---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-017931"
form_type: "8-K"
ticker: "CING"
cik: "0001862150"
company_name: "Cingulate Inc."
filed_at: "2025-10-14T23:59:59+00:00"
generated_at: "2026-05-17T03:58:39.172684+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Cingulate's NDA for CTx-1301 in ADHD; PDUFA date May 31, 2026

## Summary
- FDA accepted NDA for CTx-1301 (dexmethylphenidate), a once-daily PTR stimulant for ADHD in children and adults, under 505(b)(2) pathway.
- PDUFA target action date is May 31, 2026; acceptance confirms submission sufficiently complete for substantive review.
- Phase 3 trials showed large effect sizes on PERMP, AISRS, ADHD-RS-5, CGI scales; no serious treatment-emergent adverse events.
- Commercial readiness: process transfer and scale-up completed with Bend Bio Sciences; AI-driven omnichannel platform with Indegene launched.
- Early payer research indicates strong formulary receptivity for once-daily CTx-1301, aligning with adherence priorities in ADHD care.

## SEC filing metadata
- accession: 0001493152-25-017931
- form_type: 8-K
- ticker: CING
- cik: 0001862150
- company_name: Cingulate Inc.
- filed_at: 2025-10-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1862150/000149315225017931/0001493152-25-017931-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1862150/000149315225017931/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-017931
- JSON: https://secwatch.observer/filing/0001493152-25-017931.json
- Plain text: https://secwatch.observer/filing/0001493152-25-017931.txt

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