secwatch.observer — SEC 8-K summary
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Issuer:     Cingulate Inc. (CING)
CIK:        0001862150
Form:       8-K
Filed at:   2025-10-14T23:59:59+00:00
Accession:  0001493152-25-017931
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1862150/000149315225017931/0001493152-25-017931-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1862150/000149315225017931/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-017931

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