{"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","discovered_at":"2026-05-14T18:02:40.863744+00:00","generated_at":"2026-05-17T03:58:39.172684+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Cingulate's NDA for CTx-1301 in ADHD; PDUFA date May 31, 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-017931","json":"https://secwatch.observer/filing/0001493152-25-017931.json","markdown":"https://secwatch.observer/filing/0001493152-25-017931.md","text":"https://secwatch.observer/filing/0001493152-25-017931.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:58:39.172684+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}