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.
Cingulate Inc. (CINGW) generates news primarily as a clinical-stage biopharmaceutical company advancing its Precision Timed Release™ (PTR™) drug delivery platform and lead ADHD asset, CTx-1301. News coverage for Cingulate often centers on regulatory milestones, clinical data disclosures, financing activities, and steps toward commercialization of its once-daily stimulant formulation.
Investors following CINGW news will see updates on CTx-1301’s regulatory path, including the submission and FDA acceptance of the New Drug Application (NDA) under the 505(b)(2) pathway and the assignment of a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. Press releases also highlight Phase 3 clinical results in adult and pediatric ADHD populations, with reported dose-dependent improvements on standard ADHD rating scales and sustained efficacy into evening hours, as well as safety findings consistent with other long-acting methylphenidate products.
Cingulate’s news flow also covers corporate and commercial developments, such as the appointment of senior executives to support launch preparation, exclusive manufacturing and supply agreements with Bend Bio Sciences for CTx-1301, and a commercialization partnership with Indegene built around an AI-driven, digital-first platform. Financing announcements, including a committed equity facility with Lincoln Park Capital and debt-related transactions, appear in both press releases and related SEC filings and can influence the company’s capital position ahead of potential commercialization.
In addition, Cingulate issues regular quarterly financial updates that summarize research and development spending, general and administrative expenses, net loss, and cash runway expectations, often alongside clinical and regulatory highlights. For those tracking developments in ADHD therapeutics and PTR™-based drug delivery, the CINGW news stream provides a consolidated view of Cingulate’s progress from late-stage development toward a possible commercial phase, subject to FDA review outcomes.
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.
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.
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