Cingulate receives $4.3M waiver from FDA for NDA for CTx-1301

Cingulate (CING) announced that it has received a fiscal year 2025 PDUFA, Prescription Drug User Fee Act, fee waiver from the U.S. Food and Drug Administration, FDA, for its new drug application, NDA, for lead asset CTx-1301 for the treatment of Attention Deficit Hyperactivity Disorder, ADHD. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act, FD&C Act, the waiver will save Cingulate approximately $4.3 million as the company prepares to submit its NDA at the end of this month. “We are pleased to receive this significant waiver as we approach the submission of our NDA in the coming days and look forward to continuing to work with the FDA throughout the submission and review process,” said Cingulate Chairman and CEO Shane Schaffer. “This waiver will save Cingulate more than $4 million and strengthen our financial position as we prepare to commercialize CTx-1301.”