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) has completed a Pre-NDA meeting with the FDA regarding its lead ADHD treatment asset CTx-1301 (dexmethylphenidate HCl). The company remains on schedule for a New Drug Application submission in mid-2025.
The company recently released Phase 3 safety data for CTx-1301 and results from a food effect study using a single 50-mg dose in healthy adults. The safety profile has remained consistent across nine clinical trials. CTx-1301 is positioned to be the first true once-daily stimulant medication for ADHD treatment throughout the active day, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform.
A final analysis combining both adult and pediatric safety and efficacy data will be included in the upcoming NDA submission.
Cingulate reported its full year 2024 and Q4 results, highlighting significant progress towards NDA submission for its ADHD treatment CTx-1301. The company secured a $17.5 million increase in working capital, extending cash runway into Q4 2025. Key developments include:
- Scheduled FDA Pre-NDA meeting for April 2, 2025
- Completed safety data from Phase 3 pediatric and adolescent studies with no serious adverse events
- Finished final FDA-required food effect study
- Secured European patent for CTx-1301
Financial highlights:
- Cash position: $12.2 million as of December 31, 2024
- Working capital: $7.5 million
- R&D expenses decreased to $9.4 million from $15.5 million in 2023
- Net loss reduced to $15.5 million from $23.5 million in 2023
Cingulate (NASDAQ: CING) has announced positive safety results from its final Phase 3 trials for CTx-1301, their lead ADHD treatment asset. The data encompasses two Phase 3 pediatric and adolescent studies (fixed dose and dose optimization) and a food effect study with healthy adults using a 50mg dose.
Key safety findings show no serious treatment emergent adverse events (TEAEs) or deaths, with no clinically relevant trends in TEAEs overall. The food effect study's medical findings align with previous 25mg dose results, indicating CTx-1301 can be taken with or without food.
The company has submitted these results to the FDA ahead of an in-person Pre-NDA meeting scheduled for April 2, 2025. Cingulate plans to file for FDA approval in mid-2025, positioning CTx-1301 as the first true once-daily stimulant medication for treating ADHD throughout the entire active day.
Cingulate Inc. (NASDAQ: CING) has completed its final FDA-required food effect study for CTx-1301, its lead ADHD treatment drug. The study evaluated a single 50mg dose of CTx-1301 (dexmethylphenidate) to determine if the medication can be taken with or without food, with no serious adverse events reported.
Data readout regarding bioavailability is expected in Q2 2025. A previous study in 2022 with a 25mg dose demonstrated that CTx-1301 could be taken regardless of food intake. The company is developing CTx-1301 to be the first true once-daily stimulant medication for ADHD treatment over an entire active day. Cingulate targets submission of the New Drug Application (NDA) to the FDA by mid 2025.
Cingulate Inc. (NASDAQ: CING) has secured a financing transaction worth $5 million in net proceeds through a non-convertible, unsecured promissory note of $5.48 million with an accredited investor. The note carries a 9% annual interest rate and matures in 18 months. The funds will extend the company's cash runway into Q4 2025, supporting clinical, manufacturing, and regulatory activities, including the planned NDA submission for CTx-1301 targeted for mid-2025. The private placement was made under Section 4(a)(2) of the Securities Act and/or Regulation D.
Cingulate Inc. reported Q3 2024 financial results, highlighting a $19.5M increase in working capital. The company raised $12.5M in capital during Q3, extending cash runway into Q3 2025. Net loss decreased to $3.2M from $6.0M year-over-year, with R&D expenses dropping to $1.4M from $3.9M. The company secured European patents for its lead ADHD asset CTx-1301 in up to 30 territories and regained Nasdaq compliance. Cingulate remains on track for mid-2025 New Drug Application submission of CTx-1301.
Shane J. Schaffer, Chairman and CEO of Cingulate (NASDAQ: CING), appeared on the nationally syndicated Big Biz Show to discuss Cingulate's lead Phase 3 asset, CTx-1301, for the treatment of ADHD. Schaffer highlighted the company's Precision Timed Release™ (PTR™) drug delivery platform, which aims to advance next-generation pharmaceutical products. The discussion included plans for the commercialization of CTx-1301 and potential applications of PTR™ technology in other therapeutic areas. The Big Biz Show, hosted by Bob “Sully” Sullivan, is broadcast globally through partners like iHeart Radio and the American Forces Network.
Cingulate Inc. (NASDAQ: CING) has initiated its final FDA-required study for CTx-1301, a dexmethylphenidate-based treatment for ADHD. The food effect study is expected to yield results by the end of 2024. The company has also raised over $10 million in additional capital since mid-August 2024, with 58% coming from its at-the-market facility. This capital infusion strengthens Cingulate's balance sheet and supports the advancement of CTx-1301 towards NDA submission, targeted for mid-2025. Additionally, Cingulate has received notification from Nasdaq confirming its compliance with listing requirements, addressing previous concerns about potential delisting.
Cingulate (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer, PharmD, will participate in a live Benzinga All Access event on August 28, 2024, at 10:30 a.m. CST. Schaffer will discuss the company's recent European patent, the ADHD market, and potential expansion of Cingulate’s Precision Timed Release™ (PTR™) drug delivery platform into other therapeutic areas. The event can be viewed live on Benzinga's YouTube channel and later on Cingulate's website.
Cingulate Inc. (NASDAQ:CING) has adjourned its Special Meeting of Stockholders due to insufficient quorum. The meeting is rescheduled for August 28, 2024, at 11:00 a.m. Central Time. The company's Board of Directors believes all proposals in the proxy statement are in the best interests of stockholders and recommends voting FOR all agenda items. The record date for the Special Meeting remains June 28, 2024. Stockholders can vote live by calling 1-800-652-8683 or online at www.envisionreports.com/CING-SP. Cingulate is a biopharmaceutical company using its Precision Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products.
FAQ
What is the current stock price of Cingulate (CINGW)?
What is Cingulate's primary focus?
What is the Precision Timed Release™ (PTR™) platform?
What is Cingulate's lead product candidate?
How does Cingulate differentiate itself in the pharmaceutical market?
What therapeutic areas is Cingulate exploring beyond ADHD?
What is Cingulate's global expansion strategy?
When does Cingulate plan to submit its NDA for CTx-1301?
What challenges does Cingulate face in its market?
How does Cingulate generate revenue?
What is the significance of Cingulate's recent FDA-required study completion?
