---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-050870"
form_type: "8-K"
ticker: "CING"
cik: "0001862150"
company_name: "Cingulate Inc."
filed_at: "2026-11-10T13:10:20+00:00"
generated_at: "2026-11-10T13:15:05.452547+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Cingulate expects CTx-1301 NDA resubmission in Dec 2026-Jan 2027 after CMC-only CRL

## Summary
- FDA issued a Complete Response Letter for CTx-1301 on June 1, 2026, after accepting the NDA in October 2025 with a May 31, 2026 PDUFA date.
- The CRL sought additional chemistry, manufacturing and controls information and raised no clinical safety or efficacy concerns, Cingulate said.
- Cingulate and its contract manufacturer have substantially completed the CMC manufacturing work; NDA resubmission is expected between December 2026 and January 2027.
- FDA would classify the resubmission as Class 1 with a 2-month review goal or Class 2 with a 6-month goal; launch could begin in Q3 2027 if approved.
- CEO Shane J. Schaffer discussed the timeline in an Innovators with Jane King interview; CCO Bryan Downey presented commercialization plans at the Indegene Digital Summit.

## SEC filing metadata
- accession: 0001493152-26-050870
- form_type: 8-K
- ticker: CING
- cik: 0001862150
- company_name: Cingulate Inc.
- filed_at: 2026-11-10T13:10:20+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1862150/000149315226050870/0001493152-26-050870-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1862150/000149315226050870/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-050870
- JSON: https://secwatch.observer/filing/0001493152-26-050870.json
- Plain text: https://secwatch.observer/filing/0001493152-26-050870.txt

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