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 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.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will speak at the Benzinga All Access event on August 19, 2022, at 9 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 treatment. The event can be viewed live on Benzinga’s YouTube channel and on Cingulate’s investor website.
Cingulate is dedicated to improving treatment outcomes for patients through innovative drug delivery technology.
Cingulate Inc. (NASDAQ: CING) announced its Q2 financial results, highlighting a $5 million non-dilutive debt financing and the appointment of Scott Applebaum to its Board of Directors. As of June 30, 2022, Cingulate's cash and equivalents stood at $8.2 million. R&D expenses rose to $2.2 million, while G&A expenses increased to $1.9 million, leading to a net loss of $4 million for the quarter. The company plans to continue development of its ADHD treatment, CTx-1301, with a Phase 3 study expected to commence soon. Positive NDA filing anticipated by late 2023 requires additional capital of $16.5 million.
Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company, announced that its CFO, Lou Van Horn, was honored as a 2022 CFO of the Year by the Kansas City Business Journal. This is the second time Lou has received this accolade, recognizing his financial leadership and expertise. The award ceremony took place on July 22, 2022. Lou, who played a crucial role in Cingulate's IPO in 2021, expressed gratitude for the recognition and highlighted the positive economic outlook for the Kansas City region.
Cingulate Inc. has announced the completion of the formulation study for CTx-2103, a new once-daily treatment for anxiety-related disorders using its proprietary Precision Timed Release™ (PTR™) drug delivery technology. This study, conducted in the UK, aims to improve adherence by reducing the dosing frequency of the active ingredient, buspirone. Results are anticipated in August 2022. CTx-2103 is designed to offer significant advantages over existing medications while addressing a substantial market need, as anxiety disorders affect approximately 31% of U.S. adults at some point in their lives.
Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company, will present a company overview at the Diamond Equity Research 2022 Virtual Emerging Growth Invitational on June 23, 2022, at 1:40 PM EST. Chairman and CEO, Shane J. Schaffer, PharmD, will lead the presentation and follow up with a Q&A session. Investors can register for the event and access live webcasts via the provided links. Cingulate focuses on its proprietary Precision Timed Release™ (PTR™) drug delivery technology for developing next-generation products, initially targeting ADHD.
Cingulate Inc. (NASDAQ: CING) has announced that its Chairman and CEO, Shane J. Schaffer, and scientific advisor, Dr. Ann Childress, will participate in a live event on June 3, 2022, at 8:45 a.m. CST, hosted by Benzinga. 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. This event can be accessed via Benzinga’s YouTube channel and Cingulate's website.
Cingulate Inc. (NASDAQ: CING) announced the completion of enrollment in a clinical study for CTx-2103, a novel buspirone formulation aimed at treating anxiety disorders. This study, initiated in May 2022 with 12 participants, is set to yield results in July 2022. CTx-2103 employs Cingulate's proprietary Precision Timed Release™ (PTR™) technology, enabling once-daily dosing. The formulation could address issues of nonadherence prevalent with current treatments, offering potential for improved patient outcomes in a significant $5.5B U.S. anxiety market.
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