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ADHD drug delivery specialist Cingulate hit with manufacturing-related FDA rejection
After submitting its timed-release version of a decades-old ADHD drug to the FDA nearly a year ago, Kansas City's Cingulate has suffered a setback in its bid to commercialize its first product.&nbs | Cingulate will need to take a detour to win its first FDA approval, as the agency has rejected its lead candidate over manufacturing concerns.
TL;DRAI
Cingulate receives FDA rejection for CTx-1301 (ADHD timed-release) due to manufacturing issues, not efficacy; $30M cash available to address. The delay underlines how manufacturing scalability remains critical for biotech time-to-market and competitive positioning.
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