secwatch.observer — SEC 8-K summary
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Issuer:     Cingulate Inc. (CING)
CIK:        0001862150
Form:       8-K
Filed at:   2025-03-04T23:59:59+00:00
Accession:  0001493152-25-008988
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cingulate reports Phase 3 safety data for ADHD drug CTx-1301; no serious adverse events in final trials
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- No serious treatment-emergent adverse events, deaths, or clinically relevant trends in two pediatric Phase 3 studies and one food-effect study.
- Food-effect study with 50mg dose shows CTx-1301 can be taken with or without food, consistent with prior 25mg study.
- Final combined adult and pediatric safety and efficacy analysis expected mid-2025 for NDA submission.
- Pre-NDA in-person meeting with FDA scheduled for April 2, 2025.
- Company had 3,647,655 shares of common stock outstanding as of March 4, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1862150/000149315225008988/0001493152-25-008988-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1862150/000149315225008988/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-008988

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