FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD [Yahoo! Finance]
Cingulate Inc. (CING)
Company Research
Source: Yahoo! Finance
CTx-1301 Could Benefit 60% of ADHD Patients Currently Using Immediate-Release Booster Doses Advancing Discussions with Commercialization Partners Ready to Engage with Payers for Reimbursement and Market Access 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. Details from the FDA communication to Cingulate include the following: Per the 505(b)(2) pathway, submission of CTx-1301's NDA does not require co
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CING
News
- FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHDGlobeNewswire
- Cingulate Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update [Yahoo! Finance]Yahoo! Finance
- Cingulate Reports First Quarter 2024 Financial Results and Provides Clinical and Business UpdateGlobeNewswire
- Peter J. Werth, Successful Pharma Entrepreneur, Philanthropist, Cingulate Investor and Board Member, to be Featured with Chairman and CEO Shane J. Schaffer on Benzinga All Live Access [Yahoo! Finance]Yahoo! Finance
- Peter J. Werth, Successful Pharma Entrepreneur, Philanthropist, Cingulate Investor and Board Member, to be Featured with Chairman and CEO Shane J. Schaffer on Benzinga All Live AccessGlobeNewswire
CING
Sec Filings
- 6/13/24 - Form 4
- 6/13/24 - Form 4
- 6/13/24 - Form 4
- CING's page on the SEC website