Cingulate Inc Stock Price, News & Analysis

Cingulate (NASDAQ: CING) announced positive Phase 3 clinical trial results for CTx-1301 (dexmethylphenidate) in treating ADHD in pediatric patients aged 6-17. The study demonstrated statistically significant improvements in ADHD symptoms across all fixed doses (18.75-mg, 25-mg, and 37.5-mg), achieving effect sizes of 0.737 to 1.185 within 5 weeks. The drug, utilizing Cingulate's proprietary Precision Timed Release™ platform, showed promising results in the randomized, double-blind, placebo-controlled trial. A recent food effect study confirmed CTx-1301 can be taken with or without food, and previous Phase 3 safety data showed consistent safety profiles across eight clinical trials. The company plans to submit a New Drug Application (NDA) this summer, with expectations to launch CTx-1301 in eight dosage strengths, six targeting patients under 18.

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

Cingulate (NASDAQ: CING) has announced positive safety results from its final Phase 3 trials for CTx-1301, their lead ADHD treatment asset. The data encompasses two Phase 3 pediatric and adolescent studies (fixed dose and dose optimization) and a food effect study with healthy adults using a 50mg dose.

Key safety findings show no serious treatment emergent adverse events (TEAEs) or deaths, with no clinically relevant trends in TEAEs overall. The food effect study's medical findings align with previous 25mg dose results, indicating CTx-1301 can be taken with or without food.

The company has submitted these results to the FDA ahead of an in-person Pre-NDA meeting scheduled for April 2, 2025. Cingulate plans to file for FDA approval in mid-2025, positioning CTx-1301 as the first true once-daily stimulant medication for treating ADHD throughout the entire active day.

Cingulate Inc. (NASDAQ: CING) has completed its final FDA-required food effect study for CTx-1301, its lead ADHD treatment drug. The study evaluated a single 50mg dose of CTx-1301 (dexmethylphenidate) to determine if the medication can be taken with or without food, with no serious adverse events reported.

Data readout regarding bioavailability is expected in Q2 2025. A previous study in 2022 with a 25mg dose demonstrated that CTx-1301 could be taken regardless of food intake. The company is developing CTx-1301 to be the first true once-daily stimulant medication for ADHD treatment over an entire active day. Cingulate targets submission of the New Drug Application (NDA) to the FDA by mid 2025.