Market PotentialConsidering the ongoing stimulant shortages and that CTx-1301 only requires one daily dose, the commercial opportunity for Cingulate is considered attractive.
Partnership And CommercializationCingulate announced a partnership with Bend Bio Sciences to be the exclusive commercial manufacturer of CTx-1301 in the U.S. through 2028, assuming approval.
Regulatory ProgressCingulate announced it received a PDUFA fee waiver from the FDA worth ~$4.3M for its first NDA filing for CTx-1301 for treating Attention Deficit/Hyperactivity Disorder (ADHD), paving the way for its NDA filing.