Cingulate Stock Price, News & Analysis

Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company in the pharmaceutical preparation manufacturing industry. The company focuses on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform. According to company disclosures, Cingulate’s programs target conditions characterized by burdensome daily dosing regimens and suboptimal therapeutic coverage, with an initial emphasis on Attention-Deficit/Hyperactivity Disorder (ADHD) and anxiety and other neuropsychiatric indications.

Cingulate is headquartered in Kansas City, Kansas and its common stock and warrants trade on the Nasdaq Capital Market under the symbols CING and CINGW. The company describes itself as building and advancing a pipeline of product candidates that aim to improve patient outcomes by enabling once-daily dosing where existing therapies often require multiple daily doses.

Business focus and lead program

Cingulate’s lead product candidate is CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release stimulant therapy being evaluated for the treatment of ADHD in children and adults under the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway. CTx-1301 is described as a multi-core tablet designed to deliver three precisely timed releases of active medication across the day using the PTR platform. Company materials state that this design aims to provide rapid onset of effect, entire active-day duration, and a smooth pharmacokinetic profile with a single dose.

CTx-1301 uses dexmethylphenidate, a stimulant active ingredient already approved by the FDA for ADHD in other formulations. Cingulate reports that its formulation is intended to address limitations of current extended-release stimulant products, such as delayed onset, inconsistent duration, and the need for multiple daily doses. Phase 3 clinical data in both adult and pediatric populations, as described in company press releases, showed dose-dependent improvements on established ADHD rating scales and measures of clinical global impression, with safety and tolerability consistent with the stimulant class.

Precision Timed Release™ (PTR™) platform

The PTR™ platform is central to Cingulate’s business model. Company descriptions explain that PTR is a drug delivery technology designed to achieve true once-daily dosing by controlling drug release at specific, pre-defined times. The platform incorporates a proprietary Erosion Barrier Layer (EBL), which is enrobed around a drug-containing core to create a tablet-in-tablet dosage form. The EBL is designed to erode at a controlled rate, allowing drug release from the core only at intended time points, with no release prior to those times.

The EBL formulation, referred to as OralogiK™ or Oralogik™ in company communications, is licensed from BDD Pharma. Cingulate states that it intends to apply its PTR technology beyond ADHD to anxiety disorders and other therapeutic areas where one or more active pharmaceutical ingredients must be delivered several times a day at specific intervals and where improved coverage over existing therapies is desired.

Pipeline and therapeutic areas

Based on company statements, Cingulate is developing a pipeline of next-generation pharmaceutical products built on the PTR platform. The lead candidate, CTx-1301, is in late-stage development for ADHD. The company also references additional candidates in anxiety and other neuropsychiatric indications, and more broadly notes that it is identifying and evaluating additional therapeutic areas where PTR may be employed to develop future product candidates.

The company’s disclosures emphasize conditions where patients often face burdensome daily dosing regimens and where existing treatments may not provide consistent therapeutic coverage throughout the day. ADHD is highlighted as an area where many patients require multiple doses and may experience gaps in symptom control; Cingulate positions CTx-1301 as a once-daily option designed to provide symptom relief across the entire active day.

Regulatory and clinical development

Cingulate reports that it submitted a New Drug Application (NDA) for CTx-1301 to the FDA on July 31, 2025. In October 2025, the FDA accepted the NDA for review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. Company communications describe this as a key regulatory milestone that follows completion of adult and pediatric Phase 3 trials and all FDA-requested studies, along with a positive pre-NDA meeting confirming adequacy of the clinical and Chemistry, Manufacturing, and Controls (CMC) packages for review.

In its Phase 3 program, Cingulate reports that CTx-1301 achieved its primary endpoints in pediatric studies, demonstrating dose-dependent improvements on the ADHD Rating Scale-5 (ADHD-RS-5) and Clinical Global Impression-Severity (CGI-S) scales, and showing rapid onset and sustained efficacy into the evening hours. Adult studies are described as showing clinically meaningful improvements on measures such as the Permanent Product Measure of Performance (PERMP) and Adult ADHD Investigator Symptom Rating Scale (AISRS). Across studies, the company reports no serious treatment-emergent adverse events and a tolerability profile consistent with other long-acting methylphenidate products.

Manufacturing and commercialization preparations

As part of its preparation for potential commercialization, Cingulate has disclosed an exclusive commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301 in the United States through 2028, if the product is approved by the FDA. Under this agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer, and Cingulate has committed to purchase 100% of its overall U.S. commercial supply of CTx-1301 from Bend, following and subject to any FDA approval. Company statements indicate that process transfer and scale-up production using commercial-grade equipment have been completed to support potential launch.

On the commercial side, Cingulate has announced a partnership with Indegene, described as a digital-first life sciences commercialization company. This collaboration is intended to support launch readiness, commercial infrastructure, market access execution, and prescriber and patient engagement using an AI-driven, data-rich platform. Cingulate has also highlighted internal commercial leadership appointments, including naming a Chief Commercial Officer to guide launch preparation for CTx-1301.

Capital markets and corporate profile

Cingulate is a publicly traded company listed on the Nasdaq Capital Market. It has used a variety of financing arrangements, including a purchase agreement with Lincoln Park Capital for potential equity sales over a multi-year term and a non-convertible unsecured promissory note with Avondale Capital, as described in its SEC filings. Company communications note that proceeds from such financings are intended for working capital and general corporate purposes, including advancing commercialization efforts for CTx-1301.

The company’s SEC filings and press releases also describe governance and executive changes, including the appointment and reinstatement of senior executives, but these events do not alter the core description of Cingulate as a biopharmaceutical company focused on PTR-based therapies for ADHD and related conditions.

Position within the ADHD treatment landscape

In its public statements, Cingulate characterizes ADHD as a chronic neurodevelopmental or neurobiological disorder affecting an estimated 20 million individuals in the U.S., including children and adults. The company notes that stimulant medications remain the gold-standard therapy, yet many existing extended-release formulations require multiple daily doses and may not provide consistent coverage across the entire active day. Within this context, CTx-1301 is presented as a once-daily, extended-release dexmethylphenidate tablet designed to deliver rapid onset and entire active-day symptom control through three timed releases from a single tablet.

By focusing on once-daily dosing and controlled release profiles, Cingulate’s PTR-based approach is intended, according to company materials, to address practical challenges such as adherence, midday symptom rebound, and the need for supplemental doses. The same platform is being explored for anxiety disorders and other indications where similar dosing challenges exist.

Summary

Overall, Cingulate Inc. is described in its own disclosures as a Nasdaq-listed, Kansas City–based biopharmaceutical company centered on the Precision Timed Release™ platform. Its lead candidate, CTx-1301, is in late-stage regulatory review for ADHD under the 505(b)(2) pathway, supported by Phase 3 data in adult and pediatric populations. Through its PTR technology, exclusive U.S. manufacturing partnership with Bend Bio Sciences, and commercialization collaboration with Indegene, Cingulate aims to develop and potentially commercialize once-daily treatments for ADHD and other conditions where improved dosing convenience and coverage are needed.