Cingulate Inc. - 8-K Filing
Cingulate Inc. filed an 8-K on June 2, 2026 to disclose that the FDA issued a Complete Response Letter for its New Drug Application for CTx-1301 (dexmethylphenidate HCl) for ADHD treatment. The CRL included specific Chemistry, Manufacturing and Controls information requests but did not raise concerns about clinical safety or efficacy. The company plans to resubmit the requested data promptly. (Items: 7.01 Regulation FD Disclosure, 8.01 Other Events, 9.01 Financial Statements and Exhibits)
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