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 (NASDAQ: CING) announced significant management changes as Chairman and CEO Shane J. Schaffer has been placed on administrative leave due to legal matters unrelated to the company. Jennifer Callahan, the company's CFO, has been appointed as interim CEO while maintaining her CFO duties. Additionally, board member Jay Roberts has been named Executive Chairman.
The company recently submitted a new drug application to the FDA in July for CTx-1301, their ADHD treatment candidate. The management team includes experienced executives Dr. Matt Brams (Co-Founder and CMO), Dr. Raul Silva (Co-Founder and CSO), and Nilay Patel (CLO).
Cingulate Inc. (NASDAQ: CING) has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment candidate. The drug, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) platform, is designed to provide once-daily dosing with fast onset and entire active-day efficacy.
CTx-1301 is a novel extended-release formulation of dexmethylphenidate HCl that aims to address major limitations of current ADHD therapies. The company expects to receive notification of NDA acceptance within 60 days of its July 31 submission. The drug targets the $23 billion U.S. ADHD market and represents the first regulatory application of Cingulate's PTR™ platform technology.
Cingulate (NASDAQ: CING) has received a significant PDUFA fee waiver of $4.3 million from the FDA for its upcoming New Drug Application (NDA) for CTx-1301, its lead ADHD treatment asset. The waiver, granted through the small business provision of the FD&C Act, comes just days before the company's planned NDA submission at the end of July 2025.
CTx-1301 (dexmethylphenidate HCI) is developed using Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform technology. The fee waiver will strengthen the company's financial position as it moves toward commercialization of its ADHD treatment candidate.
Cingulate Inc. (NASDAQ: CING) has appointed Nilay Patel, JD as Chief Legal Officer as the company prepares to submit a New Drug Application (NDA) for its ADHD treatment CTx-1301. Patel brings over 20 years of pharmaceutical industry experience, most recently serving as Chief Legal Officer at Ironshore Pharmaceuticals.
The appointment comes at a crucial time as Cingulate plans to file its NDA for CTx-1301 (dexmethylphenidate HCl) in the coming weeks. The company granted Patel stock options for 30,000 shares at $4.51 per share, vesting over four years with 25% vesting after the first year and the remainder monthly over 36 months.
Life365 has appointed healthcare veteran Jay Roberts as Chief Development Officer to drive strategic growth and partnerships. Roberts, who previously served as an executive advisor to Life365, brings over 30 years of healthcare leadership experience to the role. In his new position, he will focus on securing funding, building strategic partnerships, and fostering stakeholder relationships to accelerate market expansion.
Roberts currently serves as a partner with Ventac Partners and as a venture partner for DigiLife Fund II. His extensive experience includes CEO, COO, and CFO positions at Nasdaq-traded companies, involvement in over 50 M&A and financing transactions, and board positions at various healthcare companies including Cingulate (CING). He previously served as president and CEO of Vyant Bio and held leadership roles at Cancer Genetics and VirMedica.
Cingulate Inc. (NASDAQ: CING) has received formal pre-New Drug Application (NDA) meeting minutes from the FDA for CTx-1301, its lead ADHD treatment asset. The company plans to submit the NDA this summer following positive feedback from the April 2, 2025 meeting. CTx-1301, a dexmethylphenidate-based medication, is positioned as the first true once-daily stimulant for full-day ADHD treatment.
Key FDA agreements include: post-NDA approval commitment for additional stability data on 6 intermediate dose strengths, expected 24-month shelf-life at launch, adequacy of nonclinical safety data, ability to rely on Focalin XR's efficacy and safety data, and acceptance of the company's approach to integrated safety and efficacy summaries.
Cingulate Inc. (NASDAQ: CING) reported its Q1 2025 financial results and provided key updates on its drug development pipeline. The company completed a Pre-NDA meeting with the FDA for its lead ADHD asset CTx-1301 on April 2, 2025, maintaining its timeline for NDA submission in mid-2025. Recent Phase 3 safety data and food effect studies showed positive results for CTx-1301.
The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103 (buspirone) for anxiety treatment, to be paid in three $1 million installments. As of March 31, 2025, Cingulate had $9.5 million in cash, providing runway into Q4 2025. The company reported a Q1 2025 net loss of $3.8 million, up from $3.0 million in Q1 2024, with R&D expenses at $2.2 million and G&A expenses at $1.5 million.
Cingulate has announced positive top-line results from its high-dose study of CTx-1301, a treatment for ADHD. The study focused on the 50mg dose of their lead candidate, examining how food affects its absorption.
The trial enrolled 27 healthy adults aged 18-50 years, testing the drug both with a high-fat breakfast and on an empty stomach. Key findings show that CTx-1301 can be taken with or without food, though patients should maintain consistency in their dosing approach.
The drug utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology and is designed as the first true once-daily stimulant medication for entire-day ADHD treatment. It offers eight dose strengths for optimal patient customization. The study measured pharmacokinetic parameters including maximum plasma concentration (Cmax) and total drug absorption (AUC), with results showing favorable tolerability and consistent adverse events with previous findings.