secwatch.observer — SEC 8-K summary
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Issuer:     Cingulate Inc. (CING)
CIK:        0001862150
Form:       8-K
Filed at:   2026-11-10T13:10:20+00:00
Accession:  0001493152-26-050870
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1862150/000149315226050870/0001493152-26-050870-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1862150/000149315226050870/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-050870

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