Buspirone | Jotup

Cingulate to Participate in Benzinga All Live Access Event

Retrieved on:

Tuesday, March 19, 2024

KANSAS CITY, Kan., March 19, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that Chairman and CEO Shane J. Schaffer will participate in a live Benzinga All Access event on Friday March 22, 2024, at 12 p.m.

Key Points:

KANSAS CITY, Kan., March 19, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that Chairman and CEO Shane J. Schaffer will participate in a live Benzinga All Access event on Friday March 22, 2024, at 12 p.m.
ET.
Dr. Schaffer will also provide a company overview and recap recent Cingulate clinical and business updates.
The event may be viewed live on Benzinga’s YouTube channel, Benzinga All Access , and will also be available for viewing on Cingulate’s website at cingulate.com/investors .

Cingulate to Attend DCAT Week 2024 in New York City

Retrieved on:

Wednesday, March 6, 2024

Anxiety, DCAT, Chemical substance, Cingulata, Buspirone, ADHD, Drug

KANSAS CITY, Kan., March 06, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it will be attending DCAT Week (Drug, Chemical & Associated Technologies Association) March 18-21, 2024, in Midtown Manhattan.

Key Points:

KANSAS CITY, Kan., March 06, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it will be attending DCAT Week (Drug, Chemical & Associated Technologies Association) March 18-21, 2024, in Midtown Manhattan.
Cingulate Chairman and CEO Shane J. Schaffer, and Cingulate COO Laurie A. Myers, will be joined at the DCAT by Global PharmaPartners, INC. (also known worldwide as “GPP”) to host meetings regarding Cingulate’s pipeline and product portfolio, including its lead Phase 3 candidate CTx-1301 (dexmethylphenidate) for the treatment of attention deficit/hyperactivity disorder (ADHD), and CTx-2103 (buspirone) for the treatment of anxiety.
“Cingulate is excited to be attending DCAT this year with Global PharmaPartners, Inc. to seek out business partnerships with excellent co-development/commercial parties, and we believe it’s an excellent venue to discuss our leading assets, pipeline, and disruptive drug delivery platform technology,” Schaffer said.
Where: Omni Berkshire Place Hotel : 21 E 52nd St Madison Ave, New York City, NY 10022-5389

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on:

Wednesday, January 24, 2024

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points:

Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on:

Wednesday, January 24, 2024

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points:

Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

Cingulate Receives Guidance from FDA on Path Forward for Anxiety Asset CTx-2103 (buspirone)

Retrieved on:

Friday, December 1, 2023

Food, Anxiety disorder, Risk, IND, Drug discovery, FDA, Half-life, NDA, Pharmacokinetics, Anxiety, Gastrointestinal tract, Tablet, Patient, Cingulata, Buspirone, Pharmaceutical industry

“Cingulate received input from the FDA regarding the regulatory pathway for CTx-2103, including filing an Investigational New Drug (IND) application in the first half of 2024 and the design of clinical studies,” said Cingulate Chairman and CEO Shane J. Schaffer.

Key Points:

“Cingulate received input from the FDA regarding the regulatory pathway for CTx-2103, including filing an Investigational New Drug (IND) application in the first half of 2024 and the design of clinical studies,” said Cingulate Chairman and CEO Shane J. Schaffer.
CTx-2103 is a once-daily, multi-dose tablet that provides three precisely timed doses of buspirone versus one immediate release dose.
In September 2022, Cingulate completed a formulation study in which the pharmacokinetics of CTx-2103 were evaluated.
Based on the data from this study, CTx-2103 provides three timed releases of buspirone, as it was designed to do.

MIRA Pharmaceuticals Releases Breakthrough Data from Artificial Intelligence Simulations

Retrieved on:

Monday, December 4, 2023

BALTIMORE, Dec. 4, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC.

Key Points:

The simulations on MIRA1a were conducted in conjunction with the Company's strategic collaboration with InSilicoTrials , a company specializing in leveraging AI and simulations to enhance drug and medical device development.
In silico analysis is a computational technique that uses AI to predict the interaction between drugs and their targets.
The simulations suggest that MIRA1a's agonistic action on the 5-HT1a receptor aligns with established anxiolytic properties in medications like Buspirone and certain SSRIs.
"In the groundbreaking field of neuropharmacology, artificial intelligence and machine learnings have ushered in a new era of drug discovery and analysis," said Adam Kaplin, MD, Ph.D., President and Chief Scientific Officer of MIRA Pharmaceuticals.

Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on:

Monday, August 14, 2023

KANSAS CITY, Kan., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended June 30, 2023, as well as a clinical and business update. Among other highlights, the Company announced a $1 million dollar investment from Werth Family Investment Associates LLC (WFIA), top-line results following the completion of a Phase 3 Adult Efficacy and Safety Trial of CTx-1301, and the initiation of the CTx-1301 Phase 3 pediatric and adolescent studies.

Key Points:

CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
As part of that effort:
Cingulate completed a Phase 3 adult dose-optimization study in June 2023 and announced top-line results in July 2023.
Assuming positive clinical results from the upcoming Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.
Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures into September 2023.

Cingulate Inc. Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on:

Wednesday, May 10, 2023

KANSAS CITY, Kan., May 10, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the three months ended March 31, 2023, as well as a clinical and business update. Among other highlights, the Company announced it has obtained an additional $3 million of debt financing, successfully completed the transfer of its proprietary PTR™ manufacturing processes to Societal CDMO, Inc. (Societal) and entered into a joint commercialization agreement with Indegene to provide commercial support for CTx-1301 upon approval from the U.S. Food and Drug Administration (FDA).

Key Points:

CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit the NDA for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
Cash Position: As of March 31, 2023, Cingulate had $1.7 million in cash and cash equivalents.
This decrease in manufacturing expense was slightly offset by an increase in clinical and regulatory costs as we initiated a Phase 3 clinical trial for CTx-1301 in the first quarter of 2023.

Cingulate Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical and Business Update

Retrieved on:

Friday, March 10, 2023

KANSAS CITY, Kan., March 10, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the three and 12 months ended December 31, 2022, and provided a clinical and business update. Highlights include multiple clinical updates on CTx-1301, the Company’s lead candidate being investigated as a true, once-daily treatment for attention deficit/hyperactivity disorder (ADHD).

Key Points:

Highlights include multiple clinical updates on CTx-1301, the Company’s lead candidate being investigated as a true, once-daily treatment for attention deficit/hyperactivity disorder (ADHD).
Dr. Childress has conducted over 180 clinical studies and is considered a preeminent global ADHD expert.
CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
In addition, the Company’s manufacturing costs increased in 2022 relating to the production of clinical supply for Phase 3 trials of CTx-1301.

Fabre-Kramer Submits NDA Amendment for EXXUA™ for Treatment of Major Depressive Disorder

Retrieved on:

Wednesday, January 4, 2023

HOUSTON, Jan. 4, 2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant EXXUA™ (gepirone ER) for treatment of Major Depressive Disorder (MDD).

Key Points:

FDA has previously confirmed EXXUA's efficacy in the treatment of MDD and stated that no relevant safety issues preclude an approval recommendation.
Studied in over 5,000 patients, EXXUA's unique mechanism of targeted single serotonin (5HT) 1a receptor agonism relieves depressive symptoms without significant side effects.
In late 2021 FDA imposed safety labeling warning of serious risk of sexual dysfunction on all SSRI and SNRI products.
Major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of worthlessness, low energy, and other emotional and physical symptoms, and impairment of important functioning.