---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-026760"
form_type: "8-K"
ticker: "CING"
cik: "0001862150"
company_name: "Cingulate Inc."
filed_at: "2026-06-02T12:10:25+00:00"
generated_at: "2026-06-02T12:15:12.009106+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Cingulate receives FDA Complete Response Letter for CTx-1301; no safety/efficacy issues, CMC-only

## Summary
- FDA issued a Complete Response Letter for CTx-1301 (dexmethylphenidate HCl) NDA for ADHD.
- No current concerns about clinical safety or efficacy; CMC information requests identified.
- Company expects prompt resubmission of requested CMC data; has ~$30M cash on hand.
- NDA previously accepted with PDUFA target date of May 31, 2026.

## SEC filing metadata
- accession: 0001493152-26-026760
- form_type: 8-K
- ticker: CING
- cik: 0001862150
- company_name: Cingulate Inc.
- filed_at: 2026-06-02T12:10:25+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/0001493152-26-026760-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-026760
- JSON: https://secwatch.observer/filing/0001493152-26-026760.json
- Plain text: https://secwatch.observer/filing/0001493152-26-026760.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.