Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)
CTx-2103 Development: Cingulate Inc. has received a $3 million grant to accelerate the development of CTx-2103, a once-daily formulation of buspirone aimed at treating anxiety disorders, which could help reduce reliance on benzodiazepines.
Precision Timed Release™ Technology: The drug utilizes Cingulate's proprietary Precision Timed Release™ platform, designed to improve dosing regimens for patients suffering from anxiety and ADHD, addressing a significant unmet medical need in mental health.
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Cingulate Inc. Announces Financial Results for Q2 2025 and Shares Recent Developments
New Drug Application Submission: Cingulate Inc. submitted a New Drug Application (NDA) to the FDA for CTx-1301, an extended-release tablet formulation of dexmethylphenidate aimed at improving ADHD treatment.
FDA Decision Timeline: The FDA is expected to make a decision on the NDA acceptance by Q4 2025, with a potential PDUFA date in mid-2026.
Financial Overview: As of June 30, 2025, Cingulate reported $8.9 million in cash and working capital of approximately $3.5 million, alongside a net loss of $4.8 million for the quarter.
Research and Development Focus: The company is increasing R&D expenses due to clinical and regulatory activities related to the NDA submission, while also exploring additional therapeutic areas for its Precision Timed Release™ platform technology.
FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301
Pre-NDA Meeting Outcome: Cingulate Inc. has received formal pre-New Drug Application (NDA) meeting minutes from the FDA, indicating alignment with their plans to submit an NDA for their ADHD treatment, CTx-1301, this summer.
CTx-1301 Overview: CTx-1301 utilizes Cingulate's Precision Timed Release™ technology to provide a once-daily stimulant medication for ADHD, designed to deliver multiple doses throughout the day for optimal efficacy.
Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)
CTx-2103 Development: Cingulate Inc. has received a $3 million grant to accelerate the development of CTx-2103, a once-daily formulation of buspirone aimed at treating anxiety disorders, which could help reduce reliance on benzodiazepines.
Precision Timed Release™ Technology: The drug utilizes Cingulate's proprietary Precision Timed Release™ platform, designed to improve dosing regimens for patients suffering from anxiety and ADHD, addressing a significant unmet medical need in mental health.
Final Study Completed for Cingulate's Lead Asset CTx-1301
FDA Study Completion: Cingulate Inc. has completed its final FDA-required food effect study for CTx-1301, a medication for ADHD, with no serious adverse events reported; results are expected in Q2 2025 and the New Drug Application is targeted for mid-2025.
CTx-1301 Overview: CTx-1301 utilizes Cingulate's Precision Timed Release™ technology to provide a once-daily stimulant treatment for ADHD, aiming for effective symptom management throughout the day with a unique multi-core formulation.
Cingulate Reports Third Quarter 2024 Financial Results Reflecting $19.5 Million Increase in Working Capital to Advance ADHD Drug to Market
Financial Update: Cingulate Inc. reported a net loss of $3.2 million for Q3 2024, significantly reduced from $6.0 million in the same period last year, while raising approximately $12.5 million in capital to support its operations and advance its lead ADHD treatment, CTx-1301, with an NDA submission targeted for mid-2025.
Patent and Compliance News: The company received a European patent for CTx-1301 across up to 30 territories, enhancing its market potential, and confirmed compliance with Nasdaq's minimum bid price requirement, indicating improved financial stability.
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
Cingulate Inc. Advances ADHD Treatment: Cingulate Inc. has initiated its final FDA-required food effect study for CTx-1301, a treatment for ADHD, with results expected by the end of 2024, while also raising over $10 million in capital to support its development efforts.
Innovative Drug Delivery Technology: The company's proprietary Precision Timed Release™ (PTR™) platform aims to enhance ADHD treatment efficacy through a multi-core formulation that provides controlled medication release throughout the day, addressing the limitations of existing stimulant therapies.
Cingulate Inc. Announces Financial Results for Q2 2025 and Shares Recent Developments
New Drug Application Submission: Cingulate Inc. submitted a New Drug Application (NDA) to the FDA for CTx-1301, an extended-release tablet formulation of dexmethylphenidate aimed at improving ADHD treatment.
FDA Decision Timeline: The FDA is expected to make a decision on the NDA acceptance by Q4 2025, with a potential PDUFA date in mid-2026.
Financial Overview: As of June 30, 2025, Cingulate reported $8.9 million in cash and working capital of approximately $3.5 million, alongside a net loss of $4.8 million for the quarter.
Research and Development Focus: The company is increasing R&D expenses due to clinical and regulatory activities related to the NDA submission, while also exploring additional therapeutic areas for its Precision Timed Release™ platform technology.
FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301
Pre-NDA Meeting Outcome: Cingulate Inc. has received formal pre-New Drug Application (NDA) meeting minutes from the FDA, indicating alignment with their plans to submit an NDA for their ADHD treatment, CTx-1301, this summer.
CTx-1301 Overview: CTx-1301 utilizes Cingulate's Precision Timed Release™ technology to provide a once-daily stimulant medication for ADHD, designed to deliver multiple doses throughout the day for optimal efficacy.
Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)
CTx-2103 Development: Cingulate Inc. has received a $3 million grant to accelerate the development of CTx-2103, a once-daily formulation of buspirone aimed at treating anxiety disorders, which could help reduce reliance on benzodiazepines.
Precision Timed Release™ Technology: The drug utilizes Cingulate's proprietary Precision Timed Release™ platform, designed to improve dosing regimens for patients suffering from anxiety and ADHD, addressing a significant unmet medical need in mental health.
Final Study Completed for Cingulate's Lead Asset CTx-1301
FDA Study Completion: Cingulate Inc. has completed its final FDA-required food effect study for CTx-1301, a medication for ADHD, with no serious adverse events reported; results are expected in Q2 2025 and the New Drug Application is targeted for mid-2025.
CTx-1301 Overview: CTx-1301 utilizes Cingulate's Precision Timed Release™ technology to provide a once-daily stimulant treatment for ADHD, aiming for effective symptom management throughout the day with a unique multi-core formulation.
Cingulate Reports Third Quarter 2024 Financial Results Reflecting $19.5 Million Increase in Working Capital to Advance ADHD Drug to Market
Financial Update: Cingulate Inc. reported a net loss of $3.2 million for Q3 2024, significantly reduced from $6.0 million in the same period last year, while raising approximately $12.5 million in capital to support its operations and advance its lead ADHD treatment, CTx-1301, with an NDA submission targeted for mid-2025.
Patent and Compliance News: The company received a European patent for CTx-1301 across up to 30 territories, enhancing its market potential, and confirmed compliance with Nasdaq's minimum bid price requirement, indicating improved financial stability.
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
Cingulate Inc. Advances ADHD Treatment: Cingulate Inc. has initiated its final FDA-required food effect study for CTx-1301, a treatment for ADHD, with results expected by the end of 2024, while also raising over $10 million in capital to support its development efforts.
Innovative Drug Delivery Technology: The company's proprietary Precision Timed Release™ (PTR™) platform aims to enhance ADHD treatment efficacy through a multi-core formulation that provides controlled medication release throughout the day, addressing the limitations of existing stimulant therapies.
