Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025
Cingulate Inc. (CING)
Company Research
Source: GlobeNewswire
Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2 CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day KANSAS CITY, Kan., March 04, 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, today released Phase 3 safety data for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The data readout includes safety data from two Phase 3 pediatric and adolescent studies – a fixed dose study and a dose optimization study – as well as a food effect study with healthy adults, using a single 50mg dose of CTx-1301, Cingulate’s highest dosage. The safety results of these studies have been analyzed and submitted to the FDA in preparation for an in-pers
Show less
Read more
Impact Snapshot
Event Time:
CING
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
CING alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
CING alerts
High impacting Cingulate Inc. news events
Weekly update
A roundup of the hottest topics
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