secwatch.observer — SEC 8-K summary
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Issuer:     Cingulate Inc. (CING)
CIK:        0001862150
Form:       8-K
Filed at:   2025-01-07T23:59:59+00:00
Accession:  0001493152-25-001113
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cingulate completes final FDA-required food effect study for CTx-1301; NDA submission targeted mid-2025
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- Completed food effect study for CTx-1301 (dexmethylphenidate) in 26 healthy adults using 50mg dose.
- No serious adverse events reported; data readout on bioavailability with/without food expected Q2 2025.
- Final FDA-required study before NDA submission, which is planned for mid-2025.
- 2022 study with 25mg dose already showed CTx-1301 can be taken with or without food.
- CTx-1301 designed as once-daily stimulant for ADHD covering entire active day.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1862150/000149315225001113/0001493152-25-001113-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1862150/000149315225001113/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-001113

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