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CING FDA decision: Jun 2, 2026

Updated ·next FDA decision on the calendar
✕ COMPLETE RESPONSE LETTER

Cingulate Inc.: CTx-1301 (fixed dose, pediatric study) · ADHD.

Run-up into the decision (T-120 → T+5)

PDUFA 6/2/26$11.66$3.612/16/25
Daily close, T-120 (12/16/25) through T+5. Run-up high $11.66 on 3/19/26, low $3.6 on 6/1/26 (T-120 to T-1). FDA decision 6/2/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-02
OutcomeCRL
Drug / candidateCTx-1301 (fixed dose, pediatric study)
CompanyCingulate Inc.
120-day run-up (T-120→T-1)-8.2%

Questions

Was CTx-1301 (fixed dose, pediatric study) approved by the FDA?

Not in this review cycle. On June 2, 2026 the FDA issued a Complete Response Letter, declining to approve the application for CTx-1301 (fixed dose, pediatric study) in its current form. A CRL is not final; the primary source is linked on this page.

Which company is behind CTx-1301 (fixed dose, pediatric study)?

CTx-1301 (fixed dose, pediatric study) is a Cingulate Inc. (CING) program. The FDA decision came on June 2, 2026; the company's own announcement is linked on this page.

How did CING stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), CING moved -8.2%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.