EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Cingulate Receives Complete Response Letter from FDA for CTx-1301 No Clinical Safety or Efficacy Concerns Currently Identified Agency Feedback Primarily Focused on CMC-Related Requests Company Plans Prompt Response and Submission of Requested Information Company is Well Capitalized with Nearly $30 Million Cash on Hand KANSAS CITY, Kan., June 2, 2026 - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The response identified specific Chemistry, Manufacturing and Controls (CMC) information requests and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301. Cingulate expects a prompt submission to FDA of the requested information addressing issues raised. “We are encouraged that the FDA’s response was limited to s…
Open exhibit ↗Current Report · Items 7.01, 8.01, 9.01 · 8-K
Cingulate Inc.
CINGNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 8.01 Other Events. On June 2, 2026, the Company announced that the FDA has issued a CRL for its New Drug Application for CTx-1301. The FDA identified specific Chemistry, Manufacturing and Controls information requests in the CRL and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301.…
Company context
We are a biopharmaceutical company using our proprietary Precision Timed ReleaseTM (PTRTM) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (“ADHD”) and anxiety, we are identifying and evaluating additional therapeutic areas where our PTR technology may be employed to develop future product candidates. Our PTR platform incorporates a proprietary Erosion Barrier Layer (“EBL”) designed to allow for the release of drug substance at specific, pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets. We believe there remains a significant, unmet need within the current treatment paradigm for true once-daily ADHD stimulant medications with lasting duration and a superior side effect profile to better serve the needs of patients throughout their entire active-day.
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Recent company filings
- 10-Q filingAug 13, 2026
- Results of Operations and Financial ConditionAug 13, 2026
- Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory ArrangementsJul 23, 2026
- S-8 filingJul 15, 2026
- Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Submission of Matters to a Vote of Security HoldersJul 14, 2026