on Cingulate stock.
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company headquartered in Kansas City, Kansas. The company is dedicated to transforming patient care through its proprietary Precision Timed Release™ (PTR™) drug delivery platform, which enables the development of next-generation pharmaceutical products designed to address significant unmet medical needs. Cingulate focuses on creating innovative solutions for conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes, with an initial emphasis on Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders.
Core Technology: Precision Timed Release™ (PTR™) Platform
Cingulate's PTR™ platform is a groundbreaking drug delivery technology that provides precise, pre-defined, multi-release dosing within a single tablet. This technology incorporates a proprietary Erosion Barrier Layer (EBL), which controls drug release at specific time intervals, ensuring that active pharmaceutical ingredients are delivered at optimal times throughout the day. Unlike conventional extended-release formulations, the PTR™ platform is designed to offer entire active-day efficacy, eliminating the need for additional doses or "booster" medications. The technology has been licensed from BDD Pharma and is adaptable for use in various therapeutic areas beyond ADHD and anxiety disorders.
Pipeline and Product Candidates
Cingulate's lead candidate, CTx-1301 (dexmethylphenidate), is being developed for the treatment of ADHD. Utilizing the PTR™ platform, CTx-1301 aims to provide rapid onset, entire active-day duration, and improved patient compliance. The company has completed multiple Phase 3 studies, including adult and pediatric trials, and is on track to submit a New Drug Application (NDA) to the FDA by mid-2025. Additionally, Cingulate is advancing CTx-2103 (buspirone) for the treatment of anxiety disorders, leveraging FDA's 505(b)(2) regulatory pathway to expedite development.
Market Opportunity
The global ADHD market represents a significant growth opportunity, with millions of children and adults requiring effective treatment options. Current ADHD therapies often fall short in providing consistent, all-day symptom control, leading to high demand for innovative solutions like CTx-1301. Similarly, anxiety disorders remain an underserved market, with substantial potential for improvement in treatment outcomes. Cingulate's ability to address these gaps positions it as a potential disruptor in the biopharmaceutical space.
Strategic Initiatives and Competitive Positioning
Cingulate has secured patents in multiple territories, including Europe, Australia, Canada, and Israel, with additional patents pending in the United States, Hong Kong, and South Korea. These intellectual property protections strengthen the company's competitive position and support its global expansion strategy. The company is actively engaging in licensing discussions with pharmaceutical partners in the U.S. and abroad, aiming to commercialize its products and generate non-dilutive capital. Furthermore, Cingulate's focus on regulatory compliance, such as completing FDA-required studies and manufacturing registration batches, underscores its commitment to achieving timely approvals and market entry.
Financial Sustainability and Growth
Despite operating in a capital-intensive industry, Cingulate has demonstrated financial resilience by raising significant capital through equity offerings, warrant inducements, and strategic partnerships. These efforts have extended the company's cash runway, enabling it to fund ongoing clinical, manufacturing, and regulatory activities. By prioritizing cost containment measures and exploring non-dilutive funding options, Cingulate is well-positioned to execute its strategic plan and achieve long-term growth.
Future Outlook
As Cingulate prepares for the FDA submission of its lead asset, CTx-1301, the company is poised to make a meaningful impact on the ADHD treatment landscape. With its innovative PTR™ platform, robust intellectual property portfolio, and strategic focus on addressing unmet medical needs, Cingulate is building a pipeline of next-generation pharmaceutical products that have the potential to transform patient care and improve quality of life.
Cingulate, a biopharmaceutical company listed on NASDAQ under the symbol CING, will host a live event featuring CEO Shane J. Schaffer and ADHD expert Dr. Ann Childress. The event will be held on June 26, 2024, at 10:30 a.m. CST, and will be accessible via Benzinga’s YouTube channel and Cingulate’s website. During the event, the discussion will cover unmet needs in ADHD, results from Cingulate’s Phase 3 Fixed-Dose Study in pediatrics and adolescents, and potential expansion of the company's Precision Timed Release™ platform into other therapeutic areas. Dr. Schaffer will also provide a company overview.
Cingulate announced a significant achievement in the development of its ADHD drug, CTx-1301, by completing twelve required registration batches. This milestone meets the U.S. Food and Drug Administration (FDA) manufacturing requirements necessary for New Drug Application (NDA) submission. The company is using its Precision Timed Release™ (PTR™) technology to develop CTx-1301, intended to offer a reliable manufacturing process and acceptable shelf life. Cingulate plans to submit the NDA for CTx-1301 in the first half of 2025, marking a important step towards FDA marketing clearance.
Cingulate has received FDA confirmation on the requirements for filing a New Drug Application (NDA) for its Phase 3 candidate, CTx-1301, aimed at treating ADHD in patients aged six and older. The FDA has agreed that data from ongoing Phase 3 studies are sufficient for submission under the 505(b)(2) pathway, eliminating the need for further fixed dose and onset/duration studies. Cingulate will also conduct a brief Phase 1 fed/fast study to include in the NDA. The company aims to submit the NDA in the first half of 2025. Cingulate is also negotiating with potential commercialization partners and payers to maximize market access for CTx-1301, which may benefit over 60% of ADHD patients currently using booster doses. The drug has shown promising results, with patients expressing a desire to continue its use post-trial.
Cingulate Inc. reported its first quarter 2024 financial results, showing positive trends with $10 million increase in stockholders' equity and capital raising efforts totaling $10.7 million. The company is on track to file for Marketing Approval with the FDA for CTx-1301 in the first half of 2025. R&D expenses decreased, and total stockholders' equity saw a $10 million increase from the end of 2023.
Cingulate Inc. announced that Peter J. Werth, a successful pharma entrepreneur and investor, will be featured with Chairman and CEO Shane J. Schaffer on a live Benzinga event. Werth will discuss his background and vision for Cingulate, while Schaffer will provide company updates. The event will take place on May 3, 2024, at 12:10 p.m. EST.
FAQ
What is the current stock price of Cingulate (CING)?
What is the market cap of Cingulate (CING)?
What is Cingulate Inc.'s core focus?
What is the Precision Timed Release™ (PTR™) platform?
What is Cingulate's lead product candidate?
How does Cingulate generate revenue?
What are the company's key competitive advantages?
What is the timeline for the FDA approval of CTx-1301?
What markets does Cingulate target?
How does Cingulate ensure financial sustainability?
