Cingulate (CING) submitted its New Drug Application to the U.S. Food and Drug Administration for CTx-1301, the company’s lead asset for the treatment of Attention Deficit/Hyperactivity Disorder. CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. Cingulate may learn if the NDA has been accepted for review by the FDA within 60 days of its July 31 submission.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on CING:
- Cingulate Inc. Receives Buy Rating: PDUFA Fee Waiver and Competitive Edge of CTx-1301 Boost Market Prospects
- Cingulate receives $4.3M waiver from FDA for NDA for CTx-1301
- Cingulate Inc’s Recent Unregistered Equity Securities Sales
- Cingulate Inc Enters $25M Purchase Agreement with Lincoln Park
- Cingulate files to sell 2.5M shares of common stock for holders