secwatch.observer — SEC 8-K summary
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Issuer:     Cingulate Inc. (CING)
CIK:        0001862150
Form:       8-K
Filed at:   2025-08-06T23:59:59+00:00
Accession:  0001641172-25-022360
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cingulate submits NDA to FDA for lead ADHD drug CTx-1301
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- Submitted NDA on July 31, 2025 for CTx-1301 (dexmethylphenidate) for ADHD.
- FDA will decide on acceptance within 60 days of July 31 submission.
- Drug designed as novel extended-release tablet for once-daily, entire active-day symptom control.
- Cingulate targets $23B U.S. ADHD market; over 20M patients diagnosed in US.
- NDA is first regulatory application of company's proprietary Precision Timed Release platform.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1862150/000164117225022360/0001641172-25-022360-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1862150/000164117225022360/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-022360

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer