Cingulate Inc. (NASDAQ:CING) experienced a steep decline in its share price after the company announced it had received a Complete Response Letter from the U.S. Food and Drug Administration related to its New Drug Application for CTx-1301, an investigational treatment for Attention Deficit/Hyperactivity Disorder.
According to the company's statement, the FDA's communication was confined to specific requests for additional Chemistry, Manufacturing and Controls (CMC) information. The agency did not raise issues concerning the clinical safety or efficacy of CTx-1301, the company said.
CTx-1301 is built on Cingulate's Precision Timed Release drug delivery technology and lists dexmethylphenidate HCl as its active pharmaceutical ingredient. In its announcement, Cingulate said it intends to promptly provide the requested CMC data to address the points identified by the FDA.
In a quoted remark, CEO Shane J. Schaffer said the company was "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." Cingulate added that its immediate priority is to finish the CMC activities already underway in coordination with its manufacturing partner.
The company reported having nearly $30 million in cash on hand and stated it believes those resources are adequate to respond to the FDA's requests and complete the resubmission process. Cingulate also said it expects to continue pre-commercial work into 2027.
Investors reacted to the FDA letter by selling shares, resulting in the reported decline in Cingulate's stock price. The firm's stated operational focus following the letter centers on supplying the agency with the CMC information it requested and advancing the manufacturing work in partnership with its contract manufacturer.
Contextual note - The company relayed the FDA's findings in its corporate announcement and outlined next steps, including prompt submission of the requested information and continuation of pre-commercial activities supported by its cash reserves.