Cingulate Inc. (CING) on Tuesday said the U.S. Food and Drug Administration has issued a Complete Response Letter for its New Drug Application seeking approval of CTx-1301 for the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD).
The company said the FDA's response identified specific requests related to Chemistry, Manufacturing and Controls (CMC) information and did not raise any concerns regarding the clinical safety or efficacy of CTx-1301.
"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," said Cingulate CEO Shane J. Schaffer.
The company's shares were up more than 5% in pre-market trading after closing at $3.60 on Monday.
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