Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
Cingulate Inc. (CING)
Company Research
Source: GlobeNewswire
Twelve Required Registration Batches CompletedNew Drug Application Being Prepped for Submission KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In alignment with U.S. Food and Drug Administration (FDA) requirements, 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 completed the manufacturing of its twelve registration batches for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Registration batches are required by the U.S. Food and Drug Administration (FDA) to be manufactured before submitting a new drug application (NDA) using the actual equipment, dosage strengths and procedures that will be used to commercialize the drug product candidate. “This achievement brings us one step closer to complia
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News
- Cingulate Announces Exercise of Warrants for $1.86 Million Gross Proceeds [Yahoo! Finance]Yahoo! Finance
- Cingulate Announces Exercise of Warrants for $1.86 Million Gross ProceedsGlobeNewswire
- Cingulate and ADHD Expert Dr. Ann Childress, MD to Participate in Benzinga All Live Access EventGlobeNewswire
- Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance [Yahoo! Finance]Yahoo! Finance
- $10.9 Billion Attention Deficit Hyperactivity Disorder (ADHD) Opportunity Assessment and Forecasts 2022-2024 & 2032: Epidemiology, Symptoms, Diagnosis, Disease Management, Revenue, Unmet Needs [Yahoo! Finance]Yahoo! Finance
CING
Sec Filings
- 6/28/24 - Form DEF
- 6/27/24 - Form SC
- 6/18/24 - Form PRE
- CING's page on the SEC website