“Cingulate has achieved major development milestones in the second quarter of 2024 relating to our first product candidate, CTx-1301 for the treatment of ADHD. The combination of the Food and Drug Administration clearance for filing for marketing approval and completion of the registration batches keeps us on the path to a targeted NDA submission in the first half of 2025. We are further encouraged by a recent M&A transaction announced in the ADHD space as we continue to explore licensing opportunities for CTx-1301 in and outside the United States,” said Shane Schaffer, Chief Executive Officer of Cingulate.
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