FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date
Cingulate Inc. (CING)
Company Research
Source: GlobeNewswire
Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company’s lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the Agency has determined the submission is sufficiently complete to permit substantive review. A Key Regulatory Milestone Und
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 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
- Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301 [Yahoo! Finance]Yahoo! Finance
CING
Sec Filings
- 11/13/25 - Form 8-K
- 11/10/25 - Form 4
- 11/10/25 - Form 4
- CING's page on the SEC website