Associated tags: Behavior, FDA, Safety, Attention, ADHD, Brain, Health, Norepinephrine, Patient, PTR, Cingulata, Precision Time Protocol Industry Profile, Adolescence, Pharmaceutical industry, Attention deficit hyperactivity disorder predominantly inattentive, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Dietary supplement, Behavioral medicine, New Drug Application, NDA, Psychiatry
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Pharmaceutical industry KANSAS CITY, Kan., May 21, 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 that it has received confirmation from and is aligned with the U.S. Food and Drug Administration (FDA) on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older.
Key Points:
- “We are pleased with the FDA’s guidance and perspective regarding our pathway to a timely NDA filing, and we will proceed to complete all remaining requirements accordingly,” said Cingulate Chairman and CEO Shane J. Schaffer.
- Many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day.
- The Cingulate poster presented at APSARD provided additional insight regarding CTx-1301’s ADHD leading effect size.
- Effect size conveys clinical significance rather than statistical significance, is not reliant on sample size, and allows for comparison across trials.
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
Retrieved on:
Tuesday, February 13, 2024
KANSAS CITY, Kan., Feb. 13, 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 has appointed three new directors to its board: Jay Roberts, Bryan Lawrence, and Jeff Ervin.
Key Points:
- KANSAS CITY, Kan., Feb. 13, 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 has appointed three new directors to its board: Jay Roberts, Bryan Lawrence, and Jeff Ervin.
- The appointment of the new directors follows the completion of the Company’s recent follow-on offering of $7.5 million in February 2024, sales under the Company’s at-the-market offering (ATM) facility in January 2024 of $3.2 million, as well as the conversion of $3.3 million of outstanding debt into equity at a 10 percent premium to market.
- “We always look forward to adding directors who complement our management team, mission and overall vision, and we are pleased to welcome Jay, Bryan and Jeff to our board,” said Cingulate Chairman and CEO Shane J. Schaffer.
- “We believe their collective experience in business, public markets, finance, healthcare and pharmaceuticals will be instrumental to the Company as we move forward with our clinical trials and business opportunities.”
The closing price of Cingulate’s common stock on Nasdaq on January 24, 2024 was $4.35 per share.
Key Points:
- The closing price of Cingulate’s common stock on Nasdaq on January 24, 2024 was $4.35 per share.
- Cingulate, Cingulate Therapeutics LLC (CTx) and WFIA entered into a Note Conversion Agreement on January 25, 2024, pursuant to which WFIA agreed to convert the remaining $3.0 million of principal under its outstanding note, plus all accrued interest thereon, or $3.3 million total, into pre-funded warrants (“the Pre-Funded Warrants”) to purchase 687,043 shares of Cingulate’s common stock.
- The Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of $0.0001 per share, subject to a beneficial ownership blocker of 19.99%.
- Following the conversion, all debt and accrued interest with WFIA is paid in full.
Retrieved on:
Tuesday, October 17, 2023
ADHD,
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Union League Club,
Screen for child anxiety related disorders,
Cingulata,
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Nightclub The live-streamed event will be held from 10:00am-11:30am EST at the Union League Club in Midtown Manhattan, and will focus on the Company’s leading, late-stage asset CTx-1301(dexmethylphenidate), along with ADHD and anxiety-related disorders.
Key Points:
- The live-streamed event will be held from 10:00am-11:30am EST at the Union League Club in Midtown Manhattan, and will focus on the Company’s leading, late-stage asset CTx-1301(dexmethylphenidate), along with ADHD and anxiety-related disorders.
- For those in the New York area who would like to attend, there will be space for approximately 25-30 guests in the club’s Grant Room.
- Those who wish to watch the event virtually may do so through the link provided here , with the passcode 429018.
- “The Cingulate team thanks Dr. Childress and Dr. Mattingly for their participation in this event.
