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Cingulate's ADHD Drug CTx-1301 Advances Toward 2026 FDA Decision

Cingulate advances CTx-1301 ADHD treatment with FDA acceptance and 2026 PDUFA date. Stonegate updates coverage as company prepares for potential commercial launch.

The advancement of CTx-1301 represents a potential breakthrough in ADHD treatment, addressing the critical need for medications that provide both rapid onset and sustained full-day symptom control. For the approximately 6 million children and 10 million adults in the U.S. living with ADHD, current treatments often involve trade-offs between quick relief and duration of effect, requiring multiple doses or supplemental medications. CTx-1301's innovative triple-release technology could significantly improve treatment adherence and quality of life for patients while reducing the burden on caregivers and educators. The successful development and potential approval of this medication could establish a new standard in ADHD care and validate Cingulate's PTR platform for broader application across neuropsychiatric conditions, potentially transforming treatment approaches for millions of patients worldwide.