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 Inc. (NASDAQ: CING) announced that its Chairman and CEO, Shane J. Schaffer, will speak at a live Benzinga All Access event on April 18, 2023, at 10 a.m. CST. The discussion will focus on unmet needs in attention deficit/hyperactivity disorder (ADHD) and the expansion of Cingulate's Precision Timed Release™ (PTR™) platform into anxiety treatments. Schaffer will provide a company overview and recap recent clinical and business updates. The event will be available for viewing on Benzinga's YouTube channel and on Cingulate's website.
Cingulate is a biopharmaceutical company focused on developing next-generation pharmaceutical products aimed at improving treatment outcomes for patients with ADHD and potentially anxiety disorders through its PTR platform.
Cingulate Inc. (NASDAQ: CING) has completed the first cohort of its Phase 3 trial for CTx-1301, a treatment for adult ADHD, with results expected in 3Q 2023. This trial assesses the onset and duration of CTx-1301 in adults aged 18-55. Following this, Cingulate plans a pivotal Phase 3 fixed-dose trial for pediatric and adolescent patients slated to begin mid-2023. If successful, a New Drug Application (NDA) could be submitted in early 2024. CTx-1301 aims to provide entire active-day efficacy with once-daily dosing, enhancing the ADHD treatment landscape as no current stimulant medication offers this benefit.
Cingulate Inc. has announced a commercial agreement with Indegene to support the launch of its ADHD treatment, CTx-1301. This novel medication aims to provide a true, once-daily dose with efficacy lasting up to 16 hours, targeting a significant unmet need in the $20 billion ADHD market. The agreement includes comprehensive commercialization strategies designed to drive revenue and support Cingulate during its Phase 3 clinical trials, with results anticipated in Q3 2023. This partnership is expected to enhance Cingulate's operational efficiency and mitigate resource risks, positioning the company for a successful FDA approval and market entry.
Cingulate Inc. (NASDAQ: CING) announced financial results for the year ending December 31, 2022, highlighting progress in its clinical development. Major updates include the ongoing Phase 3 Adult Dose-Optimization Study for CTx-1301, expected to yield results in Q3 2023, and plans to initiate a pediatric study in mid-2023. The company had $5.4 million in cash at year-end, down from $16.5 million the previous year, which could fund operations into Q2 2023. Cingulate reported a net loss of $17.7 million for 2022, an improvement from $20.7 million in 2021, driven by lower one-time charges and increased development activity.
Cingulate Inc. (NASDAQ: CING) announced positive results from its CTx-1301-003 trial, demonstrating that its ADHD treatment, CTx-1301, can be taken with or without food. This investigational drug utilizes the Precision Timed Release™ platform for effective drug delivery. The trial involved 23 adults and measured pharmacokinetic parameters, confirming the drug's favorable tolerability profile. The company plans to initiate its pivotal Phase 3 trials in mid-2023, focusing on pediatric and adult populations. The results underscore the potential of CTx-1301 to meet critical needs in ADHD treatment, promising a single daily dose with enhanced efficacy.
Cingulate Inc. (NASDAQ: CING) announced the initiation of its first Phase 3 clinical trial for CTx-1301, a novel, extended-release tablet for treating ADHD, expected to yield initial results in the first half of 2023. The trial aims to evaluate both efficacy and safety compared to a placebo, targeting adults aged 18 to 55. CTx-1301 seeks to provide a single dose with effects lasting up to 16 hours, eliminating the need for booster doses that many patients currently require. The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2024.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will participate in a Benzinga All Access event on December 16, 2022, at 9:20 a.m. CST, discussing unmet needs in ADHD and expansion into anxiety treatments. This event was initially scheduled for December 2, 2022. The session will highlight Cingulate’s proprietary Precision Timed Release™ (PTR™) drug delivery platform. Viewers can access the event live on Benzinga’s YouTube channel or Cingulate’s website.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will participate in a Benzinga All Access event on December 2, 2022, at 10 a.m. CST. The discussion will focus on unmet needs in Attention Deficit/Hyperactivity Disorder (ADHD) and the expansion of Cingulate's Precision Timed Release™ (PTR™) platform into anxiety therapeutics. The event will be live-streamed on Benzinga’s YouTube channel and Cingulate’s website. Cingulate's mission is to develop next-generation treatments that improve patient outcomes in ADHD and potentially anxiety disorders.
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