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) 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.
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.
Cingulate Inc. (NASDAQ: CING) has secured a $3 million grant from a private foundation to accelerate the development of CTx-2103 (buspirone) for anxiety treatment. The grant will be distributed in three $1 million tranches, with the first payment scheduled for May 1st and subsequent tranches tied to development milestones.
CTx-2103 aims to be the first once-daily formulation of buspirone in the $5.5 billion U.S. anxiety market ($11.6 billion globally). The foundation will receive quarterly royalties of $500,000 after commercialization, capped at $3.5 million total. The development leverages Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform technology.
This initiative addresses a significant medical need, as anxiety disorders affect approximately 31% of U.S. adults and represent the most common mental health concern in America, according to the National Institutes of Mental Health.
Cingulate Inc. (NASDAQ: CING) has completed a Pre-NDA meeting with the FDA regarding its lead ADHD treatment asset CTx-1301 (dexmethylphenidate HCl). The company remains on schedule for a New Drug Application submission in mid-2025.
The company recently released Phase 3 safety data for CTx-1301 and results from a food effect study using a single 50-mg dose in healthy adults. The safety profile has remained consistent across nine clinical trials. CTx-1301 is positioned to be the first true once-daily stimulant medication for ADHD treatment throughout the active day, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform.
A final analysis combining both adult and pediatric safety and efficacy data will be included in the upcoming NDA submission.
Cingulate reported its full year 2024 and Q4 results, highlighting significant progress towards NDA submission for its ADHD treatment CTx-1301. The company secured a $17.5 million increase in working capital, extending cash runway into Q4 2025. Key developments include:
- Scheduled FDA Pre-NDA meeting for April 2, 2025
- Completed safety data from Phase 3 pediatric and adolescent studies with no serious adverse events
- Finished final FDA-required food effect study
- Secured European patent for CTx-1301
Financial highlights:
- Cash position: $12.2 million as of December 31, 2024
- Working capital: $7.5 million
- R&D expenses decreased to $9.4 million from $15.5 million in 2023
- Net loss reduced to $15.5 million from $23.5 million in 2023