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.
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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.