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Cingulate Receives Complete Response Letter from FDA for CTx-1301
Cingulate Receives Complete Response Letter from FDA for CTx-1301
About this update from Cingulate Inc.
No Clinical Safety or Efficacy Concerns Currently Identified Agency Feedback Primarily Focused on CMC-Related RequestsCompany Plans Prompt Response and Submission of Requested InformationCompany is Well Capitalized with Nearly $30 Million Cash on Hand KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- 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 specific information requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301,” said Cingulate CEO Shane J. Schaffer. “Our immediate priority is to complete the CMC work already underway with our manufacturing partner; we believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission. Importantly, we have nearly $30 million in cash reserves, which we believe provides sufficient capital to address the issues raised and execute on the resubmission process and continue pre-commercial activities into 2027.” About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the U.S. ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively trea...