Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
The FDA's own letter · Complete Response Letter, NDA 220283 (PDF), dated May 29, 2026, released under FDA's CRL transparency program. The company announced the decision on June 2, 2026; the FDA acted on May 29, 2026.
Sections the letter addresses (its own headings, read from the PDF's text layer; labeling and administrative sections omitted): Product Quality; Facility Inspections.
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.
Positioning before the decision
On May 20, 2026, 13 days before the decision date, at-the-money options priced a move of ±63.9% through Jun 18, 2026 (the first listed expiry after the decision; ATM implied volatility 282%). The stock closed +11.9% at the first close across the decision and +25.8% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Drug / candidateCTx-1301 (fixed dose, pediatric study)
CompanyCingulate Inc.
120-day run-up (T-120→T-1)-8.2%
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was CTx-1301 (fixed dose, pediatric study) approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for CTx-1301 (fixed dose, pediatric study) in its current form, was announced on June 2, 2026. 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 company announced the FDA decision on June 2, 2026; the FDA's own record of the decision 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.
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