Retrieved on:
Monday, September 11, 2023
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Cingulata,
ADHD,
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Hour,
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Attention deficit hyperactivity disorder predominantly inattentive,
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Dietary supplement KANSAS CITY, Kan., Sept. 11, 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, announced full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD), presented on September 8th at the 36th Annual Psych Congress, in Nashville, TN. A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
Key Points:
- A poster describing this data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
- The Phase 3 CTx-1301-022 study ( NCT05631626 ) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting.
- “Along with a restricted duration of efficacy, another limitation of current stimulant-based treatments for ADHD is the phenomena of crash and rebound they produce.
- Additionally, CTx-1301 demonstrated a reduction in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores (-16.3).
Retrieved on:
Friday, September 8, 2023
The closing price of Cingulate’s common stock on Nasdaq on September 8, 2023 was $0.5776 per share.
Key Points:
- The closing price of Cingulate’s common stock on Nasdaq on September 8, 2023 was $0.5776 per share.
- The debt conversion follows WFIA’s purchase of $1.0 million of Cingulate common stock in a private placement transaction in August 2023.
- The Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of $0.0001 per share, subject to a beneficial ownership blocker of 19.99%.
- Following the conversion, $3.0 million in principal plus $0.1 million in accrued interest remained outstanding under the WFIA note which matures in August 2025.
Retrieved on:
Tuesday, September 5, 2023
Psych,
Cingulata,
Doctor of Pharmacy,
New Drug Application,
ADHD,
NDA,
A2,
Research,
Attention deficit hyperactivity disorder predominantly inattentive,
Poster,
Patient,
Behavioral medicine,
Psychiatry,
Adolescence,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Precision Time Protocol Industry Profile,
Food,
Safety,
Pharmaceutical industry,
Dietary supplement The poster was accepted as a finalist for the first annual Psych Congress Poster Awards, which will be awarded onsite at the conference.
Key Points:
- The poster was accepted as a finalist for the first annual Psych Congress Poster Awards, which will be awarded onsite at the conference.
- The data demonstrated a trend towards significance in improving ADHD symptoms with a rapid onset of action and entire active-day duration.
- In addition to the Phase 3 adult dose-optimization study, Cingulate initiated its pivotal Phase 3 fixed-dose pediatric and adolescent study in July 2023, as well as a dose-optimization onset and duration study in pediatric patients in August 2023.
- Assuming positive clinical results from the 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.
Meta-analysis,
Cingulata,
Doctor of Pharmacy,
New Drug Application,
ADHD,
NDA,
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Attention deficit hyperactivity disorder predominantly inattentive,
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Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Precision Time Protocol Industry Profile,
Food,
Safety,
Dietary supplement,
Pharmaceutical industry Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.
Key Points:
- Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.
- After a 5-week dose optimization period, subjects were either randomized to their optimized dose of CTx-1301 or placebo.
- In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study this month and a dose-optimization onset and duration trial in pediatric patients in August 2023.
- Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
Cingulata,
New Drug Application,
ADHD,
NDA,
Doctor of Philosophy,
Society,
Attention deficit hyperactivity disorder predominantly inattentive,
Patient,
Adolescence,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Precision Time Protocol Industry Profile,
Food,
Pharmaceutical industry All doses of CTx-1301 are now available for both pivotal Phase 3 pediatric and adolescent clinical trials, with the fixed-dose study scheduled to begin the week of July 24.
Key Points:
- All doses of CTx-1301 are now available for both pivotal Phase 3 pediatric and adolescent clinical trials, with the fixed-dose study scheduled to begin the week of July 24.
- “We have effectively collaborated with our manufacturing partner, Societal CDMO, to successfully manufacture all doses required to initiate our pivotal Phase 3 pediatric and adolescent clinical program, and we look forward to the initiation of the fixed-dose study,” said Laurie A. Myers, PhD, Chief Operating Officer, Cingulate.
- Cingulate recently completed a Phase 3 adult onset and duration study of CTx-1301 with results expected 3Q 2023.
- Assuming positive clinical results from its Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
