Cingulate Gets FDA Request for Updates on ADHD Drug Application
By Katherine Hamilton
Cingulate said the Food and Drug Administration flagged certain chemistry, manufacturing and controls requests in response to its application for a drug treating ADHD.
The Kansas City, Kan., biopharmaceutical company said Tuesday it received a complete response letter from the FDA for its new drug application for CTx-1301, a treatment for attention deficit/hyperactivity disorder.
The response identified chemistry, manufacturing and controls information requests, but didn't raise any concerns about the clinical safety or efficacy of the drug.
Cingulate said it plans to promptly submit the requested information addressing issues raised.
Chief Executive Shane Schaffer said the company has nearly $30 million in cash reserves, which management believes will be enough to address the issues raised and resubmit the application, while continuing pre-commercial activities.
"We believe the outstanding requests will be addressed quickly as we move efficiently toward resubmission," Schaffer said.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
June 02, 2026 08:34 ET (12:34 GMT)
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