Welcome to our dedicated page for Cingulate news (Ticker: CINGW), 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, dedicated to revolutionizing the pharmaceutical landscape with its proprietary Precision Timed Release™ (PTR™) drug delivery platform. With a mission to address unmet medical needs, Cingulate focuses on developing next-generation pharmaceutical products designed to improve the lives of patients suffering from conditions characterized by suboptimal treatment outcomes and challenging daily dosing regimens. The company's innovative approach aims to provide precise, controlled drug delivery, ensuring efficacy and convenience in a single daily dose.
Core Technology: Precision Timed Release™ (PTR™) Platform
At the heart of Cingulate's operations is its PTR™ drug delivery platform, a cutting-edge technology that enables the precise, pre-defined release of active pharmaceutical ingredients at specific intervals throughout the day. The platform incorporates a proprietary Erosion Barrier Layer (EBL), which controls drug release without premature activation. This tablet-in-tablet design ensures optimized therapeutic outcomes by delivering medication at the right time, dosage, and release style. Licensed from BDD Pharma, the PTR platform is adaptable across multiple therapeutic areas, making it a versatile tool for addressing complex medical needs.
Product Pipeline and Therapeutic Focus
Cingulate's initial focus is on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), a condition affecting millions of children and adults globally. Its lead candidate, CTx-1301 (dexmethylphenidate), is a stimulant medication designed to provide rapid onset and full active-day efficacy in a single dose. By eliminating the need for booster doses, CTx-1301 addresses a significant gap in ADHD treatment. The company is also advancing CTx-2103 (buspirone) for the treatment of anxiety disorders, leveraging its PTR platform to optimize drug delivery in this therapeutic area. Beyond ADHD and anxiety, Cingulate is exploring additional indications where its technology could offer substantial improvements over existing therapies.
Market Position and Competitive Advantage
Cingulate operates in the highly competitive biopharmaceutical industry, particularly within the ADHD and anxiety treatment segments. The company's focus on once-daily dosing and its innovative PTR technology differentiate it from traditional extended-release formulations. By addressing common challenges such as suboptimal treatment adherence and fluctuating drug efficacy, Cingulate positions itself as a pioneer in precision drug delivery. The granting of patents in Europe, Australia, Canada, and Israel further underscores its commitment to global expansion and intellectual property protection.
Regulatory and Clinical Progress
Cingulate has made significant strides in advancing its clinical pipeline. The company recently completed its final FDA-required study for CTx-1301, targeting a mid-2025 submission for a New Drug Application (NDA). This milestone reflects Cingulate's adherence to rigorous regulatory standards and its readiness to bring innovative treatments to market. Additionally, its engagement with key stakeholders, including potential licensing partners and payers, highlights a strategic approach to commercialization and market access.
Future Outlook
With a robust pipeline, global patent portfolio, and innovative technology platform, Cingulate is well-positioned to address unmet medical needs in ADHD, anxiety, and beyond. The company's focus on precision drug delivery and patient-centric solutions aligns with evolving healthcare demands, offering significant potential for growth and impact in the pharmaceutical industry.
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.
Cingulate Inc. (NASDAQ: CING) reported its Q3 2022 financial results, highlighting key advancements in its drug development pipeline. The company initiated a food effect study of its ADHD candidate, CTx-1301, and plans to start a Phase 3 adult dose-optimization study in December 2022. Cingulate executed a Master Services Agreement with Societal CDMO for manufacturing support. The firm has $9.8 million in cash as of September 30, 2022, down from $16.5 million at year-end 2021, and expects to fund operations through Q1 2023. Q3 net loss narrowed to $4 million from $15.3 million in 2021.
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