Filed with the SEC on · accession 0001493152-26-050870
CING filed a 8-K (current report) with the SEC on Nov 10, 2026. Cingulate Inc. provided an update on its efforts to address the FDA's Complete Response Letter (CRL) for its CTx-1301 NDA, which was received on June 1, 2026, citing only CMC requests and no clinical safety or efficacy concerns. The stock moved +4.7% by the first close after the filing.
Cingulate Inc. provided an update on its efforts to address the FDA's Complete Response Letter (CRL) for its CTx-1301 NDA, which was received on June 1, 2026, citing only CMC requests and no clinical safety or efficacy concerns. The company expects to resubmit the NDA between December 2026 and January 2027, with potential commercial launch in Q3 2027 if approved.
Close before
$4.45
Nov 9, 2026
First close after
+4.72%
$4.66
5 trading days
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Since filing
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Click hereCING filed a 8-K (Fda rejection). Cingulate Inc. provided an update on its efforts to address the FDA's Complete Response Letter (CRL) for its CTx-1301 NDA, which was received on June 1, 2026, citing only CMC requests and no clinical safety or efficacy concerns. The company expects to resubmit the NDA between December 2026 and January 2027, with potential commercial launch in Q3 2027 if approved.
For a small biotech one drug can be most of the company’s value. Approval opens sales; a rejection (complete response letter) can delay it by years.
A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more. The "Item" number tells you the topic (e.g. 2.02 results, 5.02 executive change, 1.01 new agreement, 1.03 bankruptcy). Exhibits (99.1 press release) usually hold the details.
Public companies must tell the SEC about anything that can change their value — results, leadership changes, big deals, new shares, bankruptcy. Filings are the official source, often before the news. A 8-K (current report): A report of a major event, filed within four business days: results, deals, leadership changes, bankruptcy and more.
CING closed at $4.45 before the filing and $4.66 on Nov 10, 2026 (+4.72%).
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