Cingulate receives FDA Complete Response Letter for CTx-1301; no safety/efficacy issues, CMC-only

Cingulate Inc.

FDA issued a Complete Response Letter for CTx-1301 (dexmethylphenidate HCl) NDA for ADHD.
No current concerns about clinical safety or efficacy; CMC information requests identified.
Company expects prompt resubmission of requested CMC data; has ~$30M cash on hand.
NDA previously accepted with PDUFA target date of May 31, 2026.

item 7.01 item 8.01 item 9.01

Featured in Daily 8-K Digest

Selected #2 for 2026-06-02. Read digest

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001493152-26-026760
form_type: 8-K
ticker: CING
cik: 0001862150
company_name: Cingulate Inc.
filed_at: 2026-06-02T12:10:25+00:00
discovered_at: 2026-06-02T12:15:00.454990+00:00
generated_at: 2026-06-02T12:15:12.009106+00:00
sec_items: ["7.01", "8.01", "9.01"]
event_type: regulatory
sentiment: negative
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: high
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json_url: https://secwatch.observer/filing/0001493152-26-026760.json
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review_status: machine_generated
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