Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301
Cingulate Inc. (CING)
Company Research
Source: GlobeNewswire
KANSAS CITY, Kan., April 03, 2025 (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 held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) yesterday to discuss the submission of a new drug application (NDA) for its lead Phase 3 asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). “Our meeting with the FDA yesterday was very productive, and we remain on track for an NDA filing of CTx-1301 in mid-2025. We truly appreciate the FDA personnel who have been involved with the regulatory review of CTx-1301 to date. These interactions have been essential in helping us generate data to demonstrate the consistency and therapeutic benefit of our product. This important milestone is validation of ou
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CING
News
- Cingulate (NASDAQ:CING) had its price target lowered by analysts at Ascendiant Capital Markets from $62.00 to $58.00. They now have a "buy" rating on the stock.MarketBeat
- Cingulate (NASDAQ:CING) had its price target lowered by analysts at Roth Capital from $17.00 to $16.00. They now have a "buy" rating on the stock.MarketBeat
- CING: Third Quarter Results [Yahoo! Finance]Yahoo! Finance
- Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update [Yahoo! Finance]Yahoo! Finance
- Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate UpdateGlobeNewswire
CING
Sec Filings
- 12/15/25 - Form 8-K
- 11/13/25 - Form 8-K
- 11/10/25 - Form 4
- CING's page on the SEC website