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.
Cingulate Inc. (NASDAQ: CING) generates frequent news as a clinical-stage biopharmaceutical company advancing its Precision Timed Release™ (PTR™) platform and lead ADHD candidate, CTx-1301. This news page aggregates company press releases, analyst coverage, and regulatory updates so readers can follow key developments in Cingulate’s late-stage clinical and regulatory journey.
Recent announcements highlight major milestones for CTx-1301, including submission and FDA acceptance of the New Drug Application under the 505(b)(2) pathway, assignment of a Prescription Drug User Fee Act (PDUFA) target action date, and positive Phase 3 trial results in adult and pediatric ADHD populations. News items also cover presentations of clinical data at scientific meetings, such as podium presentations at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting.
Investors and followers of CING can use this page to track quarterly financial results, capital-raising transactions, and material agreements disclosed through press releases and referenced in Form 8-K filings. Examples include commercial supply agreements with Bend Bio Sciences, commercialization partnerships with Indegene, and financing arrangements such as promissory notes and equity purchase agreements.
Corporate updates, including executive appointments in commercial leadership and board-level changes, are also reflected in Cingulate’s news flow. Together, these items provide context on how the company is preparing for potential commercialization of CTx-1301 and expanding its PTR-based pipeline in ADHD, anxiety, and other neuropsychiatric indications. Bookmark this page to review new CING headlines, clinical data disclosures, regulatory milestones, and business updates as they are released.
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.
Cingulate Inc. (NASDAQ: CING) announced the completion of a study assessing the effect of food on the absorption of its lead candidate, CTx-1301, for treating ADHD. Conducted by Dr. Vince Clinical Research, the study involved 26 healthy adults in both fasted and fed states. Results are anticipated by year-end. The findings aim to enhance understanding of CTx-1301's bioavailability and support its upcoming NDA submission expected in late 2023 or early 2024. Cingulate is advancing its proprietary Precision Timed Release technology for improved ADHD treatment outcomes.
Cingulate Inc. (NASDAQ: CING) announced a Master Services Agreement (MSA) with Societal CDMO to enhance its manufacturing capabilities. Societal CDMO will produce clinical and commercial batches for CTx-1301, a leading candidate for treating ADHD, at its Gainesville, GA facility. This partnership is expected to streamline the production process as Cingulate prepares for a Phase 3 dose-optimization study for CTx-1301, set to start in December 2022. If successful, a New Drug Application (NDA) is planned for submission in early 2024.
Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, announced that Chairman & CEO Shane J. Schaffer will present at the LD Micro Main Event XV investor conference on October 26, 2022, at 10:00 a.m. PT. The event will take place at the Luxe Sunset Boulevard Hotel in Los Angeles, with live streaming available at this link. The company, utilizing its Precision Timed Release™ (PTR™) technology, focuses on developing next-generation pharmaceutical products for neurological disorders and other therapeutic areas.
Cingulate Inc. (NASDAQ: CING) announced findings from a formulation study for CTx-2103, a once-daily buspirone treatment for anxiety disorders, presented at the 2022 Psych Congress. The study demonstrated the ability of CTx-2103 to deliver a triple-release formulation, enhancing patient compliance and treatment outcomes. The CEO emphasized the importance of formulation development in achieving effective medications. CTx-2103 aims to provide benefits over existing treatments by eliminating the need for multiple daily doses.