ROTH MKM initiated coverage of Cingulate with a rating of Buy and set a new price target of $12.00

Laidlaw downgraded Cingulate from Buy to Hold

Laidlaw & Co. initiated coverage of Cingulate with a rating of Buy and set a new price target of $8.50

Aegis Capital initiated coverage of Cingulate with a rating of Buy and set a new price target of $9.00

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Jennifer Callahan, Chief Financial Officer, appointed Interim CEO Board member, Jay Roberts appointed Executive Chairman KANSAS CITY, Kan., Aug. 15, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:CING) The Board of Directors of Cingulate Inc. ("Cingulate") announced that it has placed Chairman and Chief Executive Officer, Shane J. Schaffer, PharmD, on administrative leave in connection with ongoing legal matters unrelated to the company and its operations. In addition, Jennifer Callahan, Cingulate's Chief Financial Officer, has been appointed interim CEO to ensure business continuity and operational stability. Ms. Callahan will retain her responsibilities as Chief Financial Officer. Healthcare in

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301(dexmethylphenidate HCl), the company's lead asset for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver fast onset, entire active-day efficacy, and a smooth pharmacokinet

KANSAS CITY, Kan., July 29, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for lead asset CTx-1301 (dexmethylphenidate HCI) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act),

KANSAS CITY, Kan., July 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, has named Nilay Patel, JD, as Chief Legal Officer. Patel's appointment comes as Cingulate plans to submit a new drug application to the FDA in coming weeks for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Mr. Patel brings more than two decades of legal and compliance leadership in the pharmaceutical industry, having advised companies across

Industry Leader with 30+ Years of Experience Will Drive Strategic Growth and Partnerships SCOTTSDALE, Ariz., May 27, 2025 /PRNewswire/ -- Life365, a leading data engagement and virtual care company, today announced the appointment of healthcare executive and investor Jay Roberts as chief development officer. Roberts, who previously served as an executive advisor to Life365, brings more than 30 years of strategic healthcare leadership experience to this pivotal role. Life365's platform enables the next generation of AI-driven healthcare for enterprise healthcare organizations,

Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on "Unboxing Biotech" Podcast KANSAS CITY, Kan., May 20, 2025 (GLOBE NEWSWIRE) --  Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced the efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17), for its lead asset CTx-1301 (dexmethylphenidate HCl) for the tre

Pre-NDA Minutes from April 2, 2025, Meeting Received NDA Submission Planned this Summer KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) for it's lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). "We are pleased that the feedback we received from our pre-NDA meeting wit

Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025 Non-Dilutive Funding to Accelerate Development of CTx-2103 (buspirone) KANSAS CITY, Kan., May 08, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended March 31, 2025, and provided a clinical and business update. Highlights include the completion of the Pre-NDA meeting for CTx-1301 and grant received to accelerate

Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD KANSAS CITY, Kan., April 29, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced positive top-line results from the CTx-1301-013 study, an FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formul

CTx-2103 has the Potential to be the First, Once-Daily Formulation of Buspirone, one of the Most Widely Prescribed Agents in the $5.5 Billion U.S. Anxiety Market, and the $11.6 Billion Anxiety Market Worldwide Non-Dilutive Funding Expands Pipeline and Further Validates Cingulate's Proprietary Precision Timed Release™ Drug Delivery Technology CTx-2103 has the Potential to Reduce Use of Benzodiazepine's and Associated Withdrawal and Dependency Issues KANSAS CITY, Kan., April 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advanc

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KANSAS CITY, Kan., July 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, has named Nilay Patel, JD, as Chief Legal Officer. Patel's appointment comes as Cingulate plans to submit a new drug application to the FDA in coming weeks for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Mr. Patel brings more than two decades of legal and compliance leadership in the pharmaceutical industry, having advised companies across

Industry Leader with 30+ Years of Experience Will Drive Strategic Growth and Partnerships SCOTTSDALE, Ariz., May 27, 2025 /PRNewswire/ -- Life365, a leading data engagement and virtual care company, today announced the appointment of healthcare executive and investor Jay Roberts as chief development officer. Roberts, who previously served as an executive advisor to Life365, brings more than 30 years of strategic healthcare leadership experience to this pivotal role. Life365's platform enables the next generation of AI-driven healthcare for enterprise healthcare organizations,

KANSAS CITY, Kan., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has appointed three new directors to its board: Jay Roberts, Bryan Lawrence, and Jeff Ervin. The appointment of the new directors follows the completion of the Company's recent follow-on offering of $7.5 million in February 2024, sales under the Company's at-the-market offering (ATM) facility in January 2024 of $3.2 million, as well as the conversion of $3.3 million of outstanding debt i

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Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025 Non-Dilutive Funding to Accelerate Development of CTx-2103 (buspirone) KANSAS CITY, Kan., May 08, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended March 31, 2025, and provided a clinical and business update. Highlights include the completion of the Pre-NDA meeting for CTx-1301 and grant received to accelerate

KANSAS CITY, Kan., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the three months ended September 30, 2024, and provided a clinical and business update. "The capital raised this quarter has allowed us to focus on advancing the remaining activities required for NDA submission of our lead ADHD asset, CTx-1301, targeted for mid 2025," said Cingulate Chairman and CEO Shane J. Schaffer. "The granting of European patents for CTx-1301 in up to

CTx-1301 Phase 3 Adult Dose-Optimization Study Ongoing; Results Expected 3Q 2023 Positive Top-Line Data from CTx-1301 Fed/Fast Study Announced, Full Results Submitted for Presentation at Forthcoming Medical Meeting CTx-1301 Pivotal Phase 3 Trial in Pediatric/Adolescent Patients Planned to Begin Mid-2023 KANSAS CITY, Kan., March 10, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the three and 12 months ended December 31, 2022, and provided a clin

Phase 3 Trial Initiation for Lead ADHD Candidate CTx-1301 in December 2022 Executed Manufacturing Agreement with Societal CDMO 2022 Psych Congress Presentation Demonstrated Ability of Anxiety Candidate CTx-2103 to Deliver a Single Administration of Triple-Release Buspirone KANSAS CITY, Kan., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended September 30, 2022 and provided a clinical and business update. Highlights include

$5 Million of Non-Dilutive FinancingVeteran Biotech Executive Appointed to Board KANSAS CITY, Kan., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended June 30, 2022, and provided a clinical and business update. Highlights include the announcement of $5 million of debt financing and the appointment of an additional member to Cingulate's Board of Directors. "Cingulate continues to advance its mission in bringin

KANSAS CITY, Kan., May 12, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the three months ended March 31, 2022, and provided a clinical and business update, which includes the announcement of first subject dosing in its human formulation study of CTx-2103 (buspirone) for the treatment of anxiety. "At its core, Cingulate has maintained a primary focus on addressing patients' suboptimal treatment outcomes and overcoming unmet needs